ClinicalTrials.gov record NCT02402244
Project: Every Child for Younger Patients With Cancer
The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This observational study gathers medical information and collects biospecimens from children, adolescents, and young people diagnosed with cancer to build a registry and biobank. The data and samples may be used to check eligibility or stratify patients for Children's Oncology Group therapeutic trials. Participants (or their parents) may be asked for permission to be contacted about future non-therapeutic research.
What it is studying. The study is collecting clinical records and biological samples (tumor, blood and other tissues) to build a well-annotated childhood cancer registry and biobank and to use those data/samples to screen or stratify patients for therapeutic research.
What the researchers hope to learn. Maintain a childhood cancer registry; develop a well-annotated biorepository of tumor and host samples (including when feasible parental germline DNA); use clinical and biological data to help determine eligibility or stratification for COG therapeutic trials; and allow permission-based future contact for non-therapeutic or prevention research.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- Cytology Specimen Collection Procedure
- Medical Chart Review
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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 one "1" (borderline), 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
- All neoplastic lesions of the kidney 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
- Neuroendocrine tumors including pheochromocytoma
- Melanocytic tumors, except clearly benign nevi
- Ganglioneuromas
- 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
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
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 biorepository 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 permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the patient or their parents (if applicable). V. For patients enrolled through adult cooperative groups, to develop a well annotated adolescent and young adult (AYA) cancer biorepository and to screen for eligibility for current and future research through the collection of biospecimens (at diagnosis, time of progression and time of recurrence), including tumor and host DNA; and key clinical data, including presentation, diagnostic, staging, and summary treatment information. OUTLINE: This is an observational study. Patients are assigned to 1 of 2 protocols. PROJECT: EVERY CHILD PROTOCOL: 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). PROJECT AYA PROTOCOL: Patients undergo collection of biospecimen samples (e.g., tissue, blood, bone marrow, plasma, serum, buccal swab, saliva, cerebrospinal fluid, or urine).
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Medical records will be reviewed to create a childhood cancer registry and key clinical data will be recorded. Biospecimens may be collected at diagnosis, at progression or recurrence, and/or post-mortem — examples include tumor tissue, blood, bone marrow (more invasive), plasma/serum, buccal swab or saliva, cerebrospinal fluid (spinal tap, more invasive), and urine. Samples and data are stored in a biorepository and may be used to screen for eligibility/stratification for therapeutic studies; participants can give permission to be contacted about future non-therapeutic or prevention research. Parents may be asked to provide a separate consent and may be asked to provide their own biospecimens.
How the study is structured. Observational registry study. Participants follow one of two protocols: a Project: Every Child path that includes medical chart review plus collection and storage of biospecimens, or a Project AYA path focused on biospecimen collection. Sample types listed include tissue, blood, bone marrow, plasma, serum, buccal swab, saliva, cerebrospinal fluid, and urine; some sample collection may be invasive (for example bone marrow or spinal fluid) if clinically obtained.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Australia, Canada, New Zealand, Puerto Rico, Saudi Arabia, United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Langerhans cell histiocytosis
Important dates
- Study start
- Nov 3, 2015
- Primary completion
- Dec 31, 2030 (estimated)
- Study completion
- Dec 31, 2030 (estimated)
- Target enrollment
- 75000 participants (estimated)
- Last updated on registry
- Aug 25, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Children's Oncology Group
- Collaborators
- National Cancer Institute (NCI)
Participating sites (279)
- Children's Hospital of AlabamaRecruiting
Birmingham, Alabama, 35233 · United States
- Site Public Contact · 205-638-9285 · oncologyresearch@peds.uab.edu
- Matthew A. Kutny
- USA Health Strada Patient Care CenterRecruiting
Mobile, Alabama, 36604 · United States
- Site Public Contact · 800-388-8721
- Hamayun Imran
- Providence Alaska Medical CenterRecruiting
Anchorage, Alaska, 99508 · United States
- Site Public Contact · 907-212-6871 · AKPAMC.OncologyResearchSupport@providence.org
- Brenda J. Wittman
- Kingman Regional Medical CenterRecruiting
Kingman, Arizona, 86401 · United States
- Site Public Contact · 702-384-0013 · research@sncrf.org
- Alan K. Ikeda
- Banner Children's at DesertRecruiting
Mesa, Arizona, 85202 · United States
- Site Public Contact · 480-412-3100
- Joseph C. Torkildson
- Phoenix Childrens HospitalRecruiting
Phoenix, Arizona, 85016 · United States
- Site Public Contact · 602-546-0920
- Alok K. Kothari
- Banner University Medical Center - TucsonRecruiting
Tucson, Arizona, 85719 · United States
- Site Public Contact · UACC-IIT@uacc.arizona.edu
- Monica M. Davini
- Arkansas Children's HospitalRecruiting
Little Rock, Arkansas, 72202-3591 · United States
- Site Public Contact · 501-364-7373
- Michael W. Bishop
- Kaiser Permanente Downey Medical CenterRecruiting
Downey, California, 90242 · United States
- Site Public Contact · 626-564-3455
- Robert M. Cooper
- City of Hope Comprehensive Cancer CenterRecruiting
Duarte, California, 91010 · United States
- Site Public Contact · 800-826-4673 · becomingapatient@coh.org
- Anna B. Pawlowska
Terms used on this page · explanations by MedicalUpdates.ai
- Enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- Registry
- An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
- written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- biospecimen
- A collection of biological samples, such as blood or tissue, stored with medical information so that researchers can study them later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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