2,500
Participants
Start Date
August 28, 2015
Primary Completion Date
December 31, 2033
Study Completion Date
December 31, 2038
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.
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.
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.
Return of Results Conversation
Participants will complete the assessment questionnaires.
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.
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.
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.
RECRUITING
St. Jude Children's Research Hospital, Memphis
St. Jude Children's Research Hospital
OTHER