A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
Development of Biomarkers for the Early Detection, Surveillance and Monitoring of Pancreatic Ductal Adenocarcinoma
Memorial Sloan Kettering Cancer Center
700 participants
Oct 30, 2017
OBSERVATIONAL
Conditions
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
Inclusion Criteria28
- 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).
- 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).
- 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
- 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
- Confirmed diagnosis of IPMN without high risk features by the enrolling institution
- A minimum age of 18 years old
- Confirmed diagnosis of benign pancreatic cyst by the enrolling institution
- A minimum age of 18 years old
- A minimum age of 18 years old
Exclusion Criteria22
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Interventions
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 will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
Cyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03334708