Pancreatic Neoplasm Clinical Trial
— CAPS 3Official title:
Screening for Early Pancreatic Neoplasia
NCT number | NCT00438906 |
Other study ID # | NA_00005455 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 2006 |
Est. completion date | December 2009 |
Verified date | June 2021 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Lustgarten Foundation, National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the diagnostic yield of screening high risk patients | 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. | 1 year |
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