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Recruiting NCT03334708

A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

— Observational Pancreatic Cancer Pancreatic Diseases Pancreatitis Pancreatic Cyst

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood Draw, Tumor Tissue Collection, Cyst Fluid.
Who it may be relevant to
Registry conditions: Pancreatic Cancer, Pancreatic Diseases, Pancreatitis, Pancreatic Cyst. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Development of Biomarkers for the Early Detection, Surveillance and Monitoring of Pancreatic Ductal Adenocarcinoma

Overview

The purpose of this study is to develop a minimally invasive test to diagnose pancreatic cancer at early stages of disease and monitor response to treatment.

Interventions

  • Diagnostic test Blood Draw
    If clinically safe, up to approximately 50ml of blood will be drawn, not to exceed the following criteria: Patients and controls weighing 50kg or more * For draw amounts up to 50mL, there is no required hemoglobin threshold. * For amounts exceeding 50mL, patients who meet standard blood banking criteria (e.g., hemoglobin values within normal limits and minimum weight of 50kg) may give as much as a full unit of blood (500mL) at one time or in divided fractions over a 56 day/eight week period.
  • Diagnostic test Tumor Tissue Collection
    Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
  • Diagnostic test Cyst Fluid
    Cyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere

Primary outcome measures

  • Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer [Time frame: 4 years]

Eligibility criteria

Inclusion criteria

Cohort 1: Advanced Pancreatic Cancer Cohort Inclusion Criteria

  • Radiological, histological or cytological confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma by the enrolling institution
  • Patient planning to receive systemic treatment
  • Hemoglobin > 8
  • ECOG performance status 0-2
  • A minimum age of 18 years old
  • Willing to undergo a tumor biopsy
  • Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material).

Cohort 2: Operable Pancreatic Cancer Cohort Inclusion Criteria

  • Radiological, histological or cytological confirmed diagnosis of pancreatic adenocarcinoma by the enrolling institution
  • Patient planned to undergo upfront resection
  • No pre-operative systemic therapy nor chemoradiation therapy planned
  • Hemoglobin > 8
  • ECOG performance status 0-2
  • A minimum age of 18 years old
  • Willing to undergo a tumor biopsy
  • Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material).

Cohort 3: Acute Benign Pancreatic Pathology Control Inclusion Criteria

  • Confirmed diagnosis of acute pancreatitis or other acute pancreatic pathology by the enrolling institution
  • Hemoglobin > 8
  • ECOG performance status 0-2
  • A minimum age of 18 years old

Cohort 4: Chronic Benign Pancreatic Pathology Control Inclusion Criteria

  • Confirmed diagnosis of chronic pancreatitis or other non-cystic chronic pancreatic pathology by the enrolling institution
  • Hemoglobin > 8
  • ECOG performance status 0-2
  • A minimum age of 18 years old

Cohort 5: IPMN Control Inclusion Criteria

  • Confirmed diagnosis of IPMN without high risk features by the enrolling institution
  • A minimum age of 18 years old

Cohort 6: Pancreatic Cyst Control Inclusion Criteria

  • Confirmed diagnosis of benign pancreatic cyst by the enrolling institution
  • A minimum age of 18 years old

Cohort 7: Healthy Control Inclusion Criteria

  • A minimum age of 18 years old

Exclusion criteria

Cohort 1: Advanced Pancreatic Cancer Cohort Exclusion Criteria

  • Prior chemotherapy or radiation therapy for pancreatic cancer within the last 3 months in the localized setting
  • Active second malignancy, unless low grade malignancy
  • Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Cohort 2: Operable Pancreatic Cancer Cohort Exclusion Criteria

  • Neoadjuvant chemotherapy or radiation therapy is planned
  • Active second malignancy, unless low grade malignancy
  • Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Cohort 3: Acute Benign Pancreatic Pathology Control Exclusion Criteria

  • Active or prior malignancy, except prior non-melanoma skin cancer
  • Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
  • Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Cohort 4: Chronic Benign Pancreatic Pathology Control Exclusion Criteria

  • Active or prior malignancy, except prior non-melanoma skin cancer
  • Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
  • Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Cohort 5: IPMN Control Exclusion Criteria

  • IPMN with high risk features or planned resection
  • Active or prior malignancy, except prior non-melanoma skin cancer
  • Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
  • Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Cohort 6: Pancreatic Cyst Control Exclusion Criteria

  • Active or prior malignancy, except prior non-melanoma skin cancer
  • Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
  • Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Cohort 7: Healthy Control Exclusion Criteria

  • Active or prior malignancy, except prior non-melanoma skin cancer
  • Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
  • Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 10 centers
  • Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown
  • Memorial Sloan Kettering Bergen (All protocol activities) — Montvale
  • Cold Springs Harbor Laboratory (Specimen Analysis) — Cold Spring Harbor
  • Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (All protocol activities) — Harrison
  • New York University — New York
  • Memorial Sloan - Kettering Cancer Center — New York
  • Memorial Sloan Kettering Basking Ridge (All protocol activities) — New York
  • … and 2 more centers
Israel · 3 centers
  • Sha'are Zedek Medical Center — Jerusalem
  • Weizmann Institute of Science — Rehovot
  • Sheba Medical Center — Tel Litwinsky

Identifiers

NCT: NCT03334708 · 17-527

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗