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NCT02402244 · CITED IN SOURCE DOCUMENTS

Project: Every Child for Younger Patients With Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
Not reported
Status at capture
RECRUITING
Registry last update
2026-08-25

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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
healthy Volunteers
false
maximum Age
25 Years
sampling Method
NON_PROBABILITY_SAMPLE
sex
ALL
std Ages
  1. CHILD
  2. ADULT
study Population
Patients with cancer enrolled on COG therapeutic study
Treatment arms and interventions
arm Groups
  1. description
    Patients undergo collection of biospecimen samples (e.g., tissue, blood, bone marrow, plasma, serum, buccal swab, saliva, cerebrospinal fluid, or urine).
    intervention Names
    1. Other: Cytology Specimen Collection Procedure
    label
    Observational Project AYA Protocol
  2. 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).
    intervention Names
    1. Other: Cytology Specimen Collection Procedure
    2. Other: Medical Chart Review
    label
    Observational Project: Every Child Protocol
interventions
  1. arm Group Labels
    1. Observational Project AYA Protocol
    2. Observational Project: Every Child Protocol
    description
    Undergo cytology specimen collection
    name
    Cytology Specimen Collection Procedure
    other Names
    1. Cytologic Sampling
    type
    OTHER
  2. arm Group Labels
    1. Observational Project: Every Child Protocol
    description
    Undergo medical data review
    name
    Medical Chart Review
    other Names
    1. Chart Review
    type
    OTHER
Study design
observational Model
OTHER
time Perspective
OTHER
Enrollment
count
75000
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The number of patients who agree to be in the Biobanking part of the study and have leftover tumor tissue and some normal blood, bone marrow, or other tissue saved for future research.
    measure
    Number of patients who consented to biobanking
    time Frame
    Baseline
Full study description
brief 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.
detailed 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).
Source references
Source notices and limitations
    Discovery and provenance
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        ma using both clinical and molecular criteria. The new criteria will be used in this study. Patients are required to enroll in the COG <a href="/clinicaltrials/NCT02402244">APEC14B1</a> trial and the Molecular Characterization Initiative. Low-risk patients have both fusion-negative and wild-type <em class="gene-name">MYOD1</em> a
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      source string sha256
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      source title
      Childhood Rhabdomyosarcoma Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 11, 2025
        datetime
        2025-04-11T12:00:00Z
        display
        April 11, 2025

    Preserved source evidence · Not medical advice