Back to resultsEvaluation of Circulating Tumor DNA as a Theranostic Marker in the Management of Glioblastomas. (Bi-GLAM)
Primary Purpose
Glioblastoma, Molecular Disease
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Correlation between molecular anomalies of the primary tumor and circulating tumor DNA
Sponsored by
About this trial
This is an interventional other trial for Glioblastoma focused on measuring Biopsy
Eligibility Criteria
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.
Sites / Locations
- CHU Amiens Picardie
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with glial tumor
Arm Description
Outcomes
Primary Outcome Measures
Presence of a correlation between the molecular abnormalities of the primary tumor and the circulating tumor DNA
Secondary Outcome Measures
Full Information
NCT ID
NCT03115138
First Posted
April 4, 2017
Last Updated
July 13, 2020
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03115138
Brief Title
Evaluation of Circulating Tumor DNA as a Theranostic Marker in the Management of Glioblastomas.
Acronym
Bi-GLAM
Official Title
Evaluation of Circulating Tumor DNA as a Theranostic Marker in the Management of Glioblastomas.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
investigator choice
Study Start Date
March 9, 2016 (Actual)
Primary Completion Date
November 6, 2017 (Actual)
Study Completion Date
November 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Molecular Disease
Keywords
Biopsy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with glial tumor
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Correlation between molecular anomalies of the primary tumor and circulating tumor DNA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence of a correlation between the molecular abnormalities of the primary tumor and the circulating tumor DNA
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Circulating Tumor DNA as a Theranostic Marker in the Management of Glioblastomas.
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