Pancreatic Intraepithelial Neoplasia (PanIN) and the Association With Recurrence of Pancreatic Adenocarcinoma
|ClinicalTrials.gov Identifier: NCT01219829|
Recruitment Status : Active, not recruiting
First Posted : October 13, 2010
Last Update Posted : February 8, 2018
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||5 participants|
|Official Title:||Refining the Molecular Progression From Intraductal to Invasive Pancreatic Cancer: Correlating Genetic Profiles and Clinicopathological Phenotypes in Sporadic and Familial Pancreatic Adenocarcinoma|
|Actual Study Start Date :||March 18, 2009|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2020|
Family History patients
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 [ Time Frame: 1 year ]Distinctive histological features of PanIN within surgical specimens of our two study groups will be assessed by pathologists.
- Evaluation of clonality multifocal PanIN lesions [ Time Frame: 1 year ]Using microarray-based comparative genomic hybridization (aCGH) to evaluate the samples.
- Evaluation of Recurrence Mechanism in PDC [ Time Frame: 1 year ]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.
Biospecimen Retention: Samples With DNA
- Blood samples
- Specimens of tumors, pre-cancerous lesions, and normal tissue from patients who need to have endoscopy or surgery for diagnosis or treatment of tumors that develop
- Samples of urine and stool, and duodenal aspirates if an individual will be having an endoscopy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219829
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Wendy K Chung, MD||Columbia University|