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Refining the Molecular Progression From Intraductal to Invasive Pancreatic Cancer: Correlating Genetic Profiles and Clinicopathological Phenotypes in Sporadic and Familial Pancreatic Adenocarcinoma


N/A
18 Years
85 Years
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

Refining the Molecular Progression From Intraductal to Invasive Pancreatic Cancer: Correlating Genetic Profiles and Clinicopathological Phenotypes in Sporadic and Familial Pancreatic Adenocarcinoma


Pancreatic adenocarcinoma (PC) is the fourth leading cause of cancer-related death in the
United States.Despite advances in chemotherapeutics and surgical care, the prognosis for PC
patients remains dismal, even following surgery with curative intent. In order to improve
outcomes, the best hope will be to target preinvasive PanIN lesions for screening and
therapy. Prior to this, however, the natural history of PanIN lesions needs to be better
elucidated. A novel model to study PanIN progression is by examination of cases of local
recurrence following surgical resection. We have previously reported our findings from
histopathological review of such cases. Compared to matched controls, locally-recurrent PC
patients were significantly more likely to exhibit a pattern of multifocal, diffuse PanIN in
their original resection tissue. This is similar to the pattern of multifocal PanIN that has
been demonstrated from small prospective screening studies of familial PC kindreds

These analyses support our hypothesis that field carcinogenesis may be an important
mechanism in PC. The objective of our study is to evaluate for pathological and molecular
evidence of a field effect in locallyrecurrent and familial PC. Our first aim is to assess
for distinctive histological features of PanIN within surgical specimens of our two study
groups. Secondly, clonality of multifocal PanIN will be assessed utilizing microarraybased
comparative genomic hybridization (aCGH). Finally, 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.


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Outcome Measure:

Primary Outcome: Distinct histological features of PanIN lesions

Outcome Description:

Our first aim is to assess for distinctive histological features of PanIN within surgical specimens of our two study groups.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Wendy K Chung, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Institutional Review Board

Study ID:

AAAD5381

NCT ID:

NCT01219829

Start Date:

August 2008

Completion Date:

December 2012

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic intraepithelial neoplasia (PanIN)
  • Pancreatic Cancer
  • Recurrence of pancreatic cancer
  • Field Effect
  • Genetic mutations in pancreatic cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms
  • Carcinoma in Situ

Name

Location

Columbia University Medical CenterNew York, New York  10032