Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The circTeloDIAG: Liquid Biopsy for Glioma Tumor (circTeloDIAG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04931732
Recruitment Status : Recruiting
First Posted : June 18, 2021
Last Update Posted : August 9, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Gliomas represent the most frequent primary brain tumor, with 2,500 to 3,000 new cases per year in France. Their diagnosis, although highly complex, is essential for determining patient management. While grade I gliomas (infrequent) are curable by surgery or present a slow progression, grades II to IV require heavy treatment (surgery and radio-chemotherapy), and are associated with a prognosis ranging from 10-15 years for grade II to only 15 months for glioblastoma.

One of the key processes in glioma oncogenesis is the activation of a telomeric maintenance mechanism (TMM). Two TMMs ensure the maintenance of a telomere size compatible with intense cell proliferation (TERT mutation and ATRX loss).

Liquid biopsy is used for the routine diagnosis and monitoring of treatment efficacy of different cancers. To date, no routine clinical testing of liquid biopsies is available for gliomas.

The detection of glioma-specific oncogenic processes, by liquid biopsy, in peripheral blood (ctDNA) could improve diagnosis and follow-up and then avoid surgery for patients with suspected lesions.

Three oncogenic markers can be used to detect gliomas: IDH mutation, TERT mutation, and a marker correlated with ATRX loss on total blood cells.

We hypothesized that the circTeloDIAG will improve and accelerate the diagnostic/prognostic value of the actual classification and provide a new tool to manage patient response to treatment via liquid biopsy. It will combine detection of three markers in liquid biopsy, to produce a versatile tool for all types of gliomas.

Patients with suspected newly diagnosed or recurrent glioma will be included.


Condition or disease Intervention/treatment
Glioma Biological: ctDNA analysis

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The circTeloDIAG: a New Approach of Liquid Biopsy for the Diagnosis and Follow-up of Patients With Glioma Tumor
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
Diagnosis Biological: ctDNA analysis
ctDNA analysis of patients with suspected primary glioma tumors and in patients with suspected recurrence.

Relapse Biological: ctDNA analysis
ctDNA analysis of patients with suspected primary glioma tumors and in patients with suspected recurrence.




Primary Outcome Measures :
  1. ctDNA analysis [ Time Frame: At inclusion ]
    The main objective is to evaluate the performances of the diagnostic test "circTeloDIAG" dedicated to liquid biopsy. Primary endpoint is the sensitivity and specificity of the circTeloDIAG assay, at time of initial surgery. It will be established in CTCs in comparison with tumoral with positivity of one of the three markers tested


Biospecimen Retention:   Samples With DNA
ctDNA of blood's patient with glioma tumour


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected glioma and patients with suspected recurrent glioma
Criteria

Inclusion Criteria:

  • Adult patient
  • Obtainment of written informed consent
  • Suspected newly or recurrent glioma (grade ≥ II) on MRI
  • Patient eligible for surgery (biopsy or resection)
  • Decision of surgery (biopsy or resection) at neuro-oncology interdisciplinary tumor board

Exclusion Criteria:

  • Rejection of consent by patient
  • Hemoglobin < 7g/dl
  • Rejection of surgery by patient
  • Suspected grade I tumor on MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04931732


Contacts
Layout table for location contacts
Contact: GARNIER Louis, Dr +33 (0)4 72 68 13 59 louis.garnier@chu-lyon.fr
Contact: Delphine PONCET, Dr +33 (0)4 27 85 57 34 delphine.poncet@chu-lyon.fr

Locations
Layout table for location information
France
East Group Hospital, Hospices Civils de Lyon Recruiting
Bron, France, 69677
Contact: GARNIER Louis, Dr    +33 (0)4 72 68 13 59    louis.garnier@chu-lyon.fr   
Contact: PONCET Delphine, DR    +33 (0)4 27 85 57 34    delphine.poncet@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04931732    
Other Study ID Numbers: 69HCL20_0461
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
liquid biopsy
glioma
pseudoprogression
relapse
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue