A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

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

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer; Pancreatic Diseases; Pancreatitis; Pancreatic Cyst
• Intervention / Treatment: Diagnostic test: Blood Draw; Diagnostic test: Tumor Tissue Collection; Diagnostic test: Cyst Fluid

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Kenneth Yu, MD; Phone Number: 646-888-4188; Email: yuk1@mskcc.org
• Study Contact Backup: Name: David Kelson, MD; Phone Number: 646-888-4179

Study Locations

• Israel
  • Jerusalem, Israel, 91031
    • Not yet recruiting
    • Sha'are Zedek Medical Center
    • Contact: Ephrat Levy-Lahad, PhD; Phone Number: 646-497-2600
  • Rehovot, Israel
    • Not yet recruiting
    • Weizmann Institute of Science
    • Contact: Avigdor Scherz, PhD; Phone Number: 972 8-934-2111
  • Tel Litwinsky, Israel
    • Recruiting
    • Sheba Medical Center
    • Contact: Talia Golan, MD; Phone Number: 03-5303295
• United States
  • New Jersey
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (All protocol activities)
      • Contact: Kenneth Yu, MD, M.Sc.; Phone Number: 646-888-4188
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (All protocol activities)
      • Contact: Kenneth Yu, MD, M.Sc.; Phone Number: 646-888-4188
  • New York
    • Cold Spring Harbor, New York, United States, 11724
      • Not yet recruiting
      • Cold Springs Harbor Laboratory (Specimen Analysis)
      • Contact: David Tuveson, MD, PhD; Phone Number: 516-367-5246
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities)
      • Contact: Kenneth Yu, MD, M.Sc.; Phone Number: 646-888-4188
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (All protocol activities)
      • Contact: Kenneth Yu, MD, M.Sc.; Phone Number: 646-888-4188
    • New York, New York, United States, 10021
      • Recruiting
      • Memorial Sloan - Kettering Cancer Center
      • Contact: Kenneth Yu, MD; Phone Number: 646-888-4188
    • New York, New York, United States, 10065
      • Not yet recruiting
      • Weill Cornell Medical Center
      • Contact: David Lyden, MD; Phone Number: 212-746-6565
    • New York, New York, United States, 10010
      • Active, not recruiting
      • New York University
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (All protocol activities)
      • Contact: S
      • Contact: Kenneth Yu, MD, M.Sc.; Phone Number: 646-888-4188
    • Rockville Centre, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (All protocol activities)
      • Contact: Kenneth Yu, MD, M.Sc.; Phone Number: 646-888-4188

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Potential research subjects in the PDAC and benign pancreatic disease cohorts will be identified by a member of the patient's treatment team, the principal investigator, or research team at participating institutions. If the investigator is a member of the treatment team, s/he will screen their patients' medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. The investigator will use information provided by the patient and/or medical record to confirm that the patient is eligible and contact the patient regarding study enrollment. Healthy controls will be recruited from patients from outpatient primary care clinics at non-MSK sites and volunteers from which may include the staffs members at collaborating sites.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Locally Advanced or Metastatic Pancreatic Cancer Cohort; For patients with locally advanced or metastatic PDAC, blood will be collected pre-treatment initiation (baseline), after first chemotherapy cycle, every 8-12 weeks while under treatment to coincide with restaging CT scan and at time of disease progression.	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. 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.; Diagnostic test: Tumor Tissue Collection; Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
Acute Benign Pancreatic Pathology Control Cohort; For patients with acute pancreatitis, blood specimens will be drawn at the time of acute pancreatitis and every 6-12 months thereafter	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. 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.; Diagnostic test: Tumor Tissue Collection; Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
Chronic Benign Pancreatic Path,IPMC & Pancreatic Cyst Ctrl; For patients with chronic pancreatitis, IPMN, or cysts, blood specimens will be drawn every 6-12 months.	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. 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.; 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
Healthy Control; For normal controls, blood specimens will be drawn once at study baseline.	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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer	4 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Weill Medical College of Cornell University; Weizmann Institute of Science; Sheba Medical Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: November 1, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Estimated): December 2, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: 17-257
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Cysts; Pancreatitis; Pancreatic Neoplasms; Pancreatic Cyst; Pancreatic Diseases; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 17-527

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No