IRB Study Number 16-581
Status Recruiting
Institutes Taussig Cancer Institute, Pediatric Institute
Description
OBJECTIVES:
1.1 To maintain a Childhood Cancer Registry1 for infants, children, adolescents, and young adults with cancer.
1.2 To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto COG therapeutic clinical trials.
1.3 To develop a well annotated childhood cancer biorepository for current and future research through the collection of biospecimens (at diagnosis, time of progression, time of recurrence and/or post-mortem), including tumor, host and when feasible parental germline DNA; and key clinical data, including presentation, diagnostic, staging, summary treatment, and outcome information, from every child diagnosed with cancer at COG institutions.
1.4 To allow use of registry data for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the child or their parents.
Inclusion Criteria
3.2.1.1 Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem.
3.2.1.2 Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority.
3.2.2.1 All cancer cases with an ICD-O histologic behavior code of two “2” (carcinoma in situ) or three “3” (malignant).
3.2.2.2 All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant.
3.2.2.3 The following other benign/borderline conditions:
Mesoblastic nephroma
Teratomas (mature and immature types)
Myeloproliferative diseases including transient myeloproliferative disease
Langerhans cell histiocytosis
Lymphoproliferative diseases
Desmoid tumors
Gonadal stromal cell tumors
3.2.3 Subjects must be ≤ 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating NCTN) therapeutic study, for which there is a higher upper age limit.
3.2.4 All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study. Parents will be asked to sign a separate consent for their own biospecimen submission.
