The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study
- Study HIC#:1512016865
- Last Updated:05/27/2020
This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.
- Start Date04/17/2016
- End Date01/30/2100
Trial Purpose and Description
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.
II. 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 Children's Oncology Group (COG) therapeutic clinical trials.
III. To develop a well annotated childhood cancer biobank 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 deoxyribonucleic acid (DNA); and key clinical data, including presentation, diagnostic, staging, summary treatment, and outcome information, from every child diagnosed with cancer at COG institutions.
IV. 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.
Patients undergo medical data review to create a Childhood Cancer Registry. Patients also undergo collection of bio-specimen samples (e.g., tissue, blood, bone marrow, plasma, serum, buccal cells, saliva, cerebrospinal fluid, or urine).
- Enrollment can occur at any time after disease presentation including at time of disease progression or recurrence; for patients who are to be enrolled on COG therapeutic studies, enrollment on APEC14B1 must occur prior to enrollment onto the therapeutic trial
- Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:
- All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of two "2" (carcinoma in situ) or three "3" (malignant)
- All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant
- Other benign/borderline conditions including:
- Mesoblastic nephroma
- Myeloproliferative diseases including transient myeloproliferative disease
- Langerhan cell histiocytosis
- Lymphoproliferative diseases
- 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 National Clinical Trials Network (NCTN) ) therapeutic study, for whom there is a higher upper age limit
- All patients or their parents or legally authorized representatives must sign a written informed consent; parents will be asked to sign a separate consent for their own biospecimen submission