Clinical trialNo phase (not a drug trial)Withdrawn
Pancreatic Cancer Screening of High-Risk Individuals in Arkansas
- Outcome
- Stopped earlyLack of funding (Business decision)
- Phase
- No phase (not a drug trial)
- Status
- Withdrawn
- Study type
- Interventional
- Planned start
- November 2015
- Planned end
- 19 July 2019
- Enrollment
- 0 participants
- Sites
- 1
- Primary outcomes
- Detection rate of PC and precancerous lesion
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 29 July 2019
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Brief summary public domain (ClinicalTrials.gov)
100 subjects who have a family history of pancreatic cancer (PC), or known genetic syndromes associated with increased risk of pancreatic cancer, will be followed for five years. This data will be used to determine the pancreatic cancer and precancerous lesion detection rate in High Risk Individuals (HRIs). Subjects may agree to annual imaging and annual biomarkers or to biomarkers only.
Intervention public domain (ClinicalTrials.gov)
Other: Pancreatic Cancer Screening Pathway 1. Screening with imaging and biomarker testing
Intervention public domain (ClinicalTrials.gov)
Other: Pancreatic Cancer Screening Pathway 2. Screening with biomarker testing only
Arm public domain (ClinicalTrials.gov)
Pathway 1 (active comparator): Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 1
Arm public domain (ClinicalTrials.gov)
Pathway2 (active comparator): Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 2
Primary outcome public domain (ClinicalTrials.gov)
Detection rate of PC and precancerous lesion. Time frame: 5 years.
Eligibility public domain (ClinicalTrials.gov)
Inclusion Criteria: * Have a family history of PC as listed below or who have one of the following syndromes: Peutz-Jeghers syndrome - STK11; BRCA 1 and 2; PALB2; ATM; FAMMM / P16; HNPCC (Lynch) / MMR genes; Hereditary pancreatitis - PRSS1 * Individuals with three or more affected blood relatives (1st, 2nd or 3rd degree) * Individuals with two or more affected blood relatives with PC, with at least one affected FDR, should be considered for screening. * Patients with a history of Peutz-Jeghers syndrome should be screened, regardless of family history of PC. * Patients with a known p16 (FAMMM syndrome) with one affected 1st or 2nd degree relative will be considered for screening. * Patients with a known BRCA1 or BRCA2 mutation with one affected 1st or 2nd degree relative should be considered for screening. * Patients with a known PALB2 mutation with one affected family member should be considered for screening. * Patients with a known Mismatch-repair gene-mutation carriers (Lynch syndrome) with one affected family member should be considered for screening. Exclusion Criteria: * Not candidates for surgery
Enrollment public domain (ClinicalTrials.gov)
Enrollment: 0 participants (actual).
Why stopped public domain (ClinicalTrials.gov)
Lack of funding