Next Generation Sequencing of Normal Tissues Prospectively in Pediatric Oncology Patients

RecruitingOBSERVATIONAL
Enrollment

2,500

Participants

Timeline

Start Date

August 28, 2015

Primary Completion Date

December 31, 2033

Study Completion Date

December 31, 2038

Conditions
Solid, Liquid, Central Nervous System Tumors
Interventions
OTHER

Study Introduction Visit

Within 5±3 weeks following arrival at SJCRH, or at the participant/family's convenience, participants will meet with a genetic counselor and clinician, provide information for a family pedigree, undergo a physical and discuss germline testing options. Study introduction materials will be provided. Families interested in the G4K study will be referred to the study nurse or other G4K member and an Informed consent visit will be scheduled.

OTHER

Informed Consent Visit

Within 1±3 weeks following the Study Introduction Visit, or at the participant/family's convenience, the research nurse or other study team member will consent the family and collect demographic and medical information. Participants will complete assessment questionnaires.

OTHER

Informed Consent Follow-Up Visit

At or after enrollment but before the release of the gerline results, or at the participant/family's convenience, a subset of participants (30-40) will participate in semi-structured interviews.

OTHER

Return of Results Conversation

Participants will complete the assessment questionnaires.

OTHER

Return of Results Follow-Up Visits

Return of Results Follow-Up Visits will be conducted twice: the first within 8±4 weeks of the Return of Results Conversation, or at the participant/family's convenience, and the second within 28 ± 4 weeks of the Return of Results Conversation or at the participant/family's convenience. At each visit, participants will complete assessment questionnaires. Semi-structured interviews with parents and adolescents will be conducted.

PROCEDURE

Blood Sample

For patients who have not previously provided a blood sample, a sample of blood will be obtained as a source of germline DNA.

PROCEDURE

Skin Biopsy

After consent, for participants with a diagnosis where peripheral blood is likely to be contaminated by tumor cells, skin biopsies may be done as a source of germline DNA.

Trial Locations (1)

38105

RECRUITING

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
lead

St. Jude Children's Research Hospital

OTHER