Gathering health information for younger cancer patients
The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study
Children's Oncology Group · NCT02402244
This study is gathering health information from younger cancer patients to help improve treatments and support future research.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75000 (estimated) |
| Ages | N/A to 25 Years |
| Sex | All |
| Sponsor | Children's Oncology Group (network) |
| Locations | 278 sites (Birmingham, Alabama and 277 other locations) |
| Trial ID | NCT02402244 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a comprehensive Childhood Cancer Registry for infants, children, adolescents, and young adults diagnosed with cancer. It involves collecting clinical and biological data to determine eligibility for future therapeutic clinical trials and developing a biorepository for ongoing research. Patients will undergo medical data reviews and biospecimen collection, including various biological samples, to support better treatment methods and care strategies. The registry will also facilitate future contact for non-therapeutic and prevention research studies.
Who should consider this trial
Good fit: Ideal candidates include infants, children, adolescents, and young adults diagnosed with various types of cancer within six months of their initial diagnosis or disease progression.
Not a fit: Patients with cancers that do not meet the specified eligibility criteria or those who are not diagnosed within the required time frame may not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could lead to improved treatment methods and ongoing care for younger patients with cancer.
How similar studies have performed: Other studies have successfully utilized similar registry and biospecimen collection approaches to enhance cancer research and treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama and 277 other locations
- Children's Hospital of Alabama — Birmingham, Alabama, United States (RECRUITING)
- USA Health Strada Patient Care Center — Mobile, Alabama, United States (RECRUITING)
- Providence Alaska Medical Center — Anchorage, Alaska, United States (RECRUITING)
- Kingman Regional Medical Center — Kingman, Arizona, United States (RECRUITING)
- Banner Children's at Desert — Mesa, Arizona, United States (RECRUITING)
- Phoenix Childrens Hospital — Phoenix, Arizona, United States (RECRUITING)
- Banner University Medical Center - Tucson — Tucson, Arizona, United States (RECRUITING)
- Arkansas Children's Hospital — Little Rock, Arkansas, United States (RECRUITING)
- Kaiser Permanente Downey Medical Center — Downey, California, United States (RECRUITING)
- City of Hope Comprehensive Cancer Center — Duarte, California, United States (RECRUITING)
- Loma Linda University Medical Center — Loma Linda, California, United States (RECRUITING)
- Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States (RECRUITING)
- Children's Hospital Los Angeles — Los Angeles, California, United States (RECRUITING)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (RECRUITING)
- Mattel Children's Hospital UCLA — Los Angeles, California, United States (RECRUITING)
- Valley Children's Hospital — Madera, California, United States (RECRUITING)
- UCSF Benioff Children's Hospital Oakland — Oakland, California, United States (RECRUITING)
- Kaiser Permanente-Oakland — Oakland, California, United States (RECRUITING)
- Children's Hospital of Orange County — Orange, California, United States (RECRUITING)
- Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States (RECRUITING)
- Sutter Medical Center Sacramento — Sacramento, California, United States (RECRUITING)
- University of California Davis Comprehensive Cancer Center — Sacramento, California, United States (RECRUITING)
- Rady Children's Hospital - San Diego — San Diego, California, United States (RECRUITING)
- Naval Medical Center -San Diego — San Diego, California, United States (RECRUITING)
- UCSF Medical Center-Mission Bay — San Francisco, California, United States (RECRUITING)
- Santa Barbara Cottage Hospital — Santa Barbara, California, United States (RECRUITING)
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States (ACTIVE_NOT_RECRUITING)
- Children's Hospital Colorado — Aurora, Colorado, United States (RECRUITING)
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States (RECRUITING)
- Connecticut Children's Medical Center — Hartford, Connecticut, United States (RECRUITING)
- Yale University — New Haven, Connecticut, United States (RECRUITING)
- Alfred I duPont Hospital for Children — Wilmington, Delaware, United States (RECRUITING)
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States (RECRUITING)
- Children's National Medical Center — Washington D.C., District of Columbia, United States (RECRUITING)
- Broward Health Medical Center — Fort Lauderdale, Florida, United States (RECRUITING)
- Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States (RECRUITING)
- UF Health Cancer Institute - Gainesville — Gainesville, Florida, United States (RECRUITING)
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida, United States (RECRUITING)
- Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States (RECRUITING)
- Palms West Radiation Therapy — Loxahatchee Groves, Florida, United States (ACTIVE_NOT_RECRUITING)
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States (RECRUITING)
- Nicklaus Children's Hospital — Miami, Florida, United States (RECRUITING)
- Miami Cancer Institute — Miami, Florida, United States (RECRUITING)
- AdventHealth Orlando — Orlando, Florida, United States (RECRUITING)
- Arnold Palmer Hospital for Children — Orlando, Florida, United States (RECRUITING)
- Nemours Children's Hospital — Orlando, Florida, United States (RECRUITING)
- Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States (RECRUITING)
- Sacred Heart Hospital — Pensacola, Florida, United States (ACTIVE_NOT_RECRUITING)
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States (RECRUITING)
- Tampa General Hospital — Tampa, Florida, United States (RECRUITING)
+228 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Douglas S Hawkins — Children's Oncology Group
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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