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NCT Number: NCT03334708

A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

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.

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Key information

Conditions

Pancreatic Cancer Cysts Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Cyst Pancreatic Diseases Pancreatic Neoplasms Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sha'are Zedek Medical Center, Jerusalem, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood draw

Diagnostic Test

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.

Patients and controls weighing < 50kg

  • For patients whose hemoglobin is below normal limits but at least 7.0 gm/dL, no more than a total of 50 ml of blood or 5 ml/kg, whichever is less, may be collected per 56 day/eight week period, but no more than approximately 2 ml/kg of blood at any one time.

Tumor Tissue Collection

Diagnostic Test

Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere

Cyst Fluid

Diagnostic Test

Cyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere

Primary outcomes

  1. Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer

    Time frame: 4 years

Study contacts

Contact information is provided by the study sponsor or research team.

David Kelson, MD

CONTACT

646-888-4179

Kenneth Yu, MD

CONTACT

[email protected]

646-888-4188

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Sheba Medical Center
  • Weill Medical College of Cornell University
  • Weizmann Institute of Science

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2017
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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