CClinicalTrials.gg
Status unknownNCT04194593TELOGNOSTICUpdated Dec 11, 2019

Biomarker-based Algorithm for Diagnosis of Glioma

An observational study in Glioma, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-11.

Sponsored by Hospices Civils de Lyon · Observational

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
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Study summary

ATRX (X-linked mental retardation and alpha-thalassaemia syndrome protein) loss and pTERT (Telomerase reverse transcriptase) mutation are diagnostic markers of gliomas. However, 4 to 28% of gliomas shows none of these alterations. The aim of this project is to propose a new test able to detect the telomeric status for every glioma. Based on this test and other markers (such as mutation of IDH1 (isocitrate dehydrogenase 1) and IDH2 (isocitrate dehydrogenase 2)), investigators propose an algorithm, able to classify the main subtypes of gliomas (astrocytoma, oligodendroglioma and glioblastoma).

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Conditions studied

  • Glioma

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In context

Glioma

1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.

This study's enrollment of 300 is above the median of 88 across 238 observational studies indexed under Glioma.

Browse Glioma studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

300 samples of gliomas (FFPE and/or frozen tissues)

Inclusion criteria

  • Patient with a diagnosis of glioma (retrospective),
  • Patient with available biological material : extracted DNA and/or FFPE tissue and/or frozen sample.
  • Samples are not required any more for diagnosis purpose
  • Patient with informed consent

Exclusion criteria

Exclusion Criteria:

  • Patient with no informed consent
  • Patients with no available biological sample
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
300 participants (actual)
Patient registry
No

Groups and cohorts

  • Glioma

    FFPE (Formalin-Fixed Paraffin-Embedded) or frozen samples will be used for DNA extraction. Different gliomas tumors will be used (oligodendroglioma, astrocytomas, glioblastoma)

    Other: PCR (Polymerase Chain Reaction)

Interventions

  • OtherPCR (Polymerase Chain Reaction)

    Biological testing of FFPE (Formalin-Fixed Paraffin-Embedded) or frozen samples of tumors will be led. These tissues have been collected during the treatment of patients (for diagnostic purposes). A molecular analysis (polymerase chain reaction) is led on DNA extracted from FFPE/frozen conserved tissues, and a result is produced by the algorithm.

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What researchers measure

Primary outcomes

  1. Determination of the prognosis and diagnosis values of a new qPCR (quantitative polymerase chain reaction) -based biological testing in glioma

    An algorithm will be built, based on the result of this specific biological testing combined with other markers (determined in routine clinical testing). The algorithm parameters will be set using samples with a clear diagnosis (concordant molecular and immuno-histological markers). Then gliomas with uncertain diagnosis will be classified and the global overall survival will be predicted. Biological testing will be performed during one year and the analyses in terms of disease outcome will be refreshed every year.

    Time frame: 1 year

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Study locations

1 site
  • Institut de Pathologie Est, Biopathologie moléculaire, Hôpitaux Est, HCL
    Bron, 69677, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04194593
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Dec 11, 2019
Start date
Dec 1, 2018
Primary completion
Mar 1, 2020 (estimated)
Completion
Mar 1, 2021 (estimated)
Last update
Dec 11, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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