Evaluation of Circulating Tumor DNA as a Theranostic Marker in the Management of Glioblastomas.

Not Applicable

Terminated

• Conditions: Molecular Disease; Glioblastoma
• Interventions: Other: Correlation between molecular anomalies of the primary tumor and circulating tumor DNA

• Registration Number: NCT03115138
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

Glioblastomas (GBM) are rare tumors of poor prognosis and their treatment is based on surgery followed by radiochemotherapy. Clinical and imaging evaluation is not always straightforward: the more or less complete surgery, the pseudo-progression after radiochemotherapy, the radionecrosis, the diagnosis of the relapse and the follow-up under anti-angiogenic can pose problems Clinicians and radiologists. Accessibility to a plasma tumor molecular marker would greatly facilitate the follow-up of these patients.

It is now established for many cancers that circulating tumor DNA (cTNA) has the same molecular abnormalities as those identified in the primary tumor cells. Numerous studies have shown the prognostic value and diagnosis of the exploration of cDNA.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-09
• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Primary Completion: 2017-11-06
• Study Completion: 2017-11-06
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Patients with grade IV glial tumor (glioblastoma according to WHO criteria) for which an indication of surgical excision with radiochemotherapy was chosen at a specialized multidisciplinary meeting of neuro-oncology at the CHU Amiens-Picardy.

• Patients should:

  • be able to be followed at the CHU of Amiens throughout their treatment,
  • be at least 18 years of age,
  • be informed (or trusted) of the conditions and objectives of the study,
  • having given their free and informed consent in writing,
  • have a life expectancy of more than 6 months,
  • be affiliated to a social security scheme.

Exclusion Criteria

• Patients with recurrent tumors.
• Patients supported for another histology.
• Medical, psychological or social conditions that do not allow for proper understanding of the procedures inherent in the study.
• Patients under tutelage, curatorship.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with glial tumor	Correlation between molecular anomalies of the primary tumor and circulating tumor DNA	-

Primary Outcome Measures

Name	Time	Method
Presence of a correlation between the molecular abnormalities of the primary tumor and the circulating tumor DNA	1 year

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, Picardie, France