Project: Every Child for Younger Patients With Cancer

Children's Oncology Group

Status: Enrolling

Conditions: Malignant Neoplasm; Lymphoproliferative Disorder; Congenital Mesoblastic Nephroma; Childhood Langerhans Cell Histiocytosis; Desmoid Fibromatosis; Malignant Solid Neoplasm; Central Nervous System Neoplasm; Childhood Kidney Neoplasm; Stromal Neoplasm; Myeloproliferative Neoplasm; Melanocytic Neoplasm; Childhood Immature Teratoma; Neoplasm of Uncertain Malignant Potential; Neuroendocrine Neoplasm; Ganglioneuroma; Carcinoma In Situ; Childhood Mature Teratoma; Adrenal Gland Pheochromocytoma

Treatments: Other: Cytology Specimen Collection Procedure; Other: Medical Chart Review

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT02402244

U10CA098543 (U.S. NIH Grant/Contract)

APEC14B1 (Other Identifier)

NCI-2014-02057 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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 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 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 permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the patient or their parents (if applicable).

V. For patients enrolled through adult cooperative groups, to develop a well annotated adolescent and young adult (AYA) cancer biorepository and to screen for eligibility for current and future research through the collection of biospecimens (at diagnosis, time of progression and time of recurrence), including tumor and host DNA; and key clinical data, including presentation, diagnostic, staging, and summary treatment information.

OUTLINE: This is an observational study. Patients are assigned to 1 of 2 protocols.

PROJECT: EVERY CHILD PROTOCOL: 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).

PROJECT AYA PROTOCOL: Patients undergo collection of biospecimen samples (e.g., tissue, blood, bone marrow, plasma, serum, buccal swab, saliva, cerebrospinal fluid, or urine).

Enrollment: 75,000 estimated patients

Sex: All

Ages: Under 25 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

  • All neoplastic lesions of the kidney 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

Trial design

75,000 participants in 2 patient groups

Observational Project AYA Protocol

Description:

Patients undergo collection of biospecimen samples (e.g., tissue, blood, bone marrow, plasma, serum, buccal swab, saliva, cerebrospinal fluid, or urine).

Treatment:

Other: Cytology Specimen Collection Procedure

Observational Project: Every Child Protocol

Description:

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).

Treatment:

Other: Medical Chart Review

Other: Cytology Specimen Collection Procedure