CLINICAL TRIAL / NCT02402244
Project: Every Child for Younger Patients With Cancer
- Observational
- Recruiting
- NCT02402244
Contact Information
The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study
This study gathers health information for 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.
PRIMARY OBJECTIVES:
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 biorespository 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.
OUTLINE:
Patients undergo medical data review to create a Childhood Cancer Registry. Patients also
undergo collection of biospecimen samples (e.g., tissue, blood, bone marrow, plasma, serum,
buccal swab, saliva, cerebrospinal fluid, or urine).
Gender
All
Age Group
25 Years and under
Accepting Healthy Volunteers
No
Inclusion Criteria:
- 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:
- All cancer cases with an International Classification of Diseases for Oncology
(ICD-O) histologic behavior code of one "1" (borderline), 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
- 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
- Neuroendocrine tumors including pheochromocytoma
- Melanocytic tumors, except clearly benign nevi
- Ganglioneuromas
- 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 which there is a
higher upper age limit
- 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
- Langerhans Cell Histiocytosis