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RecruitingObservational

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

NCT ID: NCT03334708Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2025-12-02

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.

Arms & interventions

  • Diagnostic TestBlood 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 TestTumor Tissue Collection

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

  • Diagnostic TestCyst Fluid

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

Outcome measures

Primary

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

    Time frame: 4 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: Yes
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 locations (10)

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, 07748

Recruiting
Kenneth Yu, MD, M.Sc. · Contact

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey, 07645

Recruiting
Kenneth Yu, MD, M.Sc. · Contact

Cold Springs Harbor Laboratory (Specimen Analysis)

Cold Spring Harbor, New York, 11724

Not Yet Recruiting
David Tuveson, MD, PhD · Contact

Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities)

Commack, New York, 11725

Recruiting
Kenneth Yu, MD, M.Sc. · Contact

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, 10604

Recruiting
Kenneth Yu, MD, M.Sc. · Contact

New York University

New York, New York, 10010

Active Not Recruiting

Memorial Sloan - Kettering Cancer Center

New York, New York, 10021

Recruiting
Kenneth Yu, MD · Contact

Memorial Sloan Kettering Basking Ridge (All protocol activities)

New York, New York, 10065

Recruiting
Kenneth Yu, MD, M.Sc. · Contact
S · Contact

Weill Cornell Medical Center

New York, New York, 10065

Not Yet Recruiting
David Lyden, MD · Contact

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Centre, New York, 11553

Recruiting
Kenneth Yu, MD, M.Sc. · Contact