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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01102556 |
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Date of registration:
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12/04/2010 |
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Primary sponsor: |
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Public title:
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Pancreatic Cancer Registry for High Risk Individuals
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Scientific title:
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Columbia Pancreatic Cancer Prevention Program Registry and Tissue Bank for High Risk Individuals |
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Date of first enrolment:
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March 2004 |
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Target sample size:
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1000 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01102556 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Harold Frucht, MD |
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Address:
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Telephone:
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212-305-9337 |
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Email:
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Affiliation:
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Name:
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Harold Frucht, MD |
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Address:
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Telephone:
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212-305-9337 |
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Email:
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Affiliation:
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Name:
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Harold Frucht, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Columbia University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- The modified clinical Bethesda criteria for HNPCC, which are as follows: individuals
with 2 HNPCC-associated cancers (colon, endometrial, small bowel, hepatobiliary,
pancreatic, genitourinary, or gastric), including synchronous or metachronous
lesions; individuals with colon cancer and a first degree relative with an
HNPCC-associated tumor and/or colonic adenoma (1 cancer diagnosed at age <45 years
and the adenoma diagnosed at age <40 years); individuals with colon or endometrial
cancer diagnosed at <50 years; individuals with right-sided colon cancer having an
undifferentiated pattern (solid/cribiform) or signet cell histopathology diagnosed at
<45 years; or individuals with adenomas diagnosed at <40 years.
- Those with a personal or family history of other pancreatic cancer associated
syndromes including: Peutz-Jeghers syndrome, familial pancreatic cancer syndrome,
familial breast cancer syndrome associated with BRCA-2 or BRCA-1, hereditary
pancreatitis, familial atypical multiple mole melanoma, and others.
- Patients in a family with a genetically determined cancer predisposition syndrome.
- Patients with a personal history of a gastrointestinal malignancy at age <45 years.
- Individuals at high-risk based on personal or family history, but not related to a
known pancreatic cancer syndrome include the following: those with a personal history
of pancreatic cancer, or a pre-neoplastic pancreatic lesion; those with a family
history of two or more individuals with cancer, at least one of which is reported to
be a gastrointestinal malignancy; a history of early onset (<50 years)
gastrointestinal cancer in the individual or a family member; a history of multiple
primary cancers, at least one of which is a gastrointestinal primary, or a family
member of an individual meeting this criterion.
Exclusion Criteria:
- Inability to obtain informed consent for study enrollment.
- Under the age of 18 years old.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pancreatic Cancer
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Primary Outcome(s)
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Creation of a registry and blood/tissue bank
[Time Frame: 1 year]
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Secondary Outcome(s)
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Improvement in the diagnosis, prevention, detection, and treatment of pancreatic cancer.
[Time Frame: 10 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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