Pancreatic Cancer Screening of High-Risk Individuals in Arkansas

Pancreatic Neoplasms Clinical Trial

Official title:

Pancreatic Cancer Screening of High-Risk Individuals in Arkansas

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02309632
• Other study ID #: 203640
• Status: Withdrawn
• Phase: N/A
• Start date: November 2015
• Est. completion date: July 19, 2019

Study information

• Verified date: July 2019
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 19, 2019
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Ataxia Telangiectasia
• BRCA1 Gene Mutation
• BRCA2 Gene Mutation
• Colorectal Neoplasms
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Dysplastic Nevus Syndrome
• Familial Atypical Mole-Malignant Melanoma Syndrome
• Hereditary Pancreatitis
• Melanoma
• Neoplasms
• Pancreatic Neoplasms
• Pancreatitis
• Pancreatitis, Chronic
• Peutz-Jegher's Syndrome
• Peutz-Jeghers Syndrome
• Skin Neoplasms
• Syndrome
• Telangiectasis

Intervention

Other:
• Pancreatic Cancer Screening Pathway 1
Screening with imaging and biomarker testing
• Pancreatic Cancer Screening Pathway 2
Screening with biomarker testing only

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of PC and precancerous lesion		5 years