跳至主要内容
临床试验/NCT06304194
NCT06304194招募中不适用

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

Meyer Children's Hospital IRCCS3 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2023年7月5日最近更新:
适应症

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

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

发起方
Meyer Children's Hospital IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marinella Veltroni

Principal Investigator

Meyer Children's Hospital IRCCS

研究点 (3)

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