Cancer of the Pancreas Screening Study (CAPS 3)

NCT ID: NCT00438906

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2009-12-31

Brief Summary

The purpose of this study is to find the best and most sensitive screening modality (CT, MRI, EUS)for very small pre-cancerous pancreatic lesions and to treat these small lesions before they turn into cancer. Another purpose of this study is to search for common markers on DNA that would increase the chance of someone developing pancreatic cancer, and locate proteins in pancreatic juice that indicate tumor development.

Detailed Description

Pancreatic cancer (PC) is the 4th leading cause of cancer death in the U.S. Because it is seldom diagnosed at an early curable stage, nearly all patients die from their disease. Early detection of PC and its precursors will save lives. In a multi-center, translational prospective controlled cohort study, we propose to screen high-risk individuals (members of familial pancreatic cancer kindreds and/or those with germline mutations of BRCA-2, p16, or STK-11), using EUS, CT, and MRI and test a panel of candidate biomarkers. Patients with suspected neoplasms will be offered surgery and the resected pancreata will be examined by an expert pathologist. Pathological results will be compared with radiologic findings and biomarker results. Our study hypothesis is that screening tests can detect early curable non-invasive pancreatic neoplasia in high risk individuals before it progresses to invasive cancer. The primary specific aim of this study is to determine the frequency of detectable pancreatic neoplasia in individuals with an inherited predisposition for pancreatic cancer. Our additional specific aims are: 1) To test the value of a newly-developed method (PANCPRO) of calculating the risk families have of developing PC so as to best target who might benefit from screening; 2a). To compare performance characteristics and reliability of the pancreatic imaging tests EUS, CT, and MRI/MRCP for the detection of early pancreatic neoplasia; 2b) To determine the prevalence of abdominal and pelvic tumors by CT and MRI in individuals carrying a germ-line BRCA2 gene mutation and patients with Peutz-Jeghers syndrome; 2c) To correlate radiologic abnormalities with histologic findings in resected pancreata; and 3). To validate a panel of candidate DNA and protein markers (CA19-9, macrophage inhibitory cytokine-1 (MIC-1), DNA hypermethylation, and KRAS gene mutations) in pancreatic juice and serum as indicators of prevalent neoplasms in high risk individuals, compared to concurrently enrolled controls.

Conditions

Pancreatic Neoplasm; Peutz-Jeghers Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Biopsy, Fine Needle Aspiration (FNA)

If a pancreatic lesion of concern is identified, a small needle is inserted in the lesion in the pancreas and cells of the lesion are aspirated. Diagnosis of the lesion can typically occur with FNA.

Intervention Type: PROCEDURE

Secretin (human synthetic) - ChiRhoClin

Secretin is a synthetic human hormone that encourages the pancreas to create fluid. This will allow pancreatic juice to be collected via gentle suction in the duodenum where the pancreatic juice naturally flows.

Intervention Type: DRUG

Other Intervention Names

Human Secretin

Eligibility Criteria

Inclusion Criteria

• Persons with a verified family history of 2 or more first degree relatives with primary site pancreatic cancer(PC), age 40-80 years old or if 1 first degree relative also has at least 2 second degree relatives affected with PC.
• Persons with a verified BRCA2 gene mutation or FAMM/p16 gene mutation, age 40-80 years old, and family history of pancreatic cancer.
• Persons with Peutz-Jeghers Syndrome, 30-80 years old, and family history of pancreatic cancer.

Exclusion Criteria

• Persons with pancreatic cancer, or suspicious symptoms.
• Persons who have had pancreas specific imaging protocol performed in the past three years.
• Persons medically unable to have an endoscopy, CT or MRI procedure

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lustgarten Foundation

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcia I. Canto, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

Eshleman JR, Norris AL, Sadakari Y, Debeljak M, Borges M, Harrington C, Lin E, Brant A, Barkley T, Almario JA, Topazian M, Farrell J, Syngal S, Lee JH, Yu J, Hruban RH, Kanda M, Canto MI, Goggins M. KRAS and guanine nucleotide-binding protein mutations in pancreatic juice collected from the duodenum of patients at high risk for neoplasia undergoing endoscopic ultrasound. Clin Gastroenterol Hepatol. 2015 May;13(5):963-9.e4. doi: 10.1016/j.cgh.2014.11.028. Epub 2014 Dec 4.

Reference Type: DERIVED

PMID: 25481712 (View on PubMed)

Kanda M, Sadakari Y, Borges M, Topazian M, Farrell J, Syngal S, Lee J, Kamel I, Lennon AM, Knight S, Fujiwara S, Hruban RH, Canto MI, Goggins M. Mutant TP53 in duodenal samples of pancreatic juice from patients with pancreatic cancer or high-grade dysplasia. Clin Gastroenterol Hepatol. 2013 Jun;11(6):719-30.e5. doi: 10.1016/j.cgh.2012.11.016. Epub 2012 Nov 28.

Reference Type: DERIVED

PMID: 23200980 (View on PubMed)

Related Links

http://www.lustgartenfoundation.org

The Lustgarten Foundation for Pancreatic Cancer provides information for patients and families related to the research, diagnosis, treatment, and prevention of pancreas/pancreatic cancer.

Other Identifiers

NA_00005455

Identifier Type: -

Identifier Source: org_study_id