Recruiting

Blood Based Biomarkers

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT03334708

Conditions

Pancreatic Cancer

Pancreatic Diseases

Pancreatitis

Pancreatic Cyst

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Blood Draw

Tumor Tissue Collection

Cyst Fluid

Study Details

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.

Conditions

Pancreatic Cancer

Pancreatic Diseases

Pancreatitis

Pancreatic Cyst

Study ID

NCT03334708

Start date

Oct 30, 2017

Status verified date

Aug, 2026

Completion date

Oct 30, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 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 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 Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1: Advanced PDAC cohort

Blood and sweat samples will be drawn from patients prior to starting treatment. A research biopsy may be performed for tissue analysis (ATAC-Array) (optional). This cohort is actively accruing.

Cohort 2: Operable PDAC cohort

Blood samples will be drawn from patients prior to operation. Tissue from surgical sample may be analyzed (ATAC-Array) (optional). This cohort is actively accruing.

Cohort 3: Acute Benign Pancreatic Pathology Cohort

Blood samples will be drawn during acute episode of disease and every 6 to 12 months thereafter, per institutional guidelines. This cohort is closed to accrual.

Cohort 4: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts

Blood samples will be drawn at study enrollment and every 6 to 12 months thereafter, per institutional guidelines. This cohort is closed to accrual.

Cohort 5: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts

Blood samples will be drawn at study enrollment and every 6 to 12 months thereafter, per institutional guidelines. This cohort is closed to accrual.

Cohort 6: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts

Blood samples will be drawn at study enrollment and every 6 to 12 months thereafter, per institutional guidelines. This cohort is closed to accrual.

Cohort 7: Healthy Controls

Blood samples will be collected at study enrollment only. This cohort is closed to accrual.

Interventions

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.

Tumor Tissue Collection

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

Cyst Fluid

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

Primary outcome measure

  • Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Kenneth Yu, MD

646-888-4188yuk1@mskcc.org

David Kelson, MD

646-888-4179

Locations

Memorial Sloan Kettering Monmouth (All protocol activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Kenneth Yu, MD, M.Sc.

646-888-4188

Memorial Sloan Kettering Bergen (All protocol activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Kenneth Yu, MD, M.Sc.

646-888-4188

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

Recruiting

Commack, New York, United States, 11725

Contacts

Kenneth Yu, MD, M.Sc.

646-888-4188

Memorial Sloan Kettering Westchester (All protocol activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Kenneth Yu, MD, M.Sc.

646-888-4188

Memorial Sloan - Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

Contacts

Kenneth Yu, MD

646-888-4188

Memorial Sloan Kettering Basking Ridge (All protocol activities)

Recruiting

New York, New York, United States, 10065

Contacts

Kenneth Yu, MD, M.Sc.

646-888-4188

Memorial Sloan Kettering Nassau (All protocol activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Kenneth Yu, MD, M.Sc.

646-888-4188

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • 17-257

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-14.