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Genomic Analysis for Hereditary Cancer

N/A
Waitlist Available
Led By Anna Mitchell, MD PhD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Affected patient with a family history of 5 or more discordant cancers in unilateral descent within a 3-generation pedigree.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline for an average of 1.5 hours
Awards & highlights

Study Summary

This trial is looking for people with cancer or a family history of cancer to study how cancer is passed down genetically. A blood sample will be taken and the DNA will be studied to see how cancer is passed down.

Who is the study for?
This trial is for adults with a family history of many different types of cancer, known as discordant cancers. Eligible participants include those who meet criteria for hereditary syndrome testing or have at least five different cancers in their family across three generations. Both affected and unaffected members can join if they agree to genetic testing.Check my eligibility
What is being tested?
The study involves Whole Exome Sequencing (WES) using the Illumina NextSeq 550 system, blood draws, skin biopsies, and saliva samples to find new gene mutations linked to cancer. It will analyze DNA from participants with diverse familial cancer backgrounds.See study design
What are the potential side effects?
There are no direct side effects from the interventions being studied since they involve non-invasive and minimally invasive procedures like blood draw, skin biopsy, and saliva collection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My family has a history of 5 or more different cancers over three generations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline for an average of 1.5 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline for an average of 1.5 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diagnostic yield for monogenic germline variants in two arms
Number of gHFI variants
Number of participants with a family history of 5 or more discordant cancers that have monogenic germline variants identifiable with WES sequencing

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Affected participants with 5 or more discordant cancers - WESExperimental Treatment4 Interventions
Affected individuals with a family history of 5 or more discordant cancers in unilateral descent with a 3-generation pedigree will receive SOC CLIA/CAP multicancer panel (DNA collected via blood draw or punch biopsy) to examine monogenic variant diagnostic yield. Eligible participants (families with no mutations and at least 2 affected and 1 non-affected family members) may move forward with WES. Any identified monogenic variants of interest will be sent to an industry partner with CLIA/CAP certification for validation. A 6-month follow-up visit will take place during which variants will be discussed and participants who underwent gHFI variant counting (those who were not considered a gene candidate) will have results explained. Appropriate genetic counselling, recurrence risk, and additional clinical referrals will be made as necessary
Group II: SOC genetic counseling (routine clinical care)Active Control3 Interventions
Affected individuals (cancer) with a family history suggestive of a known hereditary syndrome or meeting NCCN criteria for germline testing will receive SOC CLIA/CAP multicancer panel in order to examine monogenic variant diagnostic yield (retrospective data) This arm would also include prospective participants from the "5 or more discordant cancers" group who DID have a variant identified and therefore did not move on to WES.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood Draw
2006
Completed Phase 4
~2400
Skin biopsy
2018
Completed Phase 4
~950
Saliva Sample
2006
N/A
~6730

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,760 Total Patients Enrolled
Anna Mitchell, MD PhDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Media Library

WES via Illumina NextSeq 550 sequencing system Clinical Trial Eligibility Overview. Trial Name: NCT04860453 — N/A
Discordant Cancers Research Study Groups: Affected participants with 5 or more discordant cancers - WES, SOC genetic counseling (routine clinical care)
Discordant Cancers Clinical Trial 2023: WES via Illumina NextSeq 550 sequencing system Highlights & Side Effects. Trial Name: NCT04860453 — N/A
WES via Illumina NextSeq 550 sequencing system 2023 Treatment Timeline for Medical Study. Trial Name: NCT04860453 — N/A

Frequently Asked Questions

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

Am I suited to join this trial?

"This medical trial is seeking 150 volunteers aged between 18 and 100 who possess a discordant form of cancer. In order to be considered for the study, participants must satisfy additional criteria: Unaffected family members can qualify for WES if a minimum of 2 affected and 1 unaffected kin are willing to partake in the experiment, patients with familial history indicative of an acknowledged hereditary syndrome or meeting NCCN standards for germline testing plus giving their consent to a multicancer panel,-- this group serves as an everyday control cohort obtaining usual standard care and cannot participate in WES., Patients with 5 or more distinct cancers within 3 generations on one side of their"

Answered by AI

Are there any opportunities to join this medical research initiative?

"Unfortunately, clinicaltrials.gov reveals that this research endeavour is not presently enrolling test subjects - the study was initially posted on July 1st 2023 and last updated on February 22nd 2022. Fortunately, there are still other medical trials actively recruiting patients right now."

Answered by AI

Are applicants beyond their 25th year of life being considered for inclusion in this experiment?

"Qualifying for this trial requires that applicants are aged 18 and below the century mark."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Genomic Analysis of Families With a History of Discordant Cancers
2024. "Genomic Analysis of Families With a History of Discordant Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04860453.
~100 spots leftby Jul 2028
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