NCT02402244ClinicalTrials.gov

Project: Every Child for Younger Patients With Cancer

The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study

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En resumen

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.

Observacional75.000 participantes buscados279 centros6 países

Categorías

Oncología67%Nefrología y urología12%Enfermedades raras y genéticas5%Hematología4%Endocrino y metabólico4%Neurología2%Inmunología y reumatología2%Dermatología2%Obstetricia y ginecología2%

Registrado en 1 registro

ClinicalTrials.govNCT02402244Abrir este registro en ClinicalTrials.govSincronizado hace 4 semanas

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2015-03-30; recorded start 2015-11-03
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Whether the study is blinded is not stated in the registry recordNo masking information is recorded
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 183 other studies in this databaseCounted from the lead sponsor named in the record (Children's Oncology Group)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 18 conditions.
Lead sponsor type recorded as: research network.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Allocation not stated in the record
Blinding0/20
Masking not stated in the record
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 278 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEGA

A very large study, international in scope: 75,000 participants (target), run at 279 sites, across 6 countries.

How this score is built

Enrolment40/40
75,000 participants (target)
Site count25/25
278 sites
Country count12/15
6 countries
Planned duration10/10
Planned over about 185 months
Sponsor scale9/10
Children's Oncology Group has led 182 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

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).

Afecciones

Adrenal Gland Pheochromocytoma
Carcinoma In Situ
Central Nervous System Neoplasm
Childhood Immature Teratoma
Childhood Kidney Neoplasm
Childhood Langerhans Cell Histiocytosis
Childhood Mature Teratoma
Congenital Mesoblastic Nephroma
Desmoid Fibromatosis
Ganglioneuroma
Lymphoproliferative Disorder
Malignant Neoplasm
Malignant Solid Neoplasm
Melanocytic Neoplasm
Myeloproliferative Neoplasm
Neoplasm of Uncertain Malignant Potential
Neuroendocrine Neoplasm
Stromal Neoplasm

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	Sin mínimo – 25 Years
Voluntarios sanos	No
Método de muestreo	NON_PROBABILITY_SAMPLE

Población del estudio

Patients with cancer enrolled on COG therapeutic study

Elegibilidad tal como figura en el registro

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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	Observacional
Fase	No indicado en el registro
Asignación	No indicado en el registro
Modelo de intervención	No indicado en el registro
Propósito principal	No indicado en el registro
Enmascaramiento	No indicado en el registro
Inscripción	75.000 participantes buscados

Patrocinador y colaboradores

Children's Oncology Group Patrocinador
National Cancer Institute (NCI) Colaboradores

Grupos e intervenciones

Observational Project AYA Protocol
Patients undergo collection of biospecimen samples (e.g., tissue, blood, bone marrow, plasma, serum, buccal swab, saliva, cerebrospinal fluid, or urine).
Observational 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).

Intervenciones

Otro Cytology Specimen Collection Procedure
Undergo cytology specimen collection
Otro Medical Chart Review
Undergo medical data review

Variables de resultado

Variable de resultado principal
Number of patients who consented to biobanking
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.
Plazo Baseline

Fechas

Fechas
Fecha de inicio	3 de noviembre de 2015 (real)
Finalización principal	31 de diciembre de 2030 (estimada)
Finalización	31 de diciembre de 2030 (estimada)
Primera publicación	30 de marzo de 2015 (estimada)
Última actualización	25 de agosto de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	febrero de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

253 centros están en reclutamiento

Australia

Australia
Centro	Ciudad	Estado o región	Estado
Monash Medical Center-Clayton Campus	Clayton	Victoria	En reclutamiento
John Hunter Children's Hospital	Hunter Regional Mail Centre	New South Wales	En reclutamiento
Women's and Children's Hospital-Adelaide	North Adelaide	South Australia	En reclutamiento
Royal Children's Hospital	Parkville	Victoria	En reclutamiento
Princess Margaret Hospital for Children	Perth	Western Australia	Activo, sin reclutar
Perth Children's Hospital	Perth	Western Australia	En reclutamiento
Sydney Children's Hospital	Randwick	New South Wales	En reclutamiento
Royal Hobart Hospital	Saint Hobart	Tasmania	Suspendido
Queensland Children's Hospital	South Brisbane	Queensland	En reclutamiento
The Children's Hospital at Westmead	Westmead	New South Wales	En reclutamiento

Canada

Canada
Centro	Ciudad	Estado o región	Estado
Alberta Children's Hospital	Calgary	Alberta	En reclutamiento
University of Alberta Hospital	Edmonton	Alberta	En reclutamiento
IWK Health Centre	Halifax	Nova Scotia	En reclutamiento
McMaster Children's Hospital at Hamilton Health Sciences	Hamilton	Ontario	En reclutamiento
Kingston Health Sciences Centre	Kingston	Ontario	En reclutamiento
Children's Hospital	London	Ontario	En reclutamiento
The Montreal Children's Hospital of the MUHC	Montreal	Quebec	En reclutamiento
Centre Hospitalier Universitaire Sainte-Justine	Montreal	Quebec	En reclutamiento
Children's Hospital of Eastern Ontario	Ottawa	Ontario	En reclutamiento
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)	Québec		En reclutamiento
Saskatoon Cancer Centre	Saskatoon	Saskatchewan	Suspendido
Jim Pattison Children's Hospital	Saskatoon	Saskatchewan	En reclutamiento
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont	Sherbrooke	Quebec	En reclutamiento
Janeway Child Health Centre	St. John's	Newfoundland and Labrador	En reclutamiento
Hospital for Sick Children	Toronto	Ontario	Suspendido
British Columbia Children's Hospital	Vancouver	British Columbia	En reclutamiento
CancerCare Manitoba	Winnipeg	Manitoba	En reclutamiento

New Zealand

New Zealand
Centro	Ciudad	Estado o región	Estado
Christchurch Hospital	Christchurch		En reclutamiento
Starship Children's Hospital	Grafton	Auckland	En reclutamiento

Puerto Rico

Puerto Rico
Centro	Ciudad	Estado
HIMA San Pablo Oncologic Hospital	Caguas	Activo, sin reclutar
University Pediatric Hospital	San Juan	En reclutamiento
San Jorge Children's Hospital	San Juan	Activo, sin reclutar

Saudi Arabia

Saudi Arabia
Centro	Ciudad	Estado o región	Estado
King Faisal Specialist Hospital and Research Centre	Riyadh		Suspendido

United States

United States
Centro	Ciudad	Estado o región	Estado
Children's Hospital Medical Center of Akron	Akron	Ohio	En reclutamiento
Albany Medical Center	Albany	New York	En reclutamiento
Presbyterian Hospital	Albuquerque	New Mexico	En reclutamiento
University of New Mexico Cancer Center	Albuquerque	New Mexico	En reclutamiento
Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	En reclutamiento
Texas Tech University Health Sciences Center-Amarillo	Amarillo	Texas	Suspendido
Providence Alaska Medical Center	Anchorage	Alaska	En reclutamiento
C S Mott Children's Hospital	Ann Arbor	Michigan	En reclutamiento
Mission Hospital	Asheville	North Carolina	En reclutamiento
Children's Healthcare of Atlanta - Arthur M Blank Hospital	Atlanta	Georgia	En reclutamiento
Augusta University Medical Center	Augusta	Georgia	En reclutamiento
Children's Hospital Colorado	Aurora	Colorado	En reclutamiento
Rush-Copley Medical Center	Aurora	Illinois	En reclutamiento
Dell Children's Medical Center of Central Texas	Austin	Texas	En reclutamiento
Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland	En reclutamiento
University of Maryland/Greenebaum Cancer Center	Baltimore	Maryland	En reclutamiento
Sinai Hospital of Baltimore	Baltimore	Maryland	En reclutamiento

En el registro figuran 229 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

25 de agosto de 2026
Centro añadido
1 site added (279 total)
278279

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT02402244