NCT02560896

Brief Summary

Currently, there is no clear legal or ethical guidance about how researchers and IRBs ought to proceed when the research participant in a biobank is deceased and there is clinically relevant information that could be disclosed to family members. This study is designed to test a procedure offering genetic information to family members of research participants who participated in a pancreatic cancer biobank in a Health Insurance Portability and Accountability Act (HIPAA) -compliant design.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2019

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

4.3 years

First QC Date

August 27, 2015

Last Update Submit

June 2, 2023

Conditions

Familial Pancreatic Cancer

Keywords

FamilyHistoryPancreasCancerGenetic

Outcome Measures

Primary Outcomes (1)

  • Uptake of disclosure invitation

    The primary outcome is: relative proportions of individuals who, when offered genetic results of a deceased family member who participated in a biobank study, will decide to learn those results. Uptake will be a binary outcome (Yes/No). We will enumerate the number of invited participants who choose to learn results and who choose not to learn results.

    6 months

Secondary Outcomes (10)

  • Frequency and duration of physical activity

    6 months

  • Frequency and duration of alcohol use

    6 months

  • Current cigarette smoking status

    6 months

  • Quality and amount of sleep

    6 months

  • Frequency of fruit and vegetable consumption

    6 months

  • +5 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Familial Pancreatic Cancer Kindred

Family members and others authorized to receive health information of participants enrolled under Institutional Review Board (IRB) #354-06 and #355-06 who carry one of several known cancer susceptibility genes. * Mentally competent and able to provide informed consent * Able to understand and read English

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Pancreatic carcinoma, familialNeoplasms

Study Officials

  • Gloria Petersen, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2015

First Posted

September 25, 2015

Study Start

August 1, 2015

Primary Completion

November 4, 2019

Study Completion

November 4, 2019

Last Updated

June 6, 2023

Record last verified: 2023-06

Locations

US(1)