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

NCT03115138 | Terminated

• 1 other identifier: PI2015_843_0029
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma; Molecular Disease

Keywords

Biopsy

Outcome Measures

Primary Outcomes (1)

• Presence of a correlation between the molecular abnormalities of the primary tumor and the circulating tumor DNA

  1 year

Study Arms (1)

Patients with glial tumor

OTHER

Other: Correlation between molecular anomalies of the primary tumor and circulating tumor DNA

Interventions

Correlation between molecular anomalies of the primary tumor and circulating tumor DNA OTHER

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.

Patients with glial tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Glioblastoma; Genetic Diseases, Inborn

Interventions

Circulating Tumor DNA

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cell-Free Nucleic Acids; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; DNA, Neoplasm; DNA

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 14, 2017
• Study Start: March 9, 2016
• Primary Completion: November 6, 2017
• Study Completion: November 6, 2017
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

FR (1)