The circTeloDIAG: Liquid Biopsy for Glioma Tumor

NCT04931732 | Recruiting

• 1 other identifier: 69HCL20_0461
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioma

Keywords

liquid biopsy; glioma; pseudoprogression; relapse

Outcome Measures

Primary Outcomes (1)

• ctDNA analysis

  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

  At inclusion

Study Arms (2)

Diagnosis

Biological: ctDNA analysis

Relapse

Biological: ctDNA analysis

Interventions

ctDNA analysis BIOLOGICAL

ctDNA analysis of patients with suspected primary glioma tumors and in patients with suspected recurrence.

Diagnosis; Relapse

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected glioma and patients with suspected recurrent glioma

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

East Group Hospital, Hospices Civils de Lyon

Bron, 69677, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

ctDNA of blood's patient with glioma tumour

MeSH Terms

Conditions

Glioma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

GARNIER Louis, Dr

CONTACT

+33 (0)4 72 68 13 59; louis.garnier@chu-lyon.fr

Delphine PONCET, Dr

CONTACT

+33 (0)4 27 85 57 34; delphine.poncet@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 18, 2021
• Study Start: November 4, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)