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Trial record 13 of 16 for:    "Peutz-Jeghers Syndrome"

Pancreatic Cancer Screening of High-Risk Individuals in Arkansas

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ClinicalTrials.gov Identifier: NCT02309632
Recruitment Status : Withdrawn (Lack of funding)
First Posted : December 5, 2014
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date  ICMJE December 3, 2014
First Posted Date  ICMJE December 5, 2014
Last Update Posted Date July 29, 2019
Estimated Study Start Date  ICMJE November 2015
Actual Primary Completion Date July 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2014)
Detection rate of PC and precancerous lesion [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02309632 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pancreatic Cancer Screening of High-Risk Individuals in Arkansas
Official Title  ICMJE Pancreatic Cancer Screening of High-Risk Individuals in Arkansas
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Pancreatic Neoplasms
  • Peutz-Jegher's Syndrome
  • BRCA1 Gene Mutation
  • BRCA2 Gene Mutation
  • Ataxia Telangiectasia
  • Familial Atypical Mole-Malignant Melanoma Syndrome
  • Colorectal Neoplasms, Hereditary Nonpolyposis
  • Hereditary Pancreatitis
Intervention  ICMJE
  • Other: Pancreatic Cancer Screening Pathway 1
    Screening with imaging and biomarker testing
  • Other: Pancreatic Cancer Screening Pathway 2
    Screening with biomarker testing only
Study Arms  ICMJE
  • Active Comparator: Pathway 1
    Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 1
    Intervention: Other: Pancreatic Cancer Screening Pathway 1
  • Active Comparator: Pathway2
    Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 2
    Intervention: Other: Pancreatic Cancer Screening Pathway 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 25, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2014)
100
Actual Study Completion Date  ICMJE July 19, 2019
Actual Primary Completion Date July 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02309632
Other Study ID Numbers  ICMJE 203640
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Arkansas
Study Sponsor  ICMJE University of Arkansas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kent D McKelvey, MD University of Arkansas
PRS Account University of Arkansas
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP