Pilot Study to Assess the Feasibility of Centralizing Biological Samples at Onset and Relapse of Patients Referred to CROP Centers for Molecular Characterization of Oncohematologic Pathology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 340
- 试验地点
- 3
- 主要终点
- Average sample delivery time and % of accepted sample
研究概览
简要总结
Currently, the molecular characterization of onco-hematological, onco-immunological and hematological diseases, at onset or in relapse, of patients with suspected diagnosis afferent to the CROP centers, is done through centralization of biological samples at reference laboratories outside the Tuscany Region.
In order to preserve the wealth of clinical and biological data and use it for the benefit of present and future patients treated at the CROP centers, it is useful to evaluate the feasibility of centralization and molecular typing of mutations present in tumor tissue at the IRCCS AOU Meyer Oncohematology Laboratories and subsequently the analysis of clinical data from patients with diseases not under study to lay the foundations of a translational database that can then be associated with a biobank in the future.
This will enable a targeted contribution to pediatric oncohematology research, investing in possible targeted therapies with those patient subgroups that benefit from personalized disease assessment in mind. The goal of the project is to improve the regional infrastructure dedicated to organized data collection and management of biological samples in adequate time resulting in better and more comprehensive data collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 30 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic suspicion of oncologic, hematologic or onco-immunologic disease
- •Suspected recurrence of oncological, onco-hematological, hematological or onco -immunological disease
- •Availability of biological material
- •Signature of informed consent
- •Age between 0 and 30 years
排除标准
- •Failure to sign the consent
- •Insufficiency of biological material for analysis
- •Patients with HIV, HCV and HBV seropositivity (HBSAg) due to biohazard and bias related to patients' immunological status that could influence gene expression and tumor behavior.
结局指标
主要结局
Average sample delivery time and % of accepted sample
时间窗: After 5 year from the beginning of the study
average sample delivery time and % of samples accepted within 48 ±12 hours of collection out of total samples sent
Appropriateness sample labelling
时间窗: After 5 year from the beginning of the study
% samples correctly labelled according to IATA criteria out of total samples accepted within 48 hours
Percentage of sample suitable for RNA extraction
时间窗: After 5 year from the beginning of the study
% samples suitable for RNA extraction out of total samples intended for RNA analysis
Research report production time
时间窗: After 5 year from the beginning of the study
research report production time (from 2 weeks for known mutation analysis to 6 months for NGS).
Quantity and quality of extracted material.
时间窗: After 5 year from the beginning of the study
% of samples valid for analysis in terms of quantity of extracted material (25 ng/ul for cfDNA, 25 ng per amplicon for genomic DNA, 100 ng tot for NGS) and quality, assessed as A260/280 ratio analysis (1.8-2 per DNA).
次要结局
- Genetic variants(After 5 year from the beginning of the study)
- Completed patient cards(After 5 year from the beginning of the study)
研究者
Marinella Veltroni
Principal Investigator
Meyer Children's Hospital IRCCS
