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.
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Observational Project AYA Protocol | Other: Cytology Specimen Collection Procedure | 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 | Other: Cytology Specimen Collection Procedure; Other: Medical Chart Review | 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). |
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| Facility | City | Country | Status |
|---|---|---|---|
| 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 |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa, Florida | United States | Recruiting |
| Saint Mary's Medical Center | West Palm Beach, Florida | United States | Recruiting |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital | Atlanta, Georgia | United States | Recruiting |
| Augusta University Medical Center | Augusta, Georgia | United States | Recruiting |
| Atrium Health Navicent | Macon, Georgia | United States | Recruiting |
| Memorial Health University Medical Center | Savannah, Georgia | United States | Recruiting |
| Kapiolani Medical Center for Women and Children | Honolulu, Hawaii | United States | Recruiting |
| Tripler Army Medical Center | Honolulu, Hawaii | United States | Active not recruiting |
| Saint Luke's Cancer Institute - Boise | Boise, Idaho | United States | Recruiting |
| Rush-Copley Medical Center | Aurora, Illinois | United States | Recruiting |
| Lurie Children's Hospital-Chicago | Chicago, Illinois | United States | Recruiting |
| Northwestern University | Chicago, Illinois | United States | Recruiting |
| University of Illinois | Chicago, Illinois | United States | Recruiting |
| University of Chicago Comprehensive Cancer Center | Chicago, Illinois | United States | Recruiting |
| Carle at The Riverfront | Danville, Illinois | United States | Recruiting |
| Carle Physician Group-Effingham | Effingham, Illinois | United States | Recruiting |
| Carle Physician Group-Mattoon/Charleston | Mattoon, Illinois | United States | Recruiting |
| Loyola University Medical Center | Maywood, Illinois | United States | Recruiting |
| Carle BroMenn Medical Center | Normal, Illinois | United States | Recruiting |
| Carle Cancer Institute Normal | Normal, Illinois | United States | Recruiting |
| Advocate Children's Hospital-Oak Lawn | Oak Lawn, Illinois | United States | Recruiting |
| Advocate Children's Hospital-Park Ridge | Park Ridge, Illinois | United States | Recruiting |
| OSF Children's Hospital of Illinois | Peoria, Illinois | United States | Recruiting |
| Saint John's Hospital | Springfield, Illinois | United States | Recruiting |
| Southern Illinois University School of Medicine | Springfield, Illinois | United States | Recruiting |
| Carle Cancer Center | Urbana, Illinois | United States | Recruiting |
| Northwestern Medicine Central DuPage Hospital | Winfield, Illinois | United States | Recruiting |
| Rush-Copley Healthcare Center | Yorkville, Illinois | United States | Recruiting |
| Riley Hospital for Children | Indianapolis, Indiana | United States | Recruiting |
| Ascension Saint Vincent Indianapolis Hospital | Indianapolis, Indiana | United States | Recruiting |
| Blank Children's Hospital | Des Moines, Iowa | United States | Recruiting |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City, Iowa | United States | Recruiting |
| Wesley Medical Center | Wichita, Kansas | United States | Recruiting |
| University of Kentucky/Markey Cancer Center | Lexington, Kentucky | United States | Recruiting |
| Norton Children's Hospital | Louisville, Kentucky | United States | Recruiting |
| Children's Hospital New Orleans | New Orleans, Louisiana | United States | Recruiting |
| Ochsner Medical Center Jefferson | New Orleans, Louisiana | United States | Recruiting |
| Eastern Maine Medical Center | Bangor, Maine | United States | Recruiting |
| Maine Children's Cancer Program | Scarborough, Maine | United States | Recruiting |
| University of Maryland/Greenebaum Cancer Center | Baltimore, Maryland | United States | Recruiting |
| Sinai Hospital of Baltimore | Baltimore, Maryland | United States | Recruiting |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore, Maryland | United States | Recruiting |
| Walter Reed National Military Medical Center | Bethesda, Maryland | United States | Recruiting |
| Tufts Children's Hospital | Boston, Massachusetts | United States | Active not recruiting |
| Massachusetts General Hospital Cancer Center | Boston, Massachusetts | United States | Recruiting |
| Dana-Farber Cancer Institute | Boston, Massachusetts | United States | Recruiting |
| Baystate Medical Center | Springfield, Massachusetts | United States | Recruiting |
| UMass Memorial Medical Center - University Campus | Worcester, Massachusetts | United States | Recruiting |
| C S Mott Children's Hospital | Ann Arbor, Michigan | United States | Recruiting |
| Bronson Battle Creek | Battle Creek, Michigan | United States | Recruiting |
179 more sites not listed.
NIH grants: U10CA098543