跳至主要内容
临床试验/NCT04931732
NCT04931732招募中不适用

The circTeloDIAG: a New Approach of Liquid Biopsy for the Diagnosis and Follow-up of Patients With Glioma Tumor

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
ctDNA analysis

研究概览

简要总结

Gliomas represent the most frequent primary brain tumor, with 2,500 to 3,000 new cases per year in France. Their diagnosis, although highly complex, is essential for determining patient management. While grade I gliomas (infrequent) are curable by surgery or present a slow progression, grades II to IV require heavy treatment (surgery and radio-chemotherapy), and are associated with a prognosis ranging from 10-15 years for grade II to only 15 months for glioblastoma.

One of the key processes in glioma oncogenesis is the activation of a telomeric maintenance mechanism (TMM). Two TMMs ensure the maintenance of a telomere size compatible with intense cell proliferation (TERT mutation and ATRX loss).

Liquid biopsy is used for the routine diagnosis and monitoring of treatment efficacy of different cancers. To date, no routine clinical testing of liquid biopsies is available for gliomas.

The detection of glioma-specific oncogenic processes, by liquid biopsy, in peripheral blood (ctDNA) could improve diagnosis and follow-up and then avoid surgery for patients with suspected lesions.

Three oncogenic markers can be used to detect gliomas: IDH mutation, TERT mutation, and a marker correlated with ATRX loss on total blood cells.

We hypothesized that the circTeloDIAG will improve and accelerate the diagnostic/prognostic value of the actual classification and provide a new tool to manage patient response to treatment via liquid biopsy. It will combine detection of three markers in liquid biopsy, to produce a versatile tool for all types of gliomas.

Patients with suspected newly diagnosed or recurrent glioma will be included.

详细描述

Gliomas, heterogeneous and aggressive tumors awaiting new therapeutic approaches.

Gliomas are the most frequent primary brain tumors, with 2,500 to 3,000 new cases per year in France. They concern the elderly but can also affect children and young adults. Their diagnosis is often complex (differential diagnoses, delicate classification). However, this diagnosis is essential to determine the therapeutic management. Thus, while grade I gliomas (infrequent) are curable by surgery or have a slow progression, grades II to IV have a cost in terms of therapeutic costs (surgery and radio-chemotherapy), in connection with a prognosis ranging from heavy 10-15 years for grades II to only 15 months for glioblastoma (grade IV). New biotherapies (such as anti-VEGF) have not improved the prognosis and to date there are no targeted therapies or immune systems that have shown a benefit.

It is more than ever necessary to propose targeted treatments against alterations of each type of glioma and to develop in parallel the therapeutic tests allowing their prescription.

DIAGNOSIS OF GLIOMAS: IMPORTANCE OF BIOMARKERS

The diagnosis of gliomas was subject to a high rate of inter-observer discrepancies. Molecular criteria have recently made it possible to refine and secure the diagnosis1. Thus, in hospital routine, mutations in Isocitrate Dehydrogenases (IDH1 and 2), 1p19q deletion, EGFR amplification, loss of CDKN2A, mutations in histones H3.3 and H3.1 (G35R / V, K28M), methylation of MGMT, as well as two telomeric markers: mutations of the TERT promoter (TERTmt) and the deletion of ATRX (lost ATRX) (see below). Thus, the new "histo-molecular" classification of WHO1 (2016) and its following updates define different classes of gliomas:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient
  • Obtainment of written informed consent
  • Suspected newly or recurrent glioma (grade ≥ II) on MRI
  • Patient eligible for surgery (biopsy or resection)
  • Decision of surgery (biopsy or resection) at neuro-oncology interdisciplinary tumor board

排除标准

  • Rejection of consent by patient
  • Hemoglobin < 7g/dl
  • Rejection of surgery by patient
  • Suspected grade I tumor on MRI

结局指标

主要结局

ctDNA analysis

时间窗: At inclusion

The main objective is to evaluate the performances of the diagnostic test "circTeloDIAG" dedicated to liquid biopsy. Primary endpoint is the sensitivity and specificity of the circTeloDIAG assay, at time of initial surgery. It will be established in CTCs in comparison with tumoral with positivity of one of the three markers tested

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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