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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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.

Beobachtend75.000 Teilnehmende gesucht279 Studienzentren6 Länder

Kategorien

Onkologie67%Nephrologie und Urologie12%Seltene und genetische Erkrankungen5%Hämatologie4%Endokrin und metabolisch4%Neurologie2%Immunologie und Rheumatologie2%Dermatologie2%Geburtshilfe und Gynäkologie2%

In 1 Register registriert

ClinicalTrials.govNCT02402244Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 4 Wochen

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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.

Zusammenfassung

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).

Erkrankungen

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

Eignung

Eignung
Geschlecht	Alle
Alter	Kein Mindestalter – 25 Years
Gesunde Freiwillige	Nein
Stichprobenverfahren	NON_PROBABILITY_SAMPLE

Studienpopulation

Patients with cancer enrolled on COG therapeutic study

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Beobachtend
Phase	Im Registereintrag nicht angegeben
Zuteilung	Im Registereintrag nicht angegeben
Interventionsmodell	Im Registereintrag nicht angegeben
Primäres Ziel	Im Registereintrag nicht angegeben
Verblindung	Im Registereintrag nicht angegeben
Teilnahme	75.000 Teilnehmende gesucht

Sponsor und Mitwirkende

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

Studienarme und Interventionen

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).

Interventionen

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

Endpunkte

Primärer Endpunkt
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.
Zeitrahmen Baseline

Daten

Daten
Startdatum	3. November 2015 (tatsächlich)
Primärer Abschluss	31. Dezember 2030 (geschätzt)
Abschluss	31. Dezember 2030 (geschätzt)
Erstveröffentlichung	30. März 2015 (geschätzt)
Zuletzt aktualisiert	25. August 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Februar 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

253 Studienzentren rekrutieren

Australia

Australia
Einrichtung	Stadt	Bundesland oder Region	Status
Monash Medical Center-Clayton Campus	Clayton	Victoria	Rekrutiert
John Hunter Children's Hospital	Hunter Regional Mail Centre	New South Wales	Rekrutiert
Women's and Children's Hospital-Adelaide	North Adelaide	South Australia	Rekrutiert
Royal Children's Hospital	Parkville	Victoria	Rekrutiert
Princess Margaret Hospital for Children	Perth	Western Australia	Aktiv, rekrutiert nicht
Perth Children's Hospital	Perth	Western Australia	Rekrutiert
Sydney Children's Hospital	Randwick	New South Wales	Rekrutiert
Royal Hobart Hospital	Saint Hobart	Tasmania	Ausgesetzt
Queensland Children's Hospital	South Brisbane	Queensland	Rekrutiert
The Children's Hospital at Westmead	Westmead	New South Wales	Rekrutiert

Canada

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

New Zealand

New Zealand
Einrichtung	Stadt	Bundesland oder Region	Status
Christchurch Hospital	Christchurch		Rekrutiert
Starship Children's Hospital	Grafton	Auckland	Rekrutiert

Puerto Rico

Puerto Rico
Einrichtung	Stadt	Status
HIMA San Pablo Oncologic Hospital	Caguas	Aktiv, rekrutiert nicht
University Pediatric Hospital	San Juan	Rekrutiert
San Jorge Children's Hospital	San Juan	Aktiv, rekrutiert nicht

Saudi Arabia

Saudi Arabia
Einrichtung	Stadt	Bundesland oder Region	Status
King Faisal Specialist Hospital and Research Centre	Riyadh		Ausgesetzt

United States

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

229 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

25. August 2026
Studienzentrum hinzugefügt
1 site added (279 total)
278279

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