Glial Cell TumorsPROGLIONCT05157594
hPG80 (Circulating Progastrin) as a Blood Biomarker for High-grade Glial Tumors
An observational study of Glial Cell Tumors, run by Centre Jean Perrin at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glial Cell Tumors
- What is being tested?
- Blood sample
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2022to 19 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of hPG80 (Circulating Progastrin) as a Blood Biomarker for High-grade Glial Tumors
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
- Being tested
- Blood sample
- Keywords
- Glial Cell Tumors, Progastrin, hPG80
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Radiotherapy 1st session to 9 month follow-up
Secondary outcomes (3)
hPG80 concentration according to tumor progression
To study hPG80 concentration according to tumor progression in patients with high-grade brain tumor
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 year and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start14 Feb 2022
- Primary completion19 Aug 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glial Cell TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Collaborators
- ECS Progastrin
- Responsible party
- Sponsor
- Investigators
- Xavier DURANDO, Pr, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157594
- Sponsor's protocol ID
- 2021-A01907-34
- Acronym
- PROGLIO
- Status last verified
- Sep 2025
- First submitted
- 27 Oct 2021
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36712425
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of hPG80 (Circulating Progastrin) as a Blood Biomarker for High-grade Glial Tumors
- ClinicalTrials.gov ID
- NCT05157594
- Acronym / sponsor ID
- PROGLIO / 2021-A01907-34
- Conditions
- Glial Cell Tumors
- Keywords
- Glial Cell Tumors, Progastrin, hPG80
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Collaborators
- ECS Progastrin
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Biological: Blood sampleA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleEvaluation 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. | Biological | All patients |
Primary outcome
Plasma concentrations of hPG80
Time frame: 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.
3 secondary outcomes
hPG80 concentration according to tumor progression
Time frame: Through study completion, an average of 1 year and 6 months
Sensitivity of hPG80 concentration changes to irradiation
Time frame: Through study completion, an average of 1 year and 6 months
Interindividual variations of hPG80 concentration
Time frame: Through study completion, an average of 1 year and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Derived from this study: PubMed 36712425Casile 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier DURANDO, Pr principal investigator
Centre Jean Perrin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glial Cell Tumors, run by Centre Jean Perrin at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of hPG80 (time frame: From Radiotherapy 1st session to 9 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05157594, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.