Genetic Study of Families With High Frequency of Hodgkin Lymphoma

NCT ID: NCT02795013

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-17
• Study Completion Date: 2018-02-27

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.

Detailed Description

This study entails a clinical interview and submission of a peripheral blood or saliva sample for non-tumor DNA. Participants diagnosed with HL at outside institutions will be requested to sign a release form to allow the outside institution to send their pathology report confirming their HL diagnosis. If available, previously banked tumor tissue samples will be utilized to assess genetic alterations related to HL. Detailed history will be obtained (e.g., demographics, environmental exposures, cancer risk factors, and family pedigree) to facilitate the analysis of phenotype-genotype correlations, taking into account potential confounding factors.

Investigators will examine the germline and possibly the tumor DNA of each individual participant and use the data from all participants to determine if a gene change is related to HL.

Conditions

Hodgkin Lymphoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with Hodgkin Lymphoma

Those with a confirmed diagnosis of Hodgkin Lymphoma (HL) and family members who consent and enroll in this study.

No interventions assigned to this group

Family Members without Hodgkin Lymphoma

Those unaffected by HL will serve as a control group to compare with those with HL.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HudsonAlpha Institute for Biotechnology

OTHER

Sponsor Role: collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jamie Flerlage, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Countries

United States

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

FAMHL

Identifier Type: -

Identifier Source: org_study_id