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

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Disease Information

Descriptive Information
Brief Title † Evaluation of Circulating Tumor DNA as a Theranostic Marker in the Management of Glioblastomas.
Official Title † Evaluation of Circulating Tumor DNA as a Theranostic Marker in the Management of Glioblastomas.
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
Study Phase N/A
Study Type † Interventional
Study Design †
Primary Outcome Measure † Presence of a correlation between the molecular abnormalities of the primary tumor and the circulating tumor DNA
Secondary Outcome Measure †
Condition † Glioblastoma Molecular Disease
Intervention † OtherCorrelation between molecular anomalies of the primary tumor and circulating tumor DNA
Study Arms / Comparison Groups Patients with glial tumor
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Other
Estimated Enrollment † 100
Start Date † March 9, 2016
Completion Date March 8, 2020
Primary Completion Date March 8, 2020
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.
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Brigitte GUBLER, Dr, +33322087070, gubler.brigitte@chu-amiens.fr
Location Countries † France
Administrative Information
NCT ID † NCT03115138
Organization ID PI2015_843_0029
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Centre Hospitalier Universitaire, Amiens
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date April 2017
First Received Date † April 4, 2017
Last Updated Date April 10, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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