NCT02309632

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2019

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2019

Enrollment Period

3.7 years

First QC Date

December 3, 2014

Last Update Submit

July 25, 2019

Conditions

Pancreatic NeoplasmsPeutz-Jegher's SyndromeBRCA1 Gene MutationBRCA2 Gene MutationAtaxia TelangiectasiaFamilial Atypical Mole-Malignant Melanoma SyndromeColorectal Neoplasms, Hereditary NonpolyposisHereditary Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • Detection rate of PC and precancerous lesion

    5 years

Study Arms (2)

Pathway 1

ACTIVE COMPARATOR

Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 1

Other: Pancreatic Cancer Screening Pathway 1

Pathway2

ACTIVE COMPARATOR

Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 2

Other: Pancreatic Cancer Screening Pathway 2

Interventions

Pancreatic Cancer Screening Pathway 1OTHER

Screening with imaging and biomarker testing

Pathway 1
Pancreatic Cancer Screening Pathway 2OTHER

Screening with biomarker testing only

Pathway2

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Not candidates for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsPeutz-Jeghers SyndromeAtaxia TelangiectasiaMelanoma, Cutaneous MalignantColorectal Neoplasms, Hereditary NonpolyposisHereditary pancreatitis

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeoplastic Syndromes, HereditaryIntestinal PolyposisIntestinal DiseasesGastrointestinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLentigoMelanosisHyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue DiseasesSpinocerebellar AtaxiasCerebellar AtaxiaCerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocutaneous SyndromesAtaxiaDyskinesiasNeurologic ManifestationsTelangiectasisVascular DiseasesCardiovascular DiseasesPrimary Immunodeficiency DiseasesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsColonic Diseases

Study Officials

  • Kent D McKelvey, MD

    University of Arkansas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 5, 2014

Study Start

November 1, 2015

Primary Completion

July 19, 2019

Study Completion

July 19, 2019

Last Updated

July 29, 2019

Record last verified: 2019-07

Locations

US(1)