跳至主要内容
临床试验/NCT06826066
NCT06826066招募中不适用

Involvement of the Immune System in Intrinsic Radiosensitivity

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月12日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Identify immunological markers predictive of intrinsic radiosensitivity.

研究概览

简要总结

Radiotherapy is one of the major treatments for cancer. It may be indicated in more than two-thirds of patients, regardless of cancer location or disease stage. The mechanisms of radiotherapy action are numerous: halting tumor proliferation, inducing tumor cell death, triggering anti-tumor immune responses, and ensuring both local and systemic tumor control. As a result, current treatments are highly effective, providing, for instance, a 5-year overall survival rate of about 90%-95% for localized breast and prostate cancers.

详细描述

In everyday clinical practice, the indications for radiotherapy are based on the benefit-to-risk ratio concerning toxicity. In most cases, radiotherapy causes mild to moderate acute or late side effects, depending on the patient and the volumes irradiated. However, in 1% to 5% of treated patients, these side effects can be severe, unexpected, and often unexplained. The cause of this toxicity remains poorly understood and largely unexplored, especially concerning the intrinsic radiosensitivity of patients.

The PROUST study (French Registry for Review of Morbidity and Mortality; RMM) was initiated in France to prospectively collect clinical, dosimetric, and biological data on individual radiosensitivity in patients who experience severe radiation-induced toxicity. The goal of this study is to better characterize patients with severe radiation-induced toxicities and identify the cellular factors involved in this toxicity.

Although the aim is to identify the cellular and molecular immune factors involved in severe radiation-induced toxicity, we currently cannot determine whether the immune monitoring observed in radiosensitive patients is a consequence of the toxicity itself or of radiotherapy. To answer this question, we have decided to create a control cohort, called TRANSPROUST, which includes patients treated with radiotherapy but who did not experience severe radiation-induced toxicity. After obtaining consent from patients who were treated with radiotherapy but did not develop severe toxicity, we will collect blood samples similar to those taken from the severe toxicity cohort.

These samples will undergo flow cytometry analysis, and the results will be compared with those of patients included in the PROUST cohort.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Age ≥ 18 years
  • Patients who have been treated with radiotherapy
  • Absence of toxicity grade 2 or higher
  • Patients without psychiatric, sociological, family, or geographical difficulties that could interfere with patient compliance to the protocol or follow-up
  • Information and signed informed consent
  • Affiliated with social security

排除标准

  • Inability to obtain patient consent
  • Patient refusing blood sample collection
  • Patient deprived of liberty or under legal protection (under guardianship, under curatorship)
  • Patients who have experienced radiation-induced toxicity of grade 2 or higher
  • Disease progression, relapse
  • Patient under State Medical Aid

研究组 & 干预措施

TRANSPROUST is a prospective, single-center cohort.

Experimental

干预措施: Blood samples (Other)

结局指标

主要结局

Identify immunological markers predictive of intrinsic radiosensitivity.

时间窗: 48 hours

Identification of immunological markers predictive of intrinsic radiosensitivity using flow cytometry analysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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