A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

Conditions

• Pancreatic Cancer
• Pancreatic Cyst
• Pancreatic Diseases
• Pancreatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Blood Draw — DIAGNOSTIC_TEST
  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 — DIAGNOSTIC_TEST
  Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
• Cyst Fluid — DIAGNOSTIC_TEST
  Cyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere

Study Details

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.

Key Dates

First listed

Nov 7, 2017

Start date

Oct 30, 2017

Status verified

Aug 2026

Primary completion

Oct 30, 2026

Completion

Oct 30, 2026

Study Design

Enrollment

120 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: Cohort 7: Healthy Controls
  Blood samples will be collected at study enrollment only. This cohort is closed to accrual.

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

• Kenneth Yu, MD
  646-888-4188
  [email protected]
• David Kelson, MD
  646-888-4179

Locations (10)

Find similar trials in Middletown, NJ

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