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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 : April 16, 2019
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 April 16, 2019
Actual Study Start Date October 26, 2015
Estimated Primary Completion Date December 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 3, 2018)
Preservation of clinically annotated, adequately preserved biological specimens for future research efforts [ Time Frame: Baseline ]
This protocol is primarily a banking study to facilitate the preservation of clinically annotated, adequately preserved biological specimens for future research efforts.
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 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).

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Not Provided
Condition
  • 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
Intervention
  • Other: Cytology Specimen Collection Procedure
    Undergo cytology specimen collection
    Other Name: Cytologic Sampling
  • Other: Medical Chart Review
    Undergo medical data review
    Other Name: Chart Review
Study Groups/Cohorts 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).
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
Study Completion Date Not Provided
Estimated Primary Completion Date December 14, 2020   (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: Childrens 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
Responsible Party Children's Oncology Group
Study Sponsor Children's Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Peter Adamson Children's Oncology Group
PRS Account Children's Oncology Group
Verification Date November 2017