Project: Every Child for Younger Patients With Cancer

• ClinicalTrials.gov Identifier: NCT02402244
• Recruitment Status: Recruiting
• First Posted: March 30, 2015
• Last Update Posted: April 16, 2019
• Sponsor: Children's Oncology Group
• 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

• 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

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
• Listed Location Countries: Australia, Canada, New Zealand, Puerto Rico, Saudi Arabia, United States

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