hPG80 (Circulating Progastrin) as a Blood Biomarker for High-grade Glial Tumors (PROGLIO)

September 17, 2025 updated by: Centre Jean Perrin

Pilot Study of hPG80 (Circulating Progastrin) as a Blood Biomarker for High-grade Glial Tumors

PROGLIO is a French mono-centric study with longitudinal follow-up, in which patients with high grade brain tumors will be included. Blood samples will be taken during their therapeutic follow-up to evaluate plasma concentrations of hPG80 (circulating progastrin).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Female or male, 18 years of age or older, with a primary high-grade glial tumor (Astrocytoma Grade 3; Glioblastoma; Anaplastic Oligodendroglioma) who needs to initiate radiation and/or chemotherapy.

Description

Inclusion Criteria:

  • Female or male 18 years of age or older.
  • Patients with a high grade primary glial tumor (Astrocytoma grade 3; Glioblastoma; Anaplastic Oligodendroglioma)
  • Patients scheduled to begin radiation and/or chemotherapy.
  • Able to give informed consent to participate in the research.
  • Enrolled in a social security plan or beneficiary of such a plan.

Exclusion Criteria:

  • Patient under guardianship or curatorship
  • Psychological disorder (cognitive disorders, vigilance disorders, etc.) or social reasons (deprivation of liberty by judicial or administrative decision) or geographical reasons that could compromise the medical follow-up of the trial.
  • Refusal to participate.
  • Pregnant or breastfeeding woman.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All patients
A fasting blood sample will be taken on the day of the beginning and the day of the end of the radiotherapy and during the adjuvant chemotherapy (every 3 cycles). A follow-up will be performed for 9 months, with a blood sample taken every three months on the day of the follow-up MRI.
Biological: Blood sample
Evaluation of plasma hPG80 concentrations by fasting blood samples. A total of seven 5 mL blood samples will be taken: Before radiation therapy; at the end of radiation therapy; at cycle 3 of chemotherapy; at cycle 6 of chemotherapy; 3 months after the end of treatment; 6 months after the end of treatment; and 9 months after the end of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma concentrations of hPG80
Time Frame: From Radiotherapy 1st session to 9 month follow-up
To evaluate plasma concentrations of hPG80 (circulating progastrin) during therapeutic and recurrence follow-up in patients with high-grade brain tumors.
From Radiotherapy 1st session to 9 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hPG80 concentration according to tumor progression
Time Frame: Through study completion, an average of 1 year and 6 months
To study hPG80 concentration according to tumor progression in patients with high-grade brain tumor
Through study completion, an average of 1 year and 6 months
Sensitivity of hPG80 concentration changes to irradiation
Time Frame: Through study completion, an average of 1 year and 6 months
To evaluate the sensitivity of hPG80 concentration changes to irradiation in patients with high-grade brain tumor.
Through study completion, an average of 1 year and 6 months
Interindividual variations of hPG80 concentration
Time Frame: Through study completion, an average of 1 year and 6 months
To compare the plasma expression level of hPG80 in patients with high-grade brain tumor to study interindividual variations around and during disease management.
Through study completion, an average of 1 year and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Jean Perrin

Collaborators

ECS Progastrin

Investigators

  • Principal Investigator: Xavier DURANDO, Pr, Centre Jean Perrin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2022

Primary Completion (Actual)

August 19, 2025

Study Completion (Actual)

August 19, 2025

Study Registration Dates

First Submitted

October 27, 2021

First Submitted That Met QC Criteria

December 1, 2021

First Posted (Actual)

December 15, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A01907-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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