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Project: Every Child for Younger Patients With Cancer

NCT02402244 — Recruiting, 75000 participants, Children's Oncology Group

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

RegistryNCT02402244
StatusRecruiting
Study typeObservational
Enrollment75000 (Estimated)
SponsorChildren's Oncology Group (Network); collaborators: National Cancer Institute (NCI)
ConditionsAdrenal 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
InterventionsCytology Specimen Collection Procedure, Medical Chart Review (Other)
Datesstart 2015-11-03, primary completion 2030-12-31 (estimated), completion 2030-12-31 (estimated), first posted 2015-03-30, last updated 2026-08-25
Locations279 sites in United States, Australia, Canada, New Zealand, Puerto Rico, Saudi Arabia

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-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.

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+Detailed description

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).

+Arms and interventions

ArmTypeInterventionsDescription
Observational Project AYA ProtocolOther: Cytology Specimen Collection ProcedurePatients undergo collection of biospecimen samples (e.g., tissue, blood, bone marrow, plasma, serum, buccal swab, saliva, cerebrospinal fluid, or urine).
Observational Project: Every Child ProtocolOther: Cytology Specimen Collection Procedure; Other: Medical Chart ReviewPatients 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).
  • Cytology Specimen Collection Procedure (Other), also known as Cytologic Sampling: Undergo cytology specimen collection
  • Medical Chart Review (Other), also known as Chart Review: Undergo medical data review

+Outcome measures

Primary outcomes

  • Number of patients who consented to biobanking [Baseline]: 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.

+Eligibility

Sex: All, ages: any to 25 Years

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

+Locations (279)

FacilityCityCountryStatus
Children's Hospital of AlabamaBirmingham, AlabamaUnited StatesRecruiting
USA Health Strada Patient Care CenterMobile, AlabamaUnited StatesRecruiting
Providence Alaska Medical CenterAnchorage, AlaskaUnited StatesRecruiting
Kingman Regional Medical CenterKingman, ArizonaUnited StatesRecruiting
Banner Children's at DesertMesa, ArizonaUnited StatesRecruiting
Phoenix Childrens HospitalPhoenix, ArizonaUnited StatesRecruiting
Banner University Medical Center - TucsonTucson, ArizonaUnited StatesRecruiting
Arkansas Children's HospitalLittle Rock, ArkansasUnited StatesRecruiting
Kaiser Permanente Downey Medical CenterDowney, CaliforniaUnited StatesRecruiting
City of Hope Comprehensive Cancer CenterDuarte, CaliforniaUnited StatesRecruiting
Loma Linda University Medical CenterLoma Linda, CaliforniaUnited StatesRecruiting
Miller Children's and Women's Hospital Long BeachLong Beach, CaliforniaUnited StatesRecruiting
Children's Hospital Los AngelesLos Angeles, CaliforniaUnited StatesRecruiting
Cedars-Sinai Medical CenterLos Angeles, CaliforniaUnited StatesRecruiting
Mattel Children's Hospital UCLALos Angeles, CaliforniaUnited StatesRecruiting
Valley Children's HospitalMadera, CaliforniaUnited StatesRecruiting
UCSF Benioff Children's Hospital OaklandOakland, CaliforniaUnited StatesRecruiting
Kaiser Permanente-OaklandOakland, CaliforniaUnited StatesRecruiting
Children's Hospital of Orange CountyOrange, CaliforniaUnited StatesRecruiting
Lucile Packard Children's Hospital Stanford UniversityPalo Alto, CaliforniaUnited StatesRecruiting
Sutter Medical Center SacramentoSacramento, CaliforniaUnited StatesRecruiting
University of California Davis Comprehensive Cancer CenterSacramento, CaliforniaUnited StatesRecruiting
Rady Children's Hospital - San DiegoSan Diego, CaliforniaUnited StatesRecruiting
Naval Medical Center -San DiegoSan Diego, CaliforniaUnited StatesRecruiting
UCSF Medical Center-Mission BaySan Francisco, CaliforniaUnited StatesRecruiting
Santa Barbara Cottage HospitalSanta Barbara, CaliforniaUnited StatesRecruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorrance, CaliforniaUnited StatesActive not recruiting
Children's Hospital ColoradoAurora, ColoradoUnited StatesRecruiting
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical CenterDenver, ColoradoUnited StatesRecruiting
Connecticut Children's Medical CenterHartford, ConnecticutUnited StatesRecruiting
Yale UniversityNew Haven, ConnecticutUnited StatesRecruiting
Alfred I duPont Hospital for ChildrenWilmington, DelawareUnited StatesRecruiting
MedStar Georgetown University HospitalWashington D.C., District of ColumbiaUnited StatesRecruiting
Children's National Medical CenterWashington D.C., District of ColumbiaUnited StatesRecruiting
Broward Health Medical CenterFort Lauderdale, FloridaUnited StatesRecruiting
Golisano Children's Hospital of Southwest FloridaFort Myers, FloridaUnited StatesRecruiting
UF Health Cancer Institute - GainesvilleGainesville, FloridaUnited StatesRecruiting
Memorial Regional Hospital/Joe DiMaggio Children's HospitalHollywood, FloridaUnited StatesRecruiting
Nemours Children's Clinic-JacksonvilleJacksonville, FloridaUnited StatesRecruiting
Palms West Radiation TherapyLoxahatchee Groves, FloridaUnited StatesActive not recruiting
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, FloridaUnited StatesRecruiting
Nicklaus Children's HospitalMiami, FloridaUnited StatesRecruiting
Miami Cancer InstituteMiami, FloridaUnited StatesRecruiting
AdventHealth OrlandoOrlando, FloridaUnited StatesRecruiting
Arnold Palmer Hospital for ChildrenOrlando, FloridaUnited StatesRecruiting
Nemours Children's HospitalOrlando, FloridaUnited StatesRecruiting
Nemours Children's Clinic - PensacolaPensacola, FloridaUnited StatesRecruiting
Sacred Heart HospitalPensacola, FloridaUnited StatesActive not recruiting
Johns Hopkins All Children's HospitalSt. Petersburg, FloridaUnited StatesRecruiting
Tampa General HospitalTampa, FloridaUnited StatesRecruiting
Saint Joseph's Hospital/Children's Hospital-TampaTampa, FloridaUnited StatesRecruiting
Saint Mary's Medical CenterWest Palm Beach, FloridaUnited StatesRecruiting
Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlanta, GeorgiaUnited StatesRecruiting
Augusta University Medical CenterAugusta, GeorgiaUnited StatesRecruiting
Atrium Health NavicentMacon, GeorgiaUnited StatesRecruiting
Memorial Health University Medical CenterSavannah, GeorgiaUnited StatesRecruiting
Kapiolani Medical Center for Women and ChildrenHonolulu, HawaiiUnited StatesRecruiting
Tripler Army Medical CenterHonolulu, HawaiiUnited StatesActive not recruiting
Saint Luke's Cancer Institute - BoiseBoise, IdahoUnited StatesRecruiting
Rush-Copley Medical CenterAurora, IllinoisUnited StatesRecruiting
Lurie Children's Hospital-ChicagoChicago, IllinoisUnited StatesRecruiting
Northwestern UniversityChicago, IllinoisUnited StatesRecruiting
University of IllinoisChicago, IllinoisUnited StatesRecruiting
University of Chicago Comprehensive Cancer CenterChicago, IllinoisUnited StatesRecruiting
Carle at The RiverfrontDanville, IllinoisUnited StatesRecruiting
Carle Physician Group-EffinghamEffingham, IllinoisUnited StatesRecruiting
Carle Physician Group-Mattoon/CharlestonMattoon, IllinoisUnited StatesRecruiting
Loyola University Medical CenterMaywood, IllinoisUnited StatesRecruiting
Carle BroMenn Medical CenterNormal, IllinoisUnited StatesRecruiting
Carle Cancer Institute NormalNormal, IllinoisUnited StatesRecruiting
Advocate Children's Hospital-Oak LawnOak Lawn, IllinoisUnited StatesRecruiting
Advocate Children's Hospital-Park RidgePark Ridge, IllinoisUnited StatesRecruiting
OSF Children's Hospital of IllinoisPeoria, IllinoisUnited StatesRecruiting
Saint John's HospitalSpringfield, IllinoisUnited StatesRecruiting
Southern Illinois University School of MedicineSpringfield, IllinoisUnited StatesRecruiting
Carle Cancer CenterUrbana, IllinoisUnited StatesRecruiting
Northwestern Medicine Central DuPage HospitalWinfield, IllinoisUnited StatesRecruiting
Rush-Copley Healthcare CenterYorkville, IllinoisUnited StatesRecruiting
Riley Hospital for ChildrenIndianapolis, IndianaUnited StatesRecruiting
Ascension Saint Vincent Indianapolis HospitalIndianapolis, IndianaUnited StatesRecruiting
Blank Children's HospitalDes Moines, IowaUnited StatesRecruiting
University of Iowa/Holden Comprehensive Cancer CenterIowa City, IowaUnited StatesRecruiting
Wesley Medical CenterWichita, KansasUnited StatesRecruiting
University of Kentucky/Markey Cancer CenterLexington, KentuckyUnited StatesRecruiting
Norton Children's HospitalLouisville, KentuckyUnited StatesRecruiting
Children's Hospital New OrleansNew Orleans, LouisianaUnited StatesRecruiting
Ochsner Medical Center JeffersonNew Orleans, LouisianaUnited StatesRecruiting
Eastern Maine Medical CenterBangor, MaineUnited StatesRecruiting
Maine Children's Cancer ProgramScarborough, MaineUnited StatesRecruiting
University of Maryland/Greenebaum Cancer CenterBaltimore, MarylandUnited StatesRecruiting
Sinai Hospital of BaltimoreBaltimore, MarylandUnited StatesRecruiting
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimore, MarylandUnited StatesRecruiting
Walter Reed National Military Medical CenterBethesda, MarylandUnited StatesRecruiting
Tufts Children's HospitalBoston, MassachusettsUnited StatesActive not recruiting
Massachusetts General Hospital Cancer CenterBoston, MassachusettsUnited StatesRecruiting
Dana-Farber Cancer InstituteBoston, MassachusettsUnited StatesRecruiting
Baystate Medical CenterSpringfield, MassachusettsUnited StatesRecruiting
UMass Memorial Medical Center - University CampusWorcester, MassachusettsUnited StatesRecruiting
C S Mott Children's HospitalAnn Arbor, MichiganUnited StatesRecruiting
Bronson Battle CreekBattle Creek, MichiganUnited StatesRecruiting

179 more sites not listed.

+Investigators

+Funding

NIH grants: U10CA098543

My Notes