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2014-02
2017-02
2017-02
58
NCT02703545
Johns Hopkins University
Johns Hopkins University
OBSERVATIONAL
International CAPS Registry: Pancreas Cancer Cases in Surveillance Programs
Various centers around the world are currently investigating the feasibility and yield of surveillance for pancreatic cancer in high-risk individuals. Evidence is beginning to accumulate that surveillance may lead to the early detection of non-invasive precursor lesions and asymptomatic early stage cancer. Ultimately, the goal of surveillance is to reduce mortality in these high risk individuals, but before this can be confirmed many research questions need to be answered. While the numbers of high-risk individuals screened in each separate screening facility are likely too small to properly address many of these questions, pooling data comprises a sizable sample size providing unique research opportunities. The objective of this study is retrospectively review all cases of high-risk individuals participating in our pancreatic surveillance program in whom 1) a suspicious precursor lesions was detected for which a pancreatic resection was performed and 2) in whom an advanced malignant disease was diagnosed. The de-identified information will be entered into an international multicenter database registry.
The study is a retrospective review of all cases of high-risk individuals participating in our pancreatic surveillance program in whom 1) a suspicious precursor lesions was detected for which a pancreatic resection was performed and 2) in whom an advanced malignant disease was diagnosed. The de-identified information will be entered into an international multicenter database registry.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2015-07-16 | N/A | 2023-11-16 |
2016-03-03 | N/A | 2023-11-18 |
2016-03-09 | N/A | 2023-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Peutz-Jeghers syndrome | |
| : Familial pancreas cancer at least 2 close relatives affected with pancreas cancer on same side of family 1. first degree relative and 1 second degree relative(1st degree link) or 2. first degree relatives or 1 first degree relative and 2 or more second degree relatives | |
| : Germline mutation Carrier 10 % risk BRCA2 mutation carrier with family history of pancreas cancer or, PALB2 mutation carrier or, FAMMM (p16/CDKN2A) mutation carrier | |
| : Germline mutation carrier 5 % risk BRCA1 mutation carrier with family history of pancreas cancer or, HNPCC (Lynch Syndrome) with family history of pancreas cancer or, ATM gene mutation | |
| : Hereditary pancreatitis PRSS1, PRSS2, CTRC gene mutations |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Proportion of patients and resected lesions with pancreatic cancer in situ (high grade dysplasia) or invasive malignancy | Prevalence of pancreatic neoplasia high risk patients who had surgery for detected lesions in screening programs | 5 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Indications for pancreas surgery | Pathology or imagining related to surgery indication | 5 years |
| Proportion of specific types of pancreatic neoplasms by lesion type | 5 years | |
| Incidence of pancreatic in-situ and invasive malignancy after baseline screening | Proportion of patients who had surgery or biopsy for new pancreatic lesions on follow-up | 5 years |
| Calculate all-cause and disease specific mortality | 5 years | |
| Calculate survival time from point of diagnosis and treatment | 5 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
