NCT02795013

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 17, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

1.5 years

First QC Date

June 6, 2016

Last Update Submit

September 12, 2018

Conditions

Keywords

Genetic studiesPediatric

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

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, minimal blood, or tumor will be retained for whole exome sequencing.

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jamie Flerlage, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

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

Locations