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

Study Overview
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Brief Summary
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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).

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

Conditions
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Glial Cell Tumors

Intervention / Treatment
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* Biological: Blood sample


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glial Cell Tumors, Progastrin, hPG80