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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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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.

Observationnelle75 000 participants recherchés279 sites6 pays

Catégories

Oncologie67%Néphrologie et urologie12%Maladies rares et génétiques5%Hématologie4%Endocrinien et métabolique4%Neurologie2%Immunologie et rhumatologie2%Dermatologie2%Obstétrique et gynécologie2%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

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

Résumé

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).

Affections

  • 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

Éligibilité

SexeTous
ÂgesAucun minimum – 25 Years
Volontaires sainsNon
Méthode d'échantillonnageNON_PROBABILITY_SAMPLE

Population de l'étude

Patients with cancer enrolled on COG therapeutic study

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeObservationnelle
PhaseNon précisé dans la fiche du registre
RépartitionNon précisé dans la fiche du registre
Modèle d'interventionNon précisé dans la fiche du registre
Objectif principalNon précisé dans la fiche du registre
InsuNon précisé dans la fiche du registre
Recrutement75 000 participants recherchés

Promoteur et collaborateurs

  • Children's Oncology Group Promoteur
  • National Cancer Institute (NCI) Collaborateurs

Groupes et 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

  • Autre Cytology Specimen Collection Procedure

    Undergo cytology specimen collection

  • Autre Medical Chart Review

    Undergo medical data review

Critères de jugement

  1. Critère de jugement 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.

    Délai Baseline

Dates

Date de début3 novembre 2015 (réelle)
Achèvement principal31 décembre 2030 (estimée)
Achèvement31 décembre 2030 (estimée)
Première publication30 mars 2015 (estimée)
Dernière mise à jour25 août 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisfévrier 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

253 sites sont en recrutement

Australia

ÉtablissementVilleÉtat ou régionStatut
Monash Medical Center-Clayton CampusClaytonVictoriaEn recrutement
John Hunter Children's HospitalHunter Regional Mail CentreNew South WalesEn recrutement
Women's and Children's Hospital-AdelaideNorth AdelaideSouth AustraliaEn recrutement
Royal Children's HospitalParkvilleVictoriaEn recrutement
Princess Margaret Hospital for ChildrenPerthWestern AustraliaActif, sans recrutement
Perth Children's HospitalPerthWestern AustraliaEn recrutement
Sydney Children's HospitalRandwickNew South WalesEn recrutement
Royal Hobart HospitalSaint HobartTasmaniaSuspendu
Queensland Children's HospitalSouth BrisbaneQueenslandEn recrutement
The Children's Hospital at WestmeadWestmeadNew South WalesEn recrutement

Canada

ÉtablissementVilleÉtat ou régionStatut
Alberta Children's HospitalCalgaryAlbertaEn recrutement
University of Alberta HospitalEdmontonAlbertaEn recrutement
IWK Health CentreHalifaxNova ScotiaEn recrutement
McMaster Children's Hospital at Hamilton Health SciencesHamiltonOntarioEn recrutement
Kingston Health Sciences CentreKingstonOntarioEn recrutement
Children's HospitalLondonOntarioEn recrutement
The Montreal Children's Hospital of the MUHCMontrealQuebecEn recrutement
Centre Hospitalier Universitaire Sainte-JustineMontrealQuebecEn recrutement
Children's Hospital of Eastern OntarioOttawaOntarioEn recrutement
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)QuébecEn recrutement
Saskatoon Cancer CentreSaskatoonSaskatchewanSuspendu
Jim Pattison Children's HospitalSaskatoonSaskatchewanEn recrutement
Centre Hospitalier Universitaire de Sherbrooke-FleurimontSherbrookeQuebecEn recrutement
Janeway Child Health CentreSt. John'sNewfoundland and LabradorEn recrutement
Hospital for Sick ChildrenTorontoOntarioSuspendu
British Columbia Children's HospitalVancouverBritish ColumbiaEn recrutement
CancerCare ManitobaWinnipegManitobaEn recrutement

New Zealand

ÉtablissementVilleÉtat ou régionStatut
Christchurch HospitalChristchurchEn recrutement
Starship Children's HospitalGraftonAucklandEn recrutement

Puerto Rico

ÉtablissementVilleÉtat ou régionStatut
HIMA San Pablo Oncologic HospitalCaguasActif, sans recrutement
University Pediatric HospitalSan JuanEn recrutement
San Jorge Children's HospitalSan JuanActif, sans recrutement

Saudi Arabia

ÉtablissementVilleÉtat ou régionStatut
King Faisal Specialist Hospital and Research CentreRiyadhSuspendu

United States

ÉtablissementVilleÉtat ou régionStatut
Children's Hospital Medical Center of AkronAkronOhioEn recrutement
Albany Medical CenterAlbanyNew YorkEn recrutement
Presbyterian HospitalAlbuquerqueNew MexicoEn recrutement
University of New Mexico Cancer CenterAlbuquerqueNew MexicoEn recrutement
Lehigh Valley Hospital-Cedar CrestAllentownPennsylvaniaEn recrutement
Texas Tech University Health Sciences Center-AmarilloAmarilloTexasSuspendu
Providence Alaska Medical CenterAnchorageAlaskaEn recrutement
C S Mott Children's HospitalAnn ArborMichiganEn recrutement
Mission HospitalAshevilleNorth CarolinaEn recrutement
Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlantaGeorgiaEn recrutement
Augusta University Medical CenterAugustaGeorgiaEn recrutement
Children's Hospital ColoradoAuroraColoradoEn recrutement
Rush-Copley Medical CenterAuroraIllinoisEn recrutement
Dell Children's Medical Center of Central TexasAustinTexasEn recrutement
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMarylandEn recrutement
University of Maryland/Greenebaum Cancer CenterBaltimoreMarylandEn recrutement
Sinai Hospital of BaltimoreBaltimoreMarylandEn recrutement

229 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 25 août 2026

    Site ajouté

    1 site added (279 total)

    278279

Registre: ClinicalTrials.gov · NCT########

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