A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Nov 2, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new blood test designed to help doctors diagnose pancreatic cancer earlier and to monitor how well treatments are working. The goal is to find a way to detect this disease before it becomes more advanced, which is important because early detection can lead to better treatment outcomes.

To join the study, participants need to be at least 18 years old and have specific types of pancreatic conditions, such as confirmed pancreatic cancer or other benign pancreatic issues. Patients will need to agree to provide a blood sample and, in some cases, a biopsy of their tumor. The trial is currently recruiting participants of all genders, and those interested should speak with their healthcare provider to see if they qualify. It’s important to note that individuals with certain health conditions or prior cancers may not be eligible. If you decide to participate, you’ll be contributing to important research that could improve future pancreatic cancer diagnosis and treatment.

Gender

ALL

Eligibility criteria

• 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