EVERYCHILD PROTOCOL
A REGISTRY, ELIGIBILITY SCREENING, BIOLOGY AND OUTCOME STUDY
a study on Pheochromocytoma Carcinoma In Situ Central Nervous System Neoplasms Teratoma Langerhans Cell Histiocytosis Mesoblastic Nephroma Desmoid Tumor Ganglioneuroma Lymphoproliferative Disorders Malignant Neoplasm Neoplasms Solid Neoplasm Melanocytic Neoplasm Myeloproliferative Neoplasms Neoplasm of Uncertain Malignant Potential Neuroendocrine Neoplasm Stromal Neoplasm Neuroendocrine Tumor Skin Cancer/Melanoma
Summary
- Eligibility
- for people ages up to 25 years (full criteria)
- Location
- at Sacramento, California and other locations
- Dates
- study startedcompletion around
- Principal Investigator
- by Marcio H. Malogolowkin
Description
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.
Official Title
The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study
Details
PRIMARY OBJECTIVES:
- 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 biorespository 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 use of registry data for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the child or their parents.
OUTLINE:
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).
Keywords
Adrenal Gland Pheochromocytoma, Carcinoma In Situ, Central Nervous System Neoplasm, Childhood Immature Teratoma, 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, Neoplasms, Pheochromocytoma, Teratoma, Neuroendocrine Tumors, Aggressive Fibromatosis, Nervous System Neoplasms, Central Nervous System Neoplasms, Fibroma, Mesoblastic Nephroma, Melanoma, Langerhans-Cell Histiocytosis, Myeloproliferative Disorders, Lymphoproliferative Disorders, Histiocytosis, Cytology Specimen Collection Procedure, Medical Chart Review
Eligibility
For people ages up 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
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
- University of California Davis Comprehensive Cancer Center
accepting new patients
Sacramento California 95817 United States - Sutter Medical Center Sacramento
accepting new patients
Sacramento California 95816 United States
Lead Scientist at UC Davis
- Marcio H. Malogolowkin
Professor, MED: Pediatrics, School of Medicine. Authored (or co-authored) 123 research publications
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Children's Oncology Group
- Links
- Sign up for this study
- ID
- NCT02402244
- Study Type
- Observational
- Participants
- Expecting 33000 study participants
- Last Updated
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