跳至主要内容
临床试验/NCT07112989
NCT07112989招募中不适用

Development of Innovative Preclinical Ex Vivo Models for the Study of Sarcomas and Metastases From Solid Tumors

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2024年9月23日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
125
试验地点
1
主要终点
Number of tumor samples enabling the development of at least three preclinical models

研究概览

简要总结

The goal of this observational study is to learn how tumor tissue and blood samples from patients with sarcomas or metastases can be used to create laboratory models that help researchers study cancer behavior and test new treatments. Participants diagnosed with sarcoma or with bone or lung metastases from solid tumors will donate leftover tumor tissue and blood collected during their regular medical care. These samples will be used in the lab to build 3D models of the tumor, test drugs, and identify genetic and molecular markers. No treatments or procedures will be given as part of the study.

详细描述

PREMOD is a prospective, observational, preclinical study designed to develop and optimize innovative tumor models derived from patients diagnosed with sarcomas or with bone/lung metastases from solid tumors. These models include tumor explants, primary cultures, spheroids, scaffold-based 3D cultures, 3D bioprinted models, alginate capsules, and the chorioallantoic membrane (CAM) model.

Study Objectives

Primary Objective:

  • To develop and optimize innovative preclinical models for study sarcomas and metastases.

Secondary Objectives:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients (male or female) diagnosed with sarcoma or with bone or lung metastases from solid tumors
  • Age between 0 and 85 years
  • Availability of sufficient and adequate biological material (tumor tissue and/or blood)
  • Signed informed consent for biobanking (BIOTUM)
  • Signed informed consent for use of tissue and blood samples in this study

排除标准

  • Diagnosis other than sarcoma or metastases from solid tumors
  • Missing signed informed consent(s)

结局指标

主要结局

Number of tumor samples enabling the development of at least three preclinical models

时间窗: 7 years

Number of patient-derived tumor samples that allow the successful development of at least three distinct preclinical models (e.g., spheroids, explants, scaffold-based cultures, or bioprinted constructs). This outcome assesses the feasibility and robustness of the tissue-based modeling approach.

次要结局

  • Evaluation of the quality of the models(7 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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