Screening for Early Pancreatic Neoplasia (Cancer of the Pancreas Screening or CAPS4 Study) (CAPS4)
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ClinicalTrials.gov Identifier: NCT00714701 |
Recruitment Status
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Completed
First Posted
: July 14, 2008
Last Update Posted
: March 22, 2017
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Tracking Information | |||||
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First Submitted Date | July 9, 2008 | ||||
First Posted Date | July 14, 2008 | ||||
Last Update Posted Date | March 22, 2017 | ||||
Study Start Date | June 2008 | ||||
Actual Primary Completion Date | July 2016 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
This clinical study will assess the diagnostic yield of a clinical screening program for early pancreatic neoplasia in high risk individuals. [ Time Frame: 5 years ] | ||||
Original Primary Outcome Measures | Same as current | ||||
Change History | Complete list of historical versions of study NCT00714701 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Outcome Measures | Not Provided | ||||
Original Other Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Screening for Early Pancreatic Neoplasia (Cancer of the Pancreas Screening or CAPS4 Study) | ||||
Official Title | Screening for Early Pancreatic Neoplasia (Cancer of the Pancreas Screening or CAPS4 Study) | ||||
Brief Summary | CAPS4 is a study at Johns Hopkins Hospital to study the diagnosis and long-term outcomes of screening patients with an increased inherited risk for pancreatic cancer. | ||||
Detailed Description | Pancreatic cancer is a deadly disease and the only hope for improvement of survival is early detection. Certain genetic syndromes are associated with a high risk of pancreatic cancer and screening for pancreatic cancer has become a relatively new strategy for familial pancreatic cancer. . Our pancreatic cancer research group at Johns Hopkins and others have shown that screening with EUS and/or abdominal imaging tests such as CT/MRI can detect a relatively high number of significant pancreatic neoplasms (7-18%) in asymptomatic high risk individuals with an inherited predisposition for pancreatic ductal adenocarcinoma This is a clinical, early detection translational study that will directly influence patient care. This long term study follows the successful completion of single center Cancer of the Pancreas (CAPS) 1 and CAPS 2 studies at Johns Hopkins, and the ongoing CAPS 3 multicenter study. GENERAL AIM: This is a study that aims to evaluate the diagnostic yield, quality of life, and clinical outcomes of a clinical screening and surveillance program for individuals at-risk for pancreatic cancer and to validate a candidate panel of biomarkers for early detection of pancreatic neoplasia. The 3 specific groups to be screened and followed are individuals from familial pancreatic cancer kindreds (who have 2 or more affected relatives and have an estimated risk 16-57 times that of controls), patients with familial Peutz-Jeghers syndrome, patients with a known BRCA-2, BRCA-1, PALB2, PRSS or p16 germline mutation. | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description: blood, pancreatic juices |
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Sampling Method | Probability Sample | ||||
Study Population | asymptomatic high risk patients | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
631 | ||||
Original Estimated Enrollment |
240 | ||||
Actual Study Completion Date | July 2016 | ||||
Actual Primary Completion Date | July 2016 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Additional requirements for eligible high risk patients: i) All persons with known genetic mutation must have proof of mutation status. Those who had research-related genetic testing must have confirmation by a clinical CLIA-certified laboratory. ii) A good faith attempt should be made to confirm pancreatic cancers in the family members via registration in a pancreatic cancer registry iii) The affected first degree relative of the person being screened must be confirmed by medical record or death certificate. All control patients must be > 18 and < 80 years old and no personal or family history of pancreatic cancer or a germline mutation linked to pancreatic cancer. Exclusion Criteria: Patients will be excluded if they have any of the following:
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Sex/Gender |
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Ages | 18 Years to 100 Years (Adult, Senior) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT00714701 | ||||
Other Study ID Numbers | J0139 00-04-14-10 J0139 |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Sidney Kimmel Comprehensive Cancer Center | ||||
Study Sponsor | Sidney Kimmel Comprehensive Cancer Center | ||||
Collaborators |
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Investigators |
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PRS Account | Sidney Kimmel Comprehensive Cancer Center | ||||
Verification Date | March 2017 |