Project: Every Child for Younger Patients With Cancer

  • STATUS
    Recruiting
  • participants needed
    33000
  • sponsor
    Children's Oncology Group
Updated on 24 October 2021
cancer
metastatic disease
carcinoma
bone marrow procedure
langerhans cell histiocytosis
desmoid tumors
nephroblastoma
cytology specimen collection procedure

Summary

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.

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 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, saliva, cerebrospinal fluid, or urine).

Details
Condition Mesoblastic Nephroma, Malignant neoplasm of kidney, Central Nervous System Neoplasms, Aggressive fibromatosis, Carcinoma in Situ, Carcinoma, Lymphoproliferative Disorder, MYELOPROLIFERATIVE DISORDER, Vulvar Dysplasia and Carcinoma, Advanced Malignancies, Myeloproliferative Neoplasms, Malignant Solid Tumor, Malignant Solid Neoplasm, CNS Malignancy, Childhood Langerhans Cell Histiocytosis, Childhood Malignant Neoplasm, Childhood Immature Teratoma, Childhood Mature Teratoma, Stromal Neoplasm, Kidney Cancer, Desmoid Tumors, Renal Cancer, Lymphoproliferative disorders, central nervous system neoplasm, myeloproliferative neoplasm, myeloproliferative disorders, cns tumors, cns tumor, cns neoplasm, central nervous system tumors, central nervous system tumor, lymphoproliferative disease, in situ carcinoma, cancer in situ, malignant central nervous system tumor, central nervous system cancer, stromal tumor, desmoid tumor
Treatment medical chart review, cytology specimen collection procedure
Clinical Study IdentifierNCT02402244
SponsorChildren's Oncology Group
Last Modified on24 October 2021

Eligibility

Yes No Not Sure

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 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
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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