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Project: Every Child for Younger Patients With Cancer

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ClinicalTrials.gov Identifier: NCT02402244
Recruitment Status : Recruiting
First Posted : March 30, 2015
Last Update Posted : June 23, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date March 25, 2015
First Posted Date March 30, 2015
Last Update Posted Date June 23, 2022
Actual Study Start Date October 26, 2015
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 30, 2020)
Number of patients who consented to biobanking [ Time Frame: Baseline ]
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.
Original Primary Outcome Measures
 (submitted: March 27, 2015)
medical chart review [ Time Frame: Baseline ]
Preservation of clinically annotated, adequately preserved biological specimens for future research efforts
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Project: Every Child for Younger Patients With Cancer
Official Title The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study
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 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).

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tissue, blood, bone marrow, plasma, serum, saliva, cerebrospinal fluid, urine
Sampling Method Non-Probability Sample
Study Population Patients with cancer enrolled on COG therapeutic study
Condition
  • Carcinoma In Situ
  • Central Nervous System Neoplasm
  • Childhood Immature Teratoma
  • Childhood Langerhans Cell Histiocytosis
  • Childhood Mature Teratoma
  • Congenital Mesoblastic Nephroma
  • Desmoid Fibromatosis
  • Lymphoproliferative Disorder
  • Malignant Solid Neoplasm
  • Myeloproliferative Neoplasm
  • Stromal Neoplasm
Intervention
  • Other: Cytology Specimen Collection Procedure
    Undergo cytology specimen collection
  • Other: Medical Chart Review
    Undergo medical data review
Study Groups/Cohorts Observational (Project: Every Child)
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).
Interventions:
  • Other: Cytology Specimen Collection Procedure
  • Other: Medical Chart Review
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 27, 2015)
33000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2025
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 25 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Australia,   Canada,   New Zealand,   Puerto Rico,   Saudi Arabia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02402244
Other Study ID Numbers APEC14B1
NCI-2014-02057 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
APEC14B1 ( Other Identifier: Children's Oncology Group )
APEC14B1 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Children's Oncology Group
Original Responsible Party Same as current
Current Study Sponsor Children's Oncology Group
Original Study Sponsor Same as current
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Douglas Hawkins Children's Oncology Group
PRS Account Children's Oncology Group
Verification Date February 2022