An observational study in Pancreatic Cancer, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-06-11.
Sponsored by Columbia University · Observational
The research purpose of this project is to create a registry, and blood and tissue bank for individuals at high-risk for pancreatic cancer. We plan to conduct histopathological and molecular analysis of resected pancreatic tissue prospectively collected from a cohort of pancreatic cancer patients.
Pancreatic cancer is the fifth leading cause of cancer-related death in the United States. In order to improve outcomes of this disease, significant research efforts have focused on understanding the changes that occur in the pancreas prior to tumor occurrence. The types of changes most often associated with tumor have been named pancreatic intraepithelial neoplasia (PanIN). It is not yet clear how to identify the PanIN lesions most likely to develop into cancer and the length of time required for this progression. In order to evaluate these questions, we are interested in examining the microscopic and genetic characteristics of PanIN lesions in two "high-risk" patients: 1) patients who underwent surgery for pancreatic cancer and developed tumor recurrence after surgery and 2) patients with a strong family history of pancreatic cancer or with a genetic syndrome that puts them at risk for pancreas cancer. The surgical specimens from these patients will be evaluated by a pathologist for evidence of widespread PanIN lesions. In addition, PanIN lesions will be tested for abnormalities in several major genes that are known to be important in pancreatic cancer.
2,004 studies on the registry are indexed under Adenocarcinoma; 374 are open to participants now.
This study's enrollment of 5 is below the median of 153 across 332 observational studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
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Patients who are identified by a clinician as having either 1) a strong family history of pancreatic cancer; or 2) evidence (radiological or pathological) of local tumor recurrence following surgical resection, will be included in the study.
Exclusion Criteria:
Patients with a strong family history of pancreatic cancer or with a genetic syndrome that puts them at risk for pancreas cancer.
Patients who underwent surgery for pancreatic cancer and developed tumor recurrence after surgery
Number of subjects with histological features of PanIN lesions assessed
Distinctive histological features of PanIN within surgical specimens of our two study groups will be assessed by pathologists.
Time frame: 1 year
Evaluation of clonality multifocal PanIN lesions
Using microarray-based comparative genomic hybridization (aCGH) to evaluate the samples.
Time frame: 1 year
Evaluation of Recurrence Mechanism in PDC
aCGH will also be utilized to evaluate recurrence mechanism in a set of cases in which both original tumor and recurrence tumor was resected, allowing for clonal origins to be evaluated.
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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