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Cancer of the Pancreas Screening Study (CAPS 3)

This study has been completed.
Sponsor:
Collaborators:
The Lustgarten Foundation
Information provided by (Responsible Party):
MCanto, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00438906
First received: February 20, 2007
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Pancreatic Neoplasm
Peutz-Jeghers Syndrome
Procedure: Biopsy, Fine Needle Aspiration (FNA)
Drug: Secretin (human synthetic) - ChiRhoClin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for Early Pancreatic Neoplasia

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • To determine the diagnostic yield of screening high risk patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To determine the diagnostic yield of screening high risk patients (defined as relatives of patients with familial pancreatic cancer,patients with familial Peutz-Jeghers syndrome, and patients with germline BRCA2 and p16 mutations) for early pancreatic neoplasia using endoscopic ultrasonography, CT, and MRI/MRCP.


Biospecimen Retention:   Samples With DNA

approx 40 ml of blood, approx 10 ml pancreatic juice, pancreatic cells if fine needle aspirate is clinically recommended


Enrollment: 200
Study Start Date: December 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: 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.
    Drug: 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.
    Other Name: Human Secretin
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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

People at risk for developing pancreatic cancer related to a strong family history of pancreatic cancer or carries a known genetic mutations associated with pancreatic cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438906

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
The Lustgarten Foundation
Investigators
Principal Investigator: Marcia I. Canto, M.D. Johns Hopkins University
  More Information

Additional Information:
No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MCanto, Professor of Medicine and Oncology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00438906     History of Changes
Other Study ID Numbers: 3 P50CA062924-13SB
Study First Received: February 20, 2007
Last Updated: November 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
pancreatic lesions
pancreatic cancer
peutz-jeghers syndrome
BRCA 2 gene mutation
FAMMM/p16
Genes, BRCA2

Additional relevant MeSH terms:
Peutz-Jeghers Syndrome
Syndrome
Neoplastic Syndromes, Hereditary
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Disease
Endocrine Gland Neoplasms
Endocrine System Diseases
Gastrointestinal Diseases
Genetic Diseases, Inborn
Hyperpigmentation
Intestinal Diseases
Intestinal Polyposis
Lentigo
Melanosis
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Pathologic Processes
Pigmentation Disorders
Skin Diseases
Secretin
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014