Clinical Trials /

Project: Every Child for Younger Patients With Cancer

NCT02402244

Description:

This research trial studies 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.

Related Conditions:
  • Cancer
  • Central Nervous System Neoplasm
  • Desmoid-Type Fibromatosis
  • Langerhans Cell Histiocytosis
  • Lymphoproliferative Disorder
  • Mesoblastic Nephroma
  • Myeloproliferative Neoplasm
  • Teratoma
Recruiting Status:

Recruiting

Trial Eligibility

Document

Title

  • Brief Title: Project: Every Child for Younger Patients With Cancer
  • Official Title: The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study

Clinical Trial IDs

  • ORG STUDY ID: APEC14B1
  • SECONDARY ID: NCI-2014-02057
  • SECONDARY ID: APEC14B1
  • SECONDARY ID: APEC14B1
  • SECONDARY ID: U10CA098543
  • NCT ID: NCT02402244

Conditions

  • Central Nervous System Neoplasm
  • Childhood Immature Teratoma
  • Childhood Langerhans Cell Histiocytosis
  • Childhood Malignant Neoplasm
  • Childhood Mature Teratoma
  • Congenital Mesoblastic Nephroma
  • Desmoid-Type Fibromatosis
  • Lymphoproliferative Disorder
  • Myeloproliferative Neoplasm
  • Stromal Neoplasm

Purpose

This research trial studies 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 biobank 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 bio-specimen samples (e.g., tissue, blood, bone marrow, plasma, serum,
      buccal cells, saliva, cerebrospinal fluid, or urine).
    

Trial Arms

NameTypeDescriptionInterventions
Observational (Project: Every Child)Patients undergo medical data review to create a Childhood Cancer Registry. Patients also undergo collection of bio-specimen samples (e.g., tissue, blood, bone marrow, plasma, serum, buccal cells, saliva, cerebrospinal fluid, or urine).

    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 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
          
    Maximum Eligible Age:25 Years
    Minimum Eligible Age:N/A
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Preservation of clinically annotated, adequately preserved biological specimens for future research efforts
    Time Frame:Baseline
    Safety Issue:
    Description:This protocol is primarily a banking study to facilitate the preservation of clinically annotated, adequately preserved biological specimens for future research efforts.

    Details

    Phase:
    Primary Purpose:Observational
    Overall Status:Recruiting
    Lead Sponsor:Children's Oncology Group

    Last Updated