NCT04931732 The circTeloDIAG: Liquid Biopsy for Glioma Tumor
| NCT ID | NCT04931732 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Glioma |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-11-04 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2021-11-04 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Rejection of consent by patient * Hemoglobin \< 7g/dl * Rejection of surgery by patient * Suspected grade I tumor on MRI
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04931732 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04931732 currently recruiting?
Yes, NCT04931732 is actively recruiting participants. Contact the research team at louis.garnier@chu-lyon.fr for enrollment information.
Where is the NCT04931732 trial being conducted?
This trial is being conducted at Bron, France.
Who is sponsoring the NCT04931732 clinical trial?
NCT04931732 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 150 participants.