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

NCT05157594 | Completed DMC

• 1 other identifier: 2021-A01907-34
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Glial Cell Tumors

Keywords

Glial Cell Tumors; Progastrin; hPG80

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• hPG80 concentration according to tumor progression

  Through study completion, an average of 1 year and 6 months

• Sensitivity of hPG80 concentration changes to irradiation

  Through study completion, an average of 1 year and 6 months

• Interindividual variations of hPG80 concentration

  Through study completion, an average of 1 year and 6 months

Study Arms (1)

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

Interventions

Blood sample BIOLOGICAL

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.

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Jean Perrin: lead
• ECS Progastrin: collaborator

Study Sites (1)

Centre Jean PERRIN

Clermont-Ferrand, 63011, France

Location

Related Publications (1)

• Casile M, Passildas J, Vire B, Molnar I, Durando X. hPG80 (circulating progastrin) as a blood biomarker for high-grade glial tumors: A pilot study. Front Neurol. 2023 Jan 11;13:1073476. doi: 10.3389/fneur.2022.1073476. eCollection 2022.

  PMID: 36712425 DERIVED

MeSH Terms

Conditions

Glioma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Xavier DURANDO, Pr

  Centre Jean Perrin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: December 15, 2021
• Study Start: February 14, 2022
• Primary Completion: August 19, 2025
• Study Completion: August 19, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)