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NCT02402244ClinicalTrials.gov

Project: Every Child for Younger Patients With Cancer

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

RecruitingTaking participants now, according to the registry record.
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In brief

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.

Observational75,000 participants sought279 sites6 countries

Categories

Registered in 1 registry

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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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.

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.

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.

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).

Conditions

  • 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

Eligibility

Eligibility
SexAll
AgesNo minimum – 25 Years
Healthy volunteersNo
Sampling methodNON_PROBABILITY_SAMPLE

Study population

Patients with cancer enrolled on COG therapeutic study

Eligibility as written in the registry

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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study typeObservational
PhaseNot stated in the registry record
AllocationNot stated in the registry record
Intervention modelNot stated in the registry record
Primary purposeNot stated in the registry record
MaskingNot stated in the registry record
Enrolment75,000 participants sought

Sponsor and collaborators

  • Children's Oncology Group Sponsor
  • National Cancer Institute (NCI) Collaborators

Arms and interventions

  • 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).

Interventions

  • Other Cytology Specimen Collection Procedure

    Undergo cytology specimen collection

  • Other Medical Chart Review

    Undergo medical data review

Outcome measures

  1. Primary outcome

    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.

    Time frame Baseline

Dates

Dates
Start dateNovember 3, 2015 (actual)
Primary completionDecember 31, 2030 (estimated)
CompletionDecember 31, 2030 (estimated)
First postedMarch 30, 2015 (estimated)
Last updatedAugust 25, 2026
Results postedNot stated in the registry record
Status last verifiedFebruary 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

253 sites are recruiting

Australia

Australia
FacilityCityState or regionStatus
Monash Medical Center-Clayton CampusClaytonVictoriaRecruiting
John Hunter Children's HospitalHunter Regional Mail CentreNew South WalesRecruiting
Women's and Children's Hospital-AdelaideNorth AdelaideSouth AustraliaRecruiting
Royal Children's HospitalParkvilleVictoriaRecruiting
Princess Margaret Hospital for ChildrenPerthWestern AustraliaActive, not recruiting
Perth Children's HospitalPerthWestern AustraliaRecruiting
Sydney Children's HospitalRandwickNew South WalesRecruiting
Royal Hobart HospitalSaint HobartTasmaniaSuspended
Queensland Children's HospitalSouth BrisbaneQueenslandRecruiting
The Children's Hospital at WestmeadWestmeadNew South WalesRecruiting

Canada

Canada
FacilityCityState or regionStatus
Alberta Children's HospitalCalgaryAlbertaRecruiting
University of Alberta HospitalEdmontonAlbertaRecruiting
IWK Health CentreHalifaxNova ScotiaRecruiting
McMaster Children's Hospital at Hamilton Health SciencesHamiltonOntarioRecruiting
Kingston Health Sciences CentreKingstonOntarioRecruiting
Children's HospitalLondonOntarioRecruiting
The Montreal Children's Hospital of the MUHCMontrealQuebecRecruiting
Centre Hospitalier Universitaire Sainte-JustineMontrealQuebecRecruiting
Children's Hospital of Eastern OntarioOttawaOntarioRecruiting
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)QuébecRecruiting
Saskatoon Cancer CentreSaskatoonSaskatchewanSuspended
Jim Pattison Children's HospitalSaskatoonSaskatchewanRecruiting
Centre Hospitalier Universitaire de Sherbrooke-FleurimontSherbrookeQuebecRecruiting
Janeway Child Health CentreSt. John'sNewfoundland and LabradorRecruiting
Hospital for Sick ChildrenTorontoOntarioSuspended
British Columbia Children's HospitalVancouverBritish ColumbiaRecruiting
CancerCare ManitobaWinnipegManitobaRecruiting

New Zealand

New Zealand
FacilityCityState or regionStatus
Christchurch HospitalChristchurchRecruiting
Starship Children's HospitalGraftonAucklandRecruiting

Puerto Rico

Puerto Rico
FacilityCityState or regionStatus
HIMA San Pablo Oncologic HospitalCaguasActive, not recruiting
University Pediatric HospitalSan JuanRecruiting
San Jorge Children's HospitalSan JuanActive, not recruiting

Saudi Arabia

Saudi Arabia
FacilityCityState or regionStatus
King Faisal Specialist Hospital and Research CentreRiyadhSuspended

United States

United States
FacilityCityState or regionStatus
Children's Hospital Medical Center of AkronAkronOhioRecruiting
Albany Medical CenterAlbanyNew YorkRecruiting
Presbyterian HospitalAlbuquerqueNew MexicoRecruiting
University of New Mexico Cancer CenterAlbuquerqueNew MexicoRecruiting
Lehigh Valley Hospital-Cedar CrestAllentownPennsylvaniaRecruiting
Texas Tech University Health Sciences Center-AmarilloAmarilloTexasSuspended
Providence Alaska Medical CenterAnchorageAlaskaRecruiting
C S Mott Children's HospitalAnn ArborMichiganRecruiting
Mission HospitalAshevilleNorth CarolinaRecruiting
Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlantaGeorgiaRecruiting
Augusta University Medical CenterAugustaGeorgiaRecruiting
Children's Hospital ColoradoAuroraColoradoRecruiting
Rush-Copley Medical CenterAuroraIllinoisRecruiting
Dell Children's Medical Center of Central TexasAustinTexasRecruiting
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMarylandRecruiting
University of Maryland/Greenebaum Cancer CenterBaltimoreMarylandRecruiting
Sinai Hospital of BaltimoreBaltimoreMarylandRecruiting

229 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

  1. August 25, 2026

    Site added

    1 site added (279 total)

    278279