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Trial record 86 of 2841 for:    Pancreatic Cancer

International CAPS Registry: Pancreas Cancer Cases in Surveillance Programs (CAPS Registry)

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ClinicalTrials.gov Identifier: NCT02703545
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
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.

Condition or disease
Pancreas Cancer

Detailed Description:
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 58 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: International CAPS Registry: Operated Cases and Cases With Advanced Disease Among High-risk Individuals Participating in a Pancreatic Cancer Surveillance Program; a Case-control Study
Actual Study Start Date : February 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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 :
  1. Proportion of patients and resected lesions with pancreatic cancer in situ (high grade dysplasia) or invasive malignancy [ Time Frame: 5 years ]
    Prevalence of pancreatic neoplasia high risk patients who had surgery for detected lesions in screening programs


Secondary Outcome Measures :
  1. Indications for pancreas surgery [ Time Frame: 5 years ]
    Pathology or imagining related to surgery indication

  2. Proportion of specific types of pancreatic neoplasms by lesion type [ Time Frame: 5 years ]
  3. Incidence of pancreatic in-situ and invasive malignancy after baseline screening [ Time Frame: 5 years ]
    Proportion of patients who had surgery or biopsy for new pancreatic lesions on follow-up

  4. Calculate all-cause and disease specific mortality [ Time Frame: 5 years ]
  5. Calculate survival time from point of diagnosis and treatment [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Familial or genetic pancreas cancer risk cohorts found to have pancreas cancer or pancreas dysplasia
Criteria

Inclusion Criteria:

  • Elevated pancreas cancer risk cohort with pancreas cancer or dysplastic pancreas changes

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703545


Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Marcia I Canto, MD Johns Hopkins University

Additional Information:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02703545     History of Changes
Other Study ID Numbers: IRB00027287
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Keywords provided by Johns Hopkins University:
familial pancreas cancer
pancreatic cyst
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents