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 started
completion 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:

  1. 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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