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

Glioblastoma Clinical Trial

— Bi-GLAM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03115138
• Other study ID #: PI2015_843_0029
• Status: Terminated
• Phase: N/A
• Start date: March 9, 2016
• Est. completion date: November 6, 2017

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: November 6, 2017
• Est. primary completion date: November 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Molecular Disease

Intervention

Other:
• Correlation between molecular anomalies of the primary tumor and circulating tumor DNA
The presence of a specific abnormality initially identified on the primary tumor and which can be quantified in the cDNA during the management will allow a better follow-up of the patient.

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of a correlation between the molecular abnormalities of the primary tumor and the circulating tumor DNA		1 year