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
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Tracking Information | ||||
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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 |
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.
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Original Primary Outcome Measures |
medical chart review [ Time Frame: Baseline ] Preservation of clinically annotated, adequately preserved biological specimens for future research efforts
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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). |
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Study Type | Observational | |||
Study Design | Observational Model: Other Time Perspective: Other |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: Tissue, blood, bone marrow, plasma, serum, saliva, cerebrospinal fluid, urine
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Sampling Method | Non-Probability Sample | |||
Study Population | Patients with cancer enrolled on COG therapeutic study | |||
Condition |
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Intervention |
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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:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Recruiting | |||
Estimated Enrollment |
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:
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Sex/Gender |
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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 ) |
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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 |
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PRS Account | Children's Oncology Group | |||
Verification Date | February 2022 |