HN-2

Disease

Head and Neck Squamous Cell Carcinoma (HNSCC)

Type and Number of Samples

• Prospective
• Matched Fresh Tissue and Whole blood (or PBMCs), 10 subjects

Specific Requirements

• All subtypes accepted
• Subjects confirmed positive for HPV 16for HPV 16
• Samples from biopsies and surgical resections accepted
• Minimum weight of 100 mg resected tumor tissue or at least 3 core needle biopsies (CNBs) per subject
• Minimum of 40 ml whole blood or 40 x 106 PBMCs per subject with at least 70% viability upon recovery
• Subjects confirmed negative for HIV/HCV/HBV

Associated Data Required

• Age, Gender, Ethnicity
• Sample collection date
• HPV 16 expression status
• Sample type (e.g. resection or CNB)
• For whole blood: volume of sample (ml)
• For PBMCs: number of cells per subject
• Tumor stage and grade
• Treatment history (if not treatment-naïve)
• Available mutation status information (e.g. TP53, CDKN2A, PTEN, PIK3CA, and HRAS)

SC-2

Disease

Melanoma

Type and Number of Samples

• Prospective
• 1 subject, matched samples
• Freshly resected tumor tissue (> 1 g) and Whole blood, (> 20 mL, collected in K2 EDTA tubes)

Specific Requirements

• Pathology confirmed diagnosis
• Any stage, Any subtype
• Primary and secondary (i.e. metastatic) tumors accepted
• No recent chemotherapy treatment: subjects must be treatment naïve or must have received chemotherapy more than 6 weeks prior to sample collection

Associated Data Required

• Age, Gender, Ethnicity
• Sample collection date
• Stage (TNM) and grade
• Tumor size and location (if information on metastases is available)
• HIV, HCV and HBV status

HN-1

Disease

Head and Neck Squamous Cell Carcinoma (HNSCC)

Type and Number of Samples

• Retrospective
• FFPE blocks, 40 subjects
• 5 subjects with Stage I HNSCC
• 5 subjects with Stage II HNSCC
• 5 subjects with Stage III HNSCC
• 15 subjects with Stage IV HNSCC
• 10 subjects with any stage HNSCC

Specific Requirements

• For Stage IV HNSCC: minimum of 10 subjects for which samples were collected from secondary tumor tissue (e.g. lung, liver, skin)
• For any stage HNSCC: samples from recurrent primary tumor tissue
• Subjects for all groups must be positive for HPV 16
• Tumor content ≥ 30%
• Necrosis ≤ 30%

Associated Data Required

• Age, Gender
• Year of collection
• Type of sample collection (primary or secondary site)
• Collecting site (eg. skin, brain, lung, liver)
• Sample type (e.g. resection or biopsy)
• Histological subtype
• Tumor stage and grade
• HPV 16 status
• % tumor and % necrosis per sample

OC-10

Disease

Breast cancer (non-fatty lymph nodes only) / Ovarian Cancer / Cervical Cancer / Uterine Cancer

• Colorectal cancer / H&N cancer /Gastric Cancer / Liver Cancer / Pancreatic Cancer (PDAC)
• Lung Cancer
• Renal cell carcinoma (RCC) / Bladder cancer

Type and Number of Samples

• Prospective
• 20 subjects, matched samples.
• Tumor tissue (minimum of 500mg), Lymph nodes (minimum 300 mg), 2 red-cap whole blood tubes

Specific Requirements

• Lymph nodes to be processed following the protocol provided by the study sponsor to isolate LN-derived Mononuclear Cells (LNs should be tumor free: soft by palpation) - Minimum of 10x106 Mononuclear Cells per case
• Whole blood to be processed to serum
• Therapy Naïve, post-neoadjuvant therapy, at relapse
• 70% recovery (number of cells) and 70% viability at the following steps: post-isolation (PI), pre-freeze (PF), QC (quality control) post-thaw (PT) at provider’s facility

Associated Data Required

• Age, Gender, Ethnicity
• Medical History
• Concurrent disease(s)
• Current medication provided with each patient along with de-identified pathology report

PT-1

Disease

Metastatic Castrate-Resistant Prostate Cancer (mCRPC)

Type and Number of Samples

• Retrospective
• FFPE blocks, 20 subjects

Specific Requirements

• Metastatic (secondary) tumor tissue resections only

Associated Data Required

• Age, Gender, Ethnicity
• Sample collection date
• Pathological diagnosis with microscopic description (histologic subtype)
• Tumor stage and grade (Gleason scoring)

BUO-9

Disease

Epithelial Ovarian Cancer

Type and Number of Samples

• Prospective
• Matched samples: Freshly resected tumor tissue (> 1 g) and Matched whole blood (> 20 mL, collected in K2 EDTA tubes), 1 subject

Specific Requirements

• Pathology confirmed diagnosis
• Any stage and subtype accepted
• Primary or metastatic tumors accepted
• No recent chemotherapy treatment: subjects must be treatment naïve or must have received chemotherapy more than 6 weeks prior to sample collection tumor subtypes of epithelial origin only

Associated Data Required

• Age, Gender, Ethnicity
• Sample collection date
• Stage (TNM) and grade
• Tumor size and location (if information on metastases is available)
• HIV, HCV and HBV status

BUO-8

Disease

Breast Cancer

• Triple Negative Breast Cancer (TNBC)

Type and Number of Samples

• Retrospective
• FFPE blocks Matched blocks from pre-treatment (biopsy) and post-treatment (resection), 5 sets

Specific Requirements

• Confirmed diagnosis of TNBC (HER2 negative, ER negative, PR negative)
• Any histological subtype and any stage accepted
• Primary and/or metastatic tumors

Associated Data Required

• Age, Gender
• Sample collection date
• Origin/Site of tumor
• ER, PR, and HER2 status
• Tumor Stage (TNM) and Grade
• Treatment history

BUO-7

Disease

Endometrial Cancer

Type and Number of Samples

• Retrospective
• FFPE blocks Matched blocks from pre- and post-treatment, 18 sets

Specific Requirements

• Any histological subtype and any stage accepted
• Primary tumors only for pre-treatment FFPE blocks
• Both primary and/or metastatic tumors accepted for post-treatment FFPE blocks
• Minimum tumor content: 30%

Associated Data Required

• Age, Gender
• Diagnosis with histopathological subtype
• Date of pre-treatment biopsy/resection
• Date of post-treatment biopsy/resection
• Stage (TNM)
• Treatment history

BUO-6

Disease

Breast Cancer

Type and Number of Samples

• Prospective
• EDTA Plasma, 10 subjects

Specific Requirements

• Primary or recurrent cancer
• Subjects who did not yet undergo any surgery, chemotherapy, radiation or any other treatment for this cancerous lesion (including, but not limited to systemic therapies)
• Recent cancer staging should be within 90 days prior to baseline visit
• Samples from all stages of cancer will be accepted

Associated Data Required

• Age, Gender, Ethinicity
• Sample collection date
• Height (cm), Weight (kg)
• Method of diagnosis (Screening program/Symptoms suggestive of cancer/Following incidental findings/Other-specify)
• Smoking status
• CBC (Complete Blood Count), Hemoglobin level (g/dL), Mean Corpuscular Volume (MCV), Ferritin level
• Presence of comorbidity:Chronic kidney disease, Renal failure • Cirrhosis (if yes – what is the reason? Alcohol, HBV, HCV), Diabetes, COPD, Autoimmune disease (if yes – which?)
• Family history of cancer

BUO-5

Disease

Breast Cancer

Type and Number of Samples

• Retrospective
• FFPE slides, 5 subjects

Specific Requirements

• Stage III or IV only
• Treated or untreated
• Resections and biopsies
• Primary tumors only
• Any histopathological subtype
• Tumor content ≥ 30 %

Associated Data Required

• Age, Gender, Ethinicity
• Sample collection date
• Histological subtype
• Pathological diagnosis
• Tumor stage and grade
• ER/HER2 status

IO-1

Disease

Anti-PD1 Therapy Patients

• Non-Small Cell Lung Cancer (NSCLC)

Type and Number of Samples

• Prospective
• Plasma - 10 subjects

Specific Requirements

• Subjects diagnosed with Non-Small Cell Lung Cancer (NSCLC), Renal cancer or other solid tumors
• Subjects who are going to receive anti-PD1 therapy with prospective clinical follow up

Associated Data Required

• Age, Gender
• Diagnosis
• Sample collection date

IO-2

Disease

Immunotherapy Treated Patients

• Melanoma or Non-Small Cell Lung Cancer

Type and Number of Samples

• FFPE Blocks - 50 subjects
• Prospective

Specific Requirements

• Subjects diagnosed with Non-Small Cell Lung Cancer (NSCLC) or Melanoma
• Immunotherapy treated patients, preferentially with an equal distribution for MSI-H and MSS cases (IHC, Promega or equivalent methodology)

Associated Data Required

• Age, Gender
• TNM staging
• Follow-up status (relapse, survival)
• Date of initial diagnosis
• Sample collection date
• Details of administered immunotherapy
• MSI status and Reference test used for MSI characterization
• Pathological diagnosis (Cancer Type and stage)
• Samples characterization data (total area, total tissue area, and % tumor or tumor area)

IO-3

Disease

Anti-PD1 Therapy Patients

• Non-Small Cell Lung Cancer (NSCLC) - adenocarcinoma subtype

Type and Number of Samples

• Retrospective
• FFPE Slides - 50 subjects
• 3 groups: * Responders to anti-PD1 therapy; * Responders to ati-PD1 therapy relapsing within 6 months of treatment; * Non-responders

Specific Requirements

• Subjects treated with pembrolizumab (Keytruda) or nivolumab (Opdivo) (or other anti-PD1 monoclonal antibodies)
• FFPE samples (preferably surgical resection material) collected within max of 12 months prior to therapy with anti-PD1; other previous treatments are acceptable (radio- and chemo-therapy)

Associated Data Required

• Age, Gender
• Basic pathology data
• Medications and treatments with dates
• At least 12 months clinical follow up data
• Overall survival and progression survival
• Data on relapse
• Sample collection date

IO-4

Disease

Anti-PD1 Therapy Patients

• Renal Cell Carcinoma

Type and Number of Samples

• FFPE Blocks - 10 subjects
• Retrospective

Specific Requirements

• Subjects treated with Pembrolizumab (Keytruda) or nivolumab (Opdivo)
• FFPE blocks (resection or biopsy) collected within 12 months prior to therapy
• Other previous treatments are acceptable

Associated Data Required

• Age, Gender, Ethnicity, Race and BMIN
• Basic Pathological data
• Medications and treatments
• At least 24 months clinical follow up data
• Overall survival and progression-free survival by RECIST criteria
• Data on relapse

IO-5

Disease

Anti-PD1 Therapy Patients

• Non-Small Cell Lung Cancer (NSCLC)
• Subtypes: Adenocarcinoma; Squamous Cell Carcinoma; Large Cell Carcinoma; Clear Cell Carcinoma; Adenosquamous Carcinoma

Type and Number of Samples

• Retrospective
• FFPE Blocks - 90 subjects

Specific Requirements

• Primary tumor
• Subjects without EGFR mutations
• PD-L1 positive cases (cut-off: 1%)

Associated Data Required

• Age, Gender, Ethnicity
• Sample collection date
• Pathological diagnosis with microscopic description and subtype
• Tumor Stage and Grade
• Origin/Site of tumor
• Confirmation of wild type EGFR
• PD-L1 score
• Other IHC available data (i.e. TTF-1, P40, and when applicable: chromogranin A and synaptophysin)
• % tumor and % necrosis per sample

IO-6

Disease

Anti-PD1 Therapy Patients

• Non-Small Cell Lung Cancer (NSCLC)
• Head and Neck Squamous Cell Carcinoma (HNSCC)
• Upper tract transitional cell carcinoma (UTCC)

Type and Number of Samples

• Retrospective
• FFPE Slides - 40 subjects per indication
• Sets of 3-5 FFPE tissue sections

Specific Requirements

• Subjects must have been treated with anti-PD-1 drugs (i.e. Opdivo® or Keytruda®)
• Ideally, 20 % of the subjects respond to anti PD-1 treatment (partial response or complete response)
• Samples from biopsies or surgical resections
• Tissue collected prior to anti-PD1 treatment
• Tissue samples fixed in 10 % Neutral Buffered Formalin (NBF)

Associated Data Required

• Age, gender
• Year of collection
• Pathological diagnosis with microscopic description (histological subtype)
• Tumor stage and grade
• Treatment history and medical outcome post-immunotherapy

IO-7

Disease

Anti-PD1 Therapy Patients

• Non-Small Cell Lung Cancer (NSCLC)

Type and Number of Samples

• Retrospective
• 59 FFPE blocks of PD-L1 TPS between the range 5-20%
• 28 FFPE blocks of PD-L1 TPS between the range 55-70%

Specific Requirements

• Any stage; Any subtype
• FFPE blocks are to be evaluated for expression level (tumor proportion score (TPS)) of Programmed Death Ligand 1 (PD-L1)
• FFPE blocks that allow the cutting of ≥ 50 sections of 4 µm
• Tumor content ≥30%
• Tissue samples fixed in 10% Neutral Buffered Formalin (NBF) between 12 to 72 hours

Associated Data Required

• Age, Gender
• Date of sample collection
• Confirmation of diagnosis along with histological subtype
• PD-L1 TPS score (%)
• Fixation time

IO-8

Disease

Anti-PD1 Therapy Patients

• Non-Small Cell Lung Cancer (NSCLC)
• Colorectal Carcinoma

Type and Number of Samples

• Retrospective
• FFPE Blocks - total of 50 subjects
• NSCLC Adenocarcinoma ALK positive (N=13)
• NSCLC Adenocarcinoma PD-L1 (SP142) positive (N=7)
• Colorectal Carcinoma MSH2 loss (N=15)
• Colorectal Carcinoma MSH6 loss (N=15)

Specific Requirements

• Any stage; Any subtype
• Tumor % ≥ 25%
• Necrosis % < 40%
• Minimum Slide Yield: 50 cuts

Associated Data Required

• Age, Gender
• Year of collection
• Site/origin of tissues
• Pathology diagnosis
• If primary or metastatic tumor
• Tumor stage, grade

IO-9

Disease

Immune checkpoint inhibitor treatment

• Late Stage Metastatic Melanoma (MM)

Type and Number of Samples

• Retrospective
• FFPE blocks - 20 subjects

Specific Requirements

• Subjects with failed multiple lines of treatment (immune checkpoint inhibitor treatment failure preferred)
• Samples from biopsies or surgical resections
• Samples from primary or secondary (e.g. metastatic) tumors
• Tumor content ≥ 30%
• Necrosis ≤ 30%
• Tissue samples fixed in 10% Neutral Buffered Formalin (NBF)

Associated Data Required

• Age, Gender
• Sample Site (primary or secondary site)
• Sample collection site (e.g. skin, brain, lung, liver)
• Year of collection
• Histological subtype
• Tumor stage and grade
• % tumor and % necrosis per sample
• Patient treatment history

IO-10

Disease

Immune checkpoint inhibitor treatment

• Non-Small-Cell Lung Carcinoma (NSCLC)

Type and Number of Samples

• Retrospective
• FFPE Slides - 20 subjects
• Group 1: Non-responders to immunotherapy (n=10)
• Group 2: Non-responders to EGFR kinase inhibitor treatment (n=10)

Specific Requirements

• Subjects with high expression of PD-L1 (≥ 50% positive tumor cells) as per IHC analysis
• Samples from core needle biopsies or surgical resections
• Tissue samples fixed in 10 % Neutral Buffered Formalin (NBF)
• Group 1: Non-responders to anti-PD-1/PD-L1 drugs (i.e. Opdivo®, Keytruda®, Tecentriq®, Imfinzi® or Libtayo®)
• Group 2: Non-responders to EGFR kinase inhibitors (i.e. Tagrisso®, Iressa®, Tarceva®, Gilotrif®, Conmana®)

Associated Data Required

• Age, Gender
• Year of collection
• Pathological diagnosis with microscopic description (histological subtype)
• Tumor stage and grade
• Treatment history and medical outcome post-therapy
• PD-L1 expression (IHC) data, if applicable

IO-11

Disease

Patients Responders to IO treatment

• Head and Neck Squamous Cell Carcinoma (HNSCC)

Type and Number of Samples

• Retrospective
• FFPE sections - 3 subjects
• Per subject: 5 sections of 5 µm, 10 mm2 surface area
• Per subject: H&E stained image matching the slide set

Specific Requirements

• Subjects must be treated with any immune checkpoint blockade monoclonal drugs (e.g. nivolumab, pembrolizumab etc.)
• Subjects must be responding to anti PD1 treatment (i.e. partial response or complete response)
• Biopsies or resection tissue samples fixed in 10% Neutral Buffered Formalin (NBF)
• Tissue collected prior to anti-PD1 treatment

Associated Data Required

• Age, Gender
• Year of collection
• Pathological diagnosis with microscopic description (Histological Subtype)
• Tumor Stage and Grade
• Site of primary tumor
• Treatment history and medical outcome post-immunotherapy (RECIST)
• Patient Medical History, Medications

LC-02

Disease

Lung Cancer

• Squamous cell lung carcinoma
• Primary lung adenocarcinoma

Type and Number of Samples

• Tissue Microarrays (TMA); total of 1000 subjects
• Squamous cell lung carcinoma (Stages I to IV) : 340 subjects
• Primary lung adenocarcinoma (Stages I to IV): 660

Specific Requirements

• Retrospective
• Main TMA: Adenocarcinioma : 2 cores at the center of tumour + 2 cores at tumour margin including inflammatory cells if observed. For each patient the first 2 cores (600 microns) punched at center + margin have to be placed near each together. Squamous cell lung carcinoma : 3 cores at the center of the tumour
• 2nd MTA block (Replicates): Random location to differ from main block
• General Specification for each TMA: 60-70 cores per TMA. Each core is 0.6mm TMAs prepared for each type of cancer and stage. 30 patients per TMA

Associated Data Required

• Age, Gender
• Diagnostic and medical data
• Stage (TNM, grade), % tumor cells in sample
• Smoking status
• Clinical history including Disease-free survival, Overall survival

LC-12

Disease

Lung Cancer

• Non-Small Cell Lung Carcinoma
• Metastatic

Type and Number of Samples

• Retrospective
• Whole Blood, 11 subjects

Specific Requirements

• Stage IV NSCLC subjects
• Chemotherapy naïve Donors

Associated Data Required

• Age, Gender
• Diagnostic and medical data
• Stage (TNM, grade)
• Medical History and medical out-come

LC-17

Disease

Lung Cancer

• Non-Small Cell Lung Carcinoma
• EGFR mutation positive

Type and Number of Samples

• Prospective
• Plasma, 50 subjects

Specific Requirements

• Patient previously treated or still treated with EGFR Tyrosine Kinase Inhibitor e.g. Gefitinib or Erlotinib
• Responders or non-responders
• Patients treated by TAGRISSO™(Osimertinib) were excluded
• First line or second line of treatment

Associated Data Required

• Age, Gender
• Sample collection date
• Comprehensive pathology and clinical characteristics records
• Smoking history
• Treatment history

LC-18

Disease

Lung Cancer

• Small Cell Lung Cancer (SCLC)

Type and Number of Samples

• Retrospective
• FFPE Blocks, 175 subjects

Specific Requirements

• Stage I to IV
• Primary tumors and secondary tumors

Associated Data Required

• Age, Gender, Ethinicity
• Sample collection date
• Pathological diagnosis with microscopic description
• Tumor stage and grade
• Origin/site of tumor
• Patient Medical History

LC-20

Disease

Lung Cancer

• Non-Small-Cell Lung Carcinoma (NSCLC)
• Adenocarcinoma

Type and Number of Samples

• Retrospective
• FFPE Blocks, 15 subjects
• FFPE Blocks and Matched Plasma, 5 subjects

Specific Requirements

• Patients non-responders or progressors after 2 lines of standard of care (SOC) for the treatment of NSCLC (chemotherapy or biological therapy
• Radiotherapy was excluded as line of treatment accepted
• Biopsies or surgical resections

Associated Data Required

• Age, Gender
• Sample collection date
• Histopathological diagnosis
• TNM stage
• Description of treatment (e.g. chemotherapy protocol or checkpoint inhibitor therapy protocol)
• Treatment history with chronology of treatments and sample collection (i.e. whether sample has been collected before or after treatment)
• Treatment outcome

LC-21

Disease

Lung Cancer

• Non-Small Cell Lung Carcinoma (NSCLC)
• Adenocarcinomas and Squamous cell carcinomas

Type and Number of Samples

• Prospective
• Matched sets of: Flash frozen tumor tissue, Plasma and Whole Blood
• 20 subjects

Specific Requirements

• Biopsy
• Stage I
• Treatment naïve subjects

Associated Data Required

• Age, Gender, Ethinicity
• Sample collection date
• Subject Height (cm) and Weight (kg)
• Diagnosis (cancer type and histological subtype)
• Type of procedure used to obtain definitive diagnosis (e.g. FNA, open lung biopsy surgery)
• Type of procedure used to obtain definitive diagnosis (e.g. FNA, open lung biopsy surgery)
• TNM and stage
• Treatment history
• Mutation/hormonal status when data is available

LC-22

Disease

Lung Cancer

• Non-Small Cell Lung Carcinoma (NSCLC) and Small Cell Lung Cancer (SCLC)

Type and Number of Samples

• Prospective
• Plasma, 150 subjects

Specific Requirements

• Subjects that did not yet undergo any surgery, chemotherapy, radiation or any other treatment for this cancerous lesion (including, but not limited to systemic therapies)
• Recent cancer staging should be within 90 days prior to baseline visit.
• All stages

Associated Data Required

• Age, Gender, Ethinicity
• Sample collection date
• Height (cm) and Weight (kg)
• Diagnostic method (Screening program/Symptoms suggestive of cancer/Following incidental findings/Other-specify)
• Smoking status
• CBC (Complete Blood Count), Hemoglobin level (g/dL), Mean Corpuscular Volume (MCV), Ferritin level
• Existing comorbidity (yes or no): Chronic kidney disease, Renal failure, Cirrhosis (if yes – what is the reason? Alcohol, HBV, HCV), Diabetes, COPD, Autoimmune disease (if yes – which?)
• Family history (cancer in first and second degree relatives)
• Diagnosis – disease type and subtype
• TNM and stage
• Location of metastases (if any)

LC-23

Disease

Lung Cancer

• Non-Small Cell Lung Carcinoma (NSCLC)

Type and Number of Samples

• Retrospective
• FFPE blocks Matched blocks from pre- and post-treatment, 10 sets

Specific Requirements

• All subtypes and all stages
• Primary tumors only
• Both primary and/or metastatic tumors accepted for post-treatment FFPE blocks
• Minimum tumor content: 30%

Associated Data Required

• Age, Gender
• Diagnosis with histopathological subtype
• Date of pre-treatment biopsy/resection
• Date of post-treatment biopsy/resection
• TNM amd stage
• Treatment history

GI-2

Disease

Colorectal Cancer

Type and Number of Samples

• Prospective
• FFPE Blocks and Matched Plasma, 200 subjects

Specific Requirements

• Newly Diagnosed patients with Colorectal Cancer stage IV
• Known KRAS mutation status
• Blood samples collected before treatment

Associated Data Required

• Age, Gender
• Stage (TNM, grade)
• KRAS mutation status
• Treatment History and medical out-come

GI-5

Disease

Gastric Cancer

• Poorly cohesive carcinoma and Normal Adjacent Tumor

Type and Number of Samples

• Retrospective
• Frozen Tissue, 50 subjects

Specific Requirements

• Sample weight > 0.5g
• Sample collected before neoadjuvant therapy or radiotherapy

Associated Data Required

• Age, Gender, Ethinicity
• Sample collection date
• Weight, height, BMI
• Histologic type, Histologic grade, Pathologic staging (TNM)
• Demographic, diagnostic and medical data

GI-7

Disease

Adenocarcinoma of the Esophagogastric Junction

Type and Number of Samples

• Retrospective
• FFPE Blocks, subjects

Specific Requirements

• Stage IIIB or higher

Associated Data Required

• Age, Gender
• Diagnostic and medical data
• Stage (TNM, grade)

GI-19

Disease

Hereditary non-polyposis colorectal cancer (HNPCC)

• Lynch syndrome

Type and Number of Samples

• Retrospective
• FFPE Blocks, 10 subjects

Specific Requirements

• Confirmed loss of MSH6 expression
• Any stage, Any grade, Any histological subtype
• Resections only
• Primary tumors only
• Treated and untreated subjects

Associated Data Required

• Age, Gender
• Year of collection
• Histological subtype
• Tumor Stage (TNM) and Grade
• Method used for confirmation of MSH6 loss of expression

GI-20

Disease

Colorectal Cancer (CRC)

• Esophageal Cancer
• Gastric Cancer

Type and Number of Samples

• Prospective
• EDTA plasma, 50 subjects

Specific Requirements

• Primary or recurrent cancer
• Subjects who did not yet undergo any surgery, chemotherapy, radiation or any other treatment for this cancerous lesion (including, but not limited to systemic therapies)
• Recent cancer staging should be within 90 days prior to baseline visit.

Associated Data Required

• Age, Gender, Ethinicity
• Sample collection date
• Height (cm), Weight (kg)
• Method of diagnosis (Screening program/Symptoms suggestive of cancer/Following incidental findings/Other-specify)
• Smoking status
• CBC (Complete Blood Count), Hemoglobin level (g/dL), Mean Corpuscular Volume (MCV), Ferritin level
• Presence of comorbidity: Chronic kidney disease, Renal failure, Cirrhosis (if yes – what is the reason? Alcohol, HBV, HCV), Diabetes, COPD, Autoimmune disease (if yes – which?)
• Family history of cancer

GI-22

Disease

Cholangiocarcinoma (CC) (intra-hepatic (IHCC) and/ or extra- hepatic (EHCC))

• Ampullary Papilla Cancer (APC)
• Gallbladder Cancer (GBC)
• Adenocarcinoma

Type and Number of Samples

• Retrospective
• FFPE Blocks, 202 subjects

Specific Requirements

• Any stage, Any grade
• Resections
• Primary tumors and secondary tumors (i.e. metastatic) tumors from bile duct, gallbladder, or ampulla of Vater
• Treated and/or untreated patients
• Minimum tumor content ≥ 30%, Maximum necrosis ≤ 10%

Associated Data Required

Pathological diagnosis with microscopic description (Histological Subtype)

• Age, Gender
• Year of collection
• Pathological diagnosis with microscopic description (Histological Subtype)
• Tumor Stage and Grade
• Site of primary, or secondary tumor (if applicable)