- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04620278
Genetic Investigation of Cancer Predisposition
January 4, 2024 updated by: The University of Texas Health Science Center at San Antonio
Clinical information and samples (blood, saliva, and tumor) will be collected from patients with multiple cancers and/or a family history of cancer as well as from affected and unaffected relatives; samples will be systematically sequenced and evaluated for candidate driver mutations.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Genetic screening will be performed on DNA (and/or RNA) isolated from collected samples from affected individuals by whole exome sequencing or RNA sequencing using in-house pipeline to identify candidate sequence variants.
These variants will be tested for segregation with the phenotype in other relatives (affected/unaffected).
Candidate variants will be subjected to additional downstream analysis, to be guided by the actual type of gene/variant.
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Patricia L Dahia, MD, PhD
- Phone Number: 210-567-4866
- Email: dahia@uthscsa.edu
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229
- University of Texas Health Science Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Individuals with a family history of cancer or with a personal history of multiple cancers that might suggest increased genetic predisposition, but for which an identifiable susceptibility mutation has not been detected.
Description
Inclusion Criteria:
- Any age
Meets at least ONE of the following:
- Personal history (with documented diagnosis) of cancer before the age of 50
- Personal history of more than one primary cancer
- Documented diagnosis of cancer AND family history of that same cancer type or multiple other cancers that do not fit classical criteria of hereditary cancer syndromes
- Documented diagnosis of a rare cancer AND family history of rare cancers that do not fit classical criteria of hereditary cancer syndromes
- There is the same type of cancer in several generations of a family
- Documented diagnosis of multicentric cancers (e.g bilateral cancers in paired organs, or multifocal cancers in single organs) that usually occur as single lesions when presented sporadically
- Early onset cancer (before the age of 50, or breast cancer before age 45) AND family history of early onset cancer Capable of providing access to detailed medical records and family history of cancer
Exclusion Criteria:
- Established genetic diagnosis of a known hereditary cancer syndrome that is compatible with the clinical presentation
- Incarcerated
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Family-Based
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of Rare Genetic Variant
Time Frame: through study completion- approximately 6-12 months
|
Genetic screen detects a mutation that is likely responsible for tumor development
|
through study completion- approximately 6-12 months
|
Identification of somatic (tumor only) mutation
Time Frame: through study completion- approximately 6-12 months
|
Genetic screen detects a mutation that is likely responsible for tumor development
|
through study completion- approximately 6-12 months
|
Identification of Rare Genetic Variant in family members
Time Frame: through study completion- approximately 6-12 months
|
Genetic screen detects a mutation that is likely responsible for tumor development
|
through study completion- approximately 6-12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of clinical spectrum of the disease in families
Time Frame: through study completion- approximately 6-12 months
|
Genetic and clinical analysis reveals clinical features not previously assigned to the disease
|
through study completion- approximately 6-12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Patricia L Dahia, MD, PhD, University of Texas Health at San Antonio
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2024
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
December 1, 2035
Study Registration Dates
First Submitted
November 5, 2020
First Submitted That Met QC Criteria
November 5, 2020
First Posted (Actual)
November 6, 2020
Study Record Updates
Last Update Posted (Estimated)
January 8, 2024
Last Update Submitted That Met QC Criteria
January 4, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC20200666H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All information exchanged between the local investigator/referring physician and the PI will be made through the unique identifiers to maintain patient confidentiality
IPD Sharing Time Frame
Since the age-related penetrance of the disease is not known, it may be many years before an individual changes his/her affection status.
Thus, the clinical updates remain open-ended
IPD Sharing Access Criteria
PI will provide coded data to collaborators who have signed an MTA agreement.
These collaborators will not have access to identifiable data
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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