PROGLIO: hPG80 (Circulating Progastrin) as a Blood Biomarker for High-grade Glial Tumors
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female or male 18 years of age or older.
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Patients with a high grade primary glial tumor (Astrocytoma grade 3; Glioblastoma; Anaplastic Oligodendroglioma)
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Patients scheduled to begin radiation and/or chemotherapy.
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Able to give informed consent to participate in the research.
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Enrolled in a social security plan or beneficiary of such a plan.
Exclusion Criteria:
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Patient under guardianship or curatorship
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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.
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Refusal to participate.
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Pregnant or breastfeeding woman.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Jean PERRIN | Clermont-Ferrand | France | 63011 |
Sponsors and Collaborators
- Centre Jean Perrin
- ECS Progastrin
Investigators
- Principal Investigator: Xavier DURANDO, Pr, Centre Jean Perrin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-A01907-34