Genetic Study of Families With High Frequency of Hodgkin Lymphoma
1 other identifier
observational
27
1 country
1
Brief Summary
Hodgkin lymphoma (HL) is a relatively rare disorder with known familiar aggregation (i.e. HL in more than one child, or parent and child). Because affected individuals in familial HL are genetically related, the existence of such families has long been considered as evidence in support of a genetic basis of HL susceptibility. However, it is largely unknown which genetic variations are responsible for recurring HL in families. Because the effects of genetic variants are likely to be strong in familial HL, identification of such variations will potentially reveal biological pathways critical to the pathogenesis of HL. PRIMARY OBJECTIVE:
- To perform genome-wide sequencing of families with recurring Hodgkin lymphoma cases (affected as well as non-affected family members) to identify potential disease-causing germline genetic variations. SECONDARY OBJECTIVE:
- To describe demographic and clinical features of the affected families.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2016
CompletedFirst Posted
Study publicly available on registry
June 9, 2016
CompletedStudy Start
First participant enrolled
August 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2018
CompletedSeptember 13, 2018
September 1, 2018
1.5 years
June 6, 2016
September 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Germline genetic variations
Whole exome sequencing of affected and unaffected individuals in these families will be performed. Genetic variants potentially related to HL will be identified on the basis of its co-segregation with HL disease status (e.g., unique variants in individuals affected by HL would be considered as risk variants). Family members without HL (regardless of any other history of malignancy) will be considered as control and be compared against members with HL.
Once, within 1 month of enrollment
Study Arms (2)
Participants with Hodgkin Lymphoma
Those with a confirmed diagnosis of Hodgkin Lymphoma (HL) and family members who consent and enroll in this study.
Family Members without Hodgkin Lymphoma
Those unaffected by HL will serve as a control group to compare with those with HL.
Eligibility Criteria
Patients with a confirmed diagnosis of Hodgkin Lymphoma (HL), and family members of the patient, either affected or unaffected by a malignancy.
You may qualify if:
- Patient with HL diagnosed ≤ 21 years of age with a first-degree relative also diagnosed with HL.
- Family members of the patient, either affected or unaffected by a malignancy who agree to participate in the study.
- Research participant or legal guardian, as appropriate, must provide informed consent for this protocol.
You may not qualify if:
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
Biospecimen
Saliva, minimal blood, or tumor will be retained for whole exome sequencing.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie Flerlage, MD
St. Jude Children's Research Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2016
First Posted
June 9, 2016
Study Start
August 17, 2016
Primary Completion
February 27, 2018
Study Completion
February 27, 2018
Last Updated
September 13, 2018
Record last verified: 2018-09