Actively Recruiting
Development of Biomarkers for the Early Detection, Surveillance and Monitoring of Pancreatic Ductal Adenocarcinoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-12-02
700
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
S
Sheba Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the development of a minimally invasive blood test to diagnose pancreatic cancer early and to monitor treatment responses. This observational study focuses on pancreatic ductal adenocarcinoma and also includes participants with various pancreatic conditions and healthy controls to compare biomarker changes. Participants are grouped based on their condition: those with advanced or metastatic pancreatic cancer have blood drawn before treatment, after the first chemotherapy cycle, every 8 to 12 weeks during treatment, and at disease progression. Those with acute pancreatitis provide blood samples at diagnosis and then every 6 to 12 months. Participants with chronic pancreatitis, IPMN, or pancreatic cysts have blood collected every 6 to 12 months, while healthy controls provide a single baseline blood sample. Additional samples include tumor tissue and cyst fluid obtained through planned biopsies. During the study, blood samples are collected up to about 50 ml if safe, with specific limits based on participant weight and hemoglobin levels. Researchers will analyze changes in biomarkers over four years to determine how well the test can identify early pancreatic cancer. Participants may also provide previously collected tissue samples. The study is sponsored by Memorial Sloan Kettering Cancer Center and includes regular assessments aligned with clinical care.
CONDITIONS
Brief Title
A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma for Cohorts 1 and 2
- Planned systemic treatment for advanced pancreatic cancer or planned upfront surgery without pre-operative therapy for operable cancer
- Confirmed diagnosis of acute pancreatitis or other acute pancreatic pathology for Cohort 3
- Confirmed diagnosis of chronic pancreatitis or other non-cystic chronic pancreatic pathology for Cohort 4
- Confirmed diagnosis of IPMN without high risk features for Cohort 5
- Confirmed diagnosis of benign pancreatic cyst for Cohort 6
- Willingness to undergo tumor biopsy and provide permission to obtain banked tumor tissue when applicable
- Hemoglobin level greater than 8 for applicable cohorts
- ECOG performance status between 0 and 2 for applicable cohorts
You will not qualify if you...
- Prior chemotherapy or radiation for pancreatic cancer within last 3 months in localized setting for Cohort 1
- Planned neoadjuvant chemotherapy or radiation therapy for Cohort 2
- Active second malignancy except low grade malignancy for Cohorts 1 and 2
- Active or prior malignancy except prior non-melanoma skin cancer for Cohorts 3, 4, 5, 6, and 7
- IPMN with high risk features or planned resection for Cohort 5
- Known carrier of cancer susceptibility gene or family history concerning for genetic predisposition to cancer for all cohorts
- Any medical or psychiatric condition that may interfere with ability to follow study procedures across all cohorts
- Proven or suspected genetic cancer predisposition for applicable cohorts
- Any medical or psychiatric condition interfering with protocol compliance for all cohorts
- Prior malignancy except non-melanoma skin cancer for healthy controls
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies by cohort
Participants undergo blood draws and tumor or cyst fluid biopsies as part of diagnostic testing, aligned with their clinical care.
1 to multiple visits depending on cohort and clinical schedule
Duration - Up to 4 years
Participants are monitored through periodic blood specimen collections to track biomarkers over time.
Single baseline blood draw for healthy controls; blood draws every 6-12 months for chronic and acute pancreatic pathology cohorts; blood draws pre-treatment, after first chemotherapy cycle, every 8-12 weeks during treatment, and at disease progression for pancreatic cancer cohort
Trial Site Locations
Total: 13 locations
1
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
2
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
3
Cold Springs Harbor Laboratory (Specimen Analysis)
Cold Spring Harbor, New York, United States, 11724
Not Yet Recruiting
4
Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
New York University
New York, New York, United States, 10010
Active, Not Recruiting
7
Memorial Sloan - Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
8
Memorial Sloan Kettering Basking Ridge (All protocol activities)
New York, New York, United States, 10065
Actively Recruiting
9
Weill Cornell Medical Center
New York, New York, United States, 10065
Not Yet Recruiting
10
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
11
Sha'are Zedek Medical Center
Jerusalem, Israel, 91031
Not Yet Recruiting
12
Weizmann Institute of Science
Rehovot, Israel
Not Yet Recruiting
13
Sheba Medical Center
Tel Litwinsky, Israel
Actively Recruiting
Research Team
K
Kenneth Yu, MD
D
David Kelson, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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