Pancreatic Intraepithelial Neoplasia (PanIN) and the Association With Recurrence of Pancreatic Adenocarcinoma

NCT01219829 | Completed DMC

• 1 other identifier: AAAD5381
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic intraepithelial neoplasia (PanIN); Pancreatic Cancer; Recurrence of pancreatic cancer; Field Effect; Genetic mutations in pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (2)

• Evaluation of clonality multifocal PanIN lesions

  1 year

• Evaluation of Recurrence Mechanism in PDC

  1 year

Study Arms (2)

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.

Recurrence patients

Patients who underwent surgery for pancreatic cancer and developed tumor recurrence after surgery

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Tissue-confirmed diagnosis of pancreatic adenocarcinoma.
• Underwent surgical resection for adenocarcinoma at Columbia-Presbyterian Medical Center with pathologically negative surgical margins.
• Enrolled in our Pancreatic Cancer Registry and Tissue Bank protocol (AAAA-6154).
• Have at least 2 relatives (of whom one must be first-degree relative) with pancreatic cancer, or have been diagnosed with a a genetic syndrome which is associated with pancreatic cancer (among the included syndromes include BRCA1/2, FAMMM, Peutz-Jeghers, HNPCC, Hereditary Pancreatitis) -OR- Have radiological or pathological (fine needle aspirate or surgical biopsy) evidence of local tumor recurrence following surgery.

You may not qualify if:

• Metastatic disease discovered at presentation or on recurrence (exception is the familial PDC patients)
• Positive surgical margins.
• Lack of clinical followup at one year following surgery

Sponsors & Collaborators

• Columbia University: lead
• Cold Spring Harbor Laboratory: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

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

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Wendy K Chung, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2010
• First Posted: October 13, 2010
• Study Start: March 18, 2009
• Primary Completion: April 27, 2021
• Study Completion: April 27, 2021
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)