Relapsed and Refractory Hepatoblastoma: A Prospective Registry and Hepatic Tumors Research Consortium Initiative
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Clinical data and biological data correlation
研究概览
简要总结
There are limited data regarding the biology and treatment of relapsed/refractory hepatoblastoma (rrHBL). This project provides the infrastructure for acquisition of biological specimens, imaging, and correlative clinical data to facilitate biology studies and characterization of rrHBL. This registry will collect clinical, demographic, and pathological data, specimens (as available) and imaging from patients with rrHBL, prospectively. Cases are identified through:
- Existing clinical and/or cancer registry databases
- Referrals from clinicians, surgeons, or pathologists
- Families initiating contact with Registry staff directly
详细描述
The following data/materials will be collected:
Clinical Data: Demographic data, date of diagnosis, pathology, radiological imaging data, signs and symptoms at diagnosis, molecular and biological data, staging details including sites of disease, detailed treatment data (e.g. types and dates of surgeries/interventional therapy (if any), medical/systemic therapy, radiotherapy), response to treatment (imaging and tumor markers), dates of progression, types of progression (local or metastatic), and follow-up data. The demographic and clinical data collected are abstracted and entered into an electronic data system secured by password protection. Collection of existing molecular and/or genomic data or analysis that has been performed will also be included.
Research Specimens:
Tissue (fresh/frozen/FFPE) from diagnosis and all subsequent timepoints where tissue was acquired (for example at each relapse and/or progression) will be requested for all enrolled patients and sent for central review to the study pathologist and stored in the rrHBL biorepository within the Cancer and Blood Disease Institute at Cincinnati Children's Hospital Medical Center. Future research testing may be conducted on this tissue.
Optional research specimens:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients of any age with a suspected diagnosis (per treating oncologist/surgeon) or confirmed diagnosis of a rrHBL and all patients with Hepatocellular Malignant Neoplasm- Not Otherwise Specified (HCN-NOS) who are <6 years of age at the time of initial diagnosis
- •To allow for tumor modelling to be performed with fresh tissue from these cases, patients with suspected rrHBL are eligible to enroll on study
- •Unless the patient is deceased, all patients and/or one parent or legal guardian must provide written informed consent as well as HIPAA/release of information consent
排除标准
- 未提供
研究组 & 干预措施
Group 1
Patients with relapsed/ refractory Hepatoblastoma
干预措施: Biospecimen collection (Other)
结局指标
主要结局
Clinical data and biological data correlation
时间窗: From enrollment until data analysis is complete - assessed up to 40 years
To correlate registry clinical data with biological/bioinformatic data
Characterization of relapsed or refractory Hepatoblastoma
时间窗: From enrollment until data analysis is complete - assessed up to 40 years
To characterize rrHBL across all age groups with regards to demographics, presenting features, pathology, radiology, clinical course, treatments and response
Create biorepository of specimens
时间窗: From enrollment until data analysis is complete - retained up to 40 years
To create a biorepository of specimens from patients with rrHBL or suspected to have rrHBL to enhance molecular/biological investigations
次要结局
未报告次要终点