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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

Locations
United States
New Jersey
Memorial Sloan Kettering Monmouth (All protocol activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (All protocol activities)
RECRUITING
Montvale
New York
Cold Springs Harbor Laboratory (Specimen Analysis)
NOT_YET_RECRUITING
Cold Spring Harbor
Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (All protocol activities)
RECRUITING
Harrison
Memorial Sloan - Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Basking Ridge (All protocol activities)
RECRUITING
New York
New York University
ACTIVE_NOT_RECRUITING
New York
Weill Cornell Medical Center
NOT_YET_RECRUITING
New York
Memorial Sloan Kettering Nassau (All protocol activities)
RECRUITING
Rockville Centre
Other Locations
Israel
Sha'are Zedek Medical Center
NOT_YET_RECRUITING
Jerusalem
Weizmann Institute of Science
NOT_YET_RECRUITING
Rehovot
Sheba Medical Center
RECRUITING
Tel Litwinsky
Contact Information
Primary
Kenneth Yu, MD
yuk1@mskcc.org
646-888-4188
Backup
David Kelson, MD
646-888-4179
Time Frame
Start Date: 2017-10-30
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 700
Treatments
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.
Sponsors
Collaborators: Weill Medical College of Cornell University, Sheba Medical Center, Weizmann Institute of Science
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov