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

Active, not recruiting

• Conditions: Glial Cell Tumors
• Interventions: Biological: Blood sample

• Registration Number: NCT05157594
• Lead Sponsor: Centre Jean Perrin

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-15
• Study Start: 2022-02-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-08
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients	Blood sample	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.

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of hPG80	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.

Secondary Outcome Measures

Name	Time	Method
Sensitivity of hPG80 concentration changes to irradiation	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.
Interindividual variations of hPG80 concentration	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.
hPG80 concentration according to tumor progression	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

Trial Locations

Locations (1)

Centre Jean PERRIN; 🇫🇷 Clermont-Ferrand, France