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

Start date

Oct 30, 2017

Status verified

Dec 2025

Primary completion

Oct 30, 2026

Completion

Oct 30, 2026

Study Design

Enrollment

700 participants (estimated)

Arms

• Arm: 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.
• Arm: 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
• Arm: 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.
• Arm: Healthy Control
  For normal controls, blood specimens will be drawn once at study baseline.

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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