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Genomic Sequencing for Genetic Predisposition (PopSeq Trial)

N/A

Waitlist Available

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post-disclosure

Awards & highlights

PopSeq Trial Summary

This trial will study how well a process of returning genomic results to patients works and what effects it has.

Who is the study for?

This trial is for adults over 18 who are part of the Framingham Heart Study or Jackson Heart Study, have had their genomes sequenced by TOPMed, and consented to use their DNA for research. It's not open to those who haven't opted in for genomic research or haven't had genome sequencing through TOPMed.Check my eligibility

What is being tested?

The PopSeq Project will give some participants their genomic results (gRoR) and study the medical, behavioral, and economic impacts. It involves interpreting previously sequenced genomes from two heart studies and assessing how genes manifest into physical traits in a group.See study design

What are the potential side effects?

Since this trial involves only receiving genetic information rather than medication or procedures, traditional side effects aren’t expected. However, learning about one’s genetic predispositions could potentially cause anxiety or stress.

PopSeq Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post-disclosure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post-disclosure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-disclosure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Costs of Disclosure

Follow Through with Disclosure

Secondary outcome measures

Guideline Compliance

Health Care Utilization

MD Recommendations

+2 more

Other outcome measures

Decisional Regret

Disclosure-specific Impact

Family Testing

+4 more

PopSeq Trial Design

1Treatment groups

Experimental Treatment

Group I: FHS & JHS participants with an actionable genomic findingExperimental Treatment1 Intervention

Framingham and Jackson Heart Study participants who have had their genomes sequenced as part of TOPMed will be notified if an actionable genetic result in an ACMG v2.0 gene is identified and will be offered the opportunity to have their research result clinically confirmed by the study.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Framingham Heart StudyUNKNOWN

Jackson Heart StudyUNKNOWN

Broad InstituteOTHER

19 Previous Clinical Trials

16,167 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are senior citizens eligible for this trial?

"This trial is for patients aged 18 to 100 years old; however, there are 10 separate studies that cater exclusively to those younger than 18 and 29 focusing on elderly individuals."

Answered by AI

Are there any eligibility criteria for participation in this trial?

"In order to be eligibile for the trial, prospective participants must have a hereditary disposition towards illness and reside between 18-100 years old. The team behind this medical study is seeking 110 individuals in total."

Answered by AI

What are the targeted results of this investigation?

"This clinical trial, which will be evaluated over an 8 month period post-disclosure of genetic results, seeks to analyse the Costs of Disclosure. Secondary goals include measuring Self-Rated Health from SF-12v2 data, MD Recommendations based on chart notes from disclosure sessions and assessing guideline compliance with respect to personal and family history against existing medical guidelines."

Answered by AI

Are new participants being enrolled in this experiment?

"According to the information on clinicaltrials.gov, this trial is not currently taking in new participants. Initially posted June 9th 2021 and last updated a year later, there are alternative medical studies recruiting patients presently."

Answered by AI