The Project: Everychild Protocol: A Registry, Eligibility Screening, Biology And Outcome Study
Clinical Trial Information
Trial Contact: El-Shami, Jessica; Francois, Laetitia Claire; Leffin, Melissa; Spinelli, Jennifer
IRB No: APEC14B1
Protocol Abbrev: APEC14B1
Principal Investigator: Vincent F. Giusti, MD
Sub Investigators: AguilarBonilla, Ana MD; Eslin, Don MD; Martin, Rebecca, ARNP; Pope, Michele ARNP; Smith, Amy MD; Story, Allison ARNP; Sullivan Darden, Kelly ARNP; Sutphin, Robert MD; Wieber, Laura ARNP; Levy, Alejandro MD
Age Group: Pediatric
Secondary Protocol No: APEC14B1
ClinicalTrials.gov ID: NCT02402244
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.
3.2 Patient Eligibility Criteria
Important note: The eligibility criteria listed below are interpreted literally and cannot be waived.
For certain COG therapeutic studies, enrollment on APEC14B1 must occur prior to enrollment on the therapeutic trial. This requirement will be stated within the eligibility section of the therapeutic study, when applicable.
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.
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.
Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:
126.96.36.199 All cancer cases with an ICD-O histologic behavior code of two “2” (carcinoma in situ) or three “3” (malignant).
188.8.131.52 All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant.
184.108.40.206 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
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 Informed consent:
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.
If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow. Consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1.