A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
Development of Biomarkers for the Early Detection, Surveillance and Monitoring of Pancreatic Ductal Adenocarcinoma
1 other identifier
observational
700
2 countries
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2017
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 30, 2017
CompletedFirst Submitted
Initial submission to the registry
November 1, 2017
CompletedFirst Posted
Study publicly available on registry
November 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2026
December 2, 2025
December 1, 2025
9 years
November 1, 2017
December 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer
4 years
Study Arms (4)
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.
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
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.
Healthy Control
For normal controls, blood specimens will be drawn once at study baseline.
Interventions
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 will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
Cyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
Eligibility Criteria
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.
You may qualify if:
- 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).
- 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).
- +13 more criteria
You may not qualify if:
- 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
- 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
- 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
- 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
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Sheba Medical Centercollaborator
- Weill Medical College of Cornell Universitycollaborator
- Weizmann Institute of Sciencecollaborator
Study Sites (13)
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645, United States
Cold Springs Harbor Laboratory (Specimen Analysis)
Cold Spring Harbor, New York, 11724, United States
Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604, United States
New York University
New York, New York, 10010, United States
Memorial Sloan - Kettering Cancer Center
New York, New York, 10021, United States
Memorial Sloan Kettering Basking Ridge (All protocol activities)
New York, New York, 10065, United States
Weill Cornell Medical Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, 11553, United States
Sha'are Zedek Medical Center
Jerusalem, 91031, Israel
Weizmann Institute of Science
Rehovot, Israel
Sheba Medical Center
Tel Litwinsky, Israel
Related Links
Biospecimen
Blood samples will be analyzed for various biomarkers. Initial biomarkers to be tested include proteins and proteases, functional DNA repair assays, exosomes, stromal elements, circular RNAs (cRNA) and circulating tumor DNA (ctDNA). Tissue will be utilized from already planned. Biopsy tissue is expected to be available for virtually all PDAC patients, occasionally for IPMN and cysts patients, rarely for pancreatitis and never for healthy controls.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2017
First Posted
November 7, 2017
Study Start
October 30, 2017
Primary Completion (Estimated)
October 30, 2026
Study Completion (Estimated)
October 30, 2026
Last Updated
December 2, 2025
Record last verified: 2025-12