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NCT04860453 · ClinicalTrials.gov registry record
Genomic Analysis of Families With a History of Discordant Cancers
A clinical trial of Discordant Cancers, sponsored by Case Comprehensive Cancer Center.
- Recruiting
- Registry status
- 150
- Enrollment target
- 1
- Study location
NCT04860453: Recruiting study of Discordant Cancers, sponsored by Case Comprehensive Cancer Center.
NCT04860453 is a study of Discordant Cancers that is actively recruiting participants, run by Case Comprehensive Cancer Center. The registered enrollment target is 150 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04860453, a study of Discordant Cancers, is actively recruiting participants, sponsored by Case Comprehensive Cancer Center.
- RECRUITING
- Registry status
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to identify novel gene mutations which have contributed to significant personal and family history of cancer. Adults with and without cancer will be accrued to the study. Participants qualify to take part in this research study because someone in their family has been diagnosed with or because they themselves have a cancer diagnosis. Participants' DNA and other clinical information will be obtained from a blood sample in order to study the genetic basis of cancer and related complications. All portions in the DNA that code for proteins (i.e., the exome) will be studied. Participant DNA sample and information about family structure and family medical history and ethnic origin may also be collected to better understand this information. Clinical information will be stored and biological samples, including DNA, will be kept for up to three (3) years after collection for future. Ultimately, once identified, the role of the specific genetics changes in the development of inherited cancer(s) will be characterized.
Primary Outcome
Number of participants with a family history of 5 or more discordant cancers that have monogenic germline variants identifiable with WES sequencing The diagnostic yield of monogenic germline variants will be calculated as the discovery rate for a monogenic pathogenic variant within each category (ie 10 pathogenic variants / 30 families = 33% yield rate). A 2-way ANOVA will be performed, with the null hypothesis being that "family history supportive of a known syndrome versus discordant cancers
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Blood Draw
- GENETIC WES via Illumina NextSeq 550 sequencing system
- DIAGNOSTIC_TEST Skin biopsy
- DIAGNOSTIC_TEST Saliva Sample
Study Locations (1)
Ohio
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2020-11-17 |
| Est. Completion | 2028-07-01 |
What NCT04860453 shows while recruiting
NCT04860453 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Discordant Cancers appearing as the primary indexed condition, and to 4 interventions - of which Blood Draw is the first listed.
NCT04860453 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04860453 about?
NCT04860453 is a clinical study titled "Genomic Analysis of Families With a History of Discordant Cancers". The purpose of this study is to identify novel gene mutations which have contributed to significant personal and family history of cancer. Adults with and without cancer will be accrued to the study. Participants qualify to take part in this research study because someone in their family has been di...
What is the current status of trial NCT04860453?
This trial is currently recruiting. The enrollment target is 150 participants. The study started on 2020-11-17. Estimated completion is 2028-07-01.
What conditions does trial NCT04860453 study?
This clinical trial studies the following conditions: Discordant Cancers.
What interventions are being tested in trial NCT04860453?
The interventions under investigation include: Blood Draw (DIAGNOSTIC_TEST), WES via Illumina NextSeq 550 sequencing system (GENETIC), Skin biopsy (DIAGNOSTIC_TEST), Saliva Sample (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04860453?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04860453 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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