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

Glial Cell Tumors Clinical Trial

— PROGLIO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05157594
• Other study ID #: 2021-A01907-34
• Status: Active, not recruiting
• Start date: February 14, 2022
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glial Cell Tumors
• Glioma

Intervention

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.

Locations

Country	Name	City	State
France	Centre Jean PERRIN	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
Centre Jean Perrin	ECS Progastrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of hPG80	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	hPG80 concentration according to tumor progression	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
Secondary	Sensitivity of hPG80 concentration changes to irradiation	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
Secondary	Interindividual variations of hPG80 concentration	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