The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75,000
- 试验地点
- 561
- 主要终点
- Number of patients who consented to biobanking
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Observational Project AYA Protocol
Patients undergo collection of biospecimen samples (e.g., tissue, blood, bone marrow, plasma, serum, buccal swab, saliva, cerebrospinal fluid, or urine).
干预措施: Cytology Specimen Collection Procedure (Other)
Observational 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).
干预措施: Cytology Specimen Collection Procedure (Other)
Observational 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).
干预措施: Medical Chart Review (Other)
结局指标
主要结局
Number of patients who consented to biobanking
时间窗: 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.
次要结局
未报告次要终点