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Project: Every Child for Younger Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02402244
Recruitment Status : Recruiting
First Posted : March 30, 2015
Last Update Posted : May 23, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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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.

Condition or disease Intervention/treatment
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 Other: Cytology Specimen Collection Procedure Other: Medical Chart Review

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, buccal swab, saliva, cerebrospinal fluid, or urine).

Study Design
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Study Type : Observational
Estimated Enrollment : 33000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study
Actual Study Start Date : October 26, 2015
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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, buccal swab, saliva, cerebrospinal fluid, or urine).
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Tissue, blood, bone marrow, plasma, serum, buccal swab, saliva, cerebrospinal fluid, urine

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cancer enrolled on COG therapeutic study
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402244


Locations
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Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Douglas Hawkins Children's Oncology Group
More Information
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: 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 )
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: March 2023
Additional relevant MeSH terms:
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Neoplasms
Carcinoma in Situ
Teratoma
Fibromatosis, Aggressive
Nervous System Neoplasms
Central Nervous System Neoplasms
Fibroma
Nephroma, Mesoblastic
Histiocytosis, Langerhans-Cell
Myeloproliferative Disorders
Lymphoproliferative Disorders
Histiocytosis
Bone Marrow Diseases
Hematologic Diseases
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Germ Cell and Embryonal
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Neoplasms by Site
Nervous System Diseases
Neoplasms, Complex and Mixed