Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT05157594
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2021-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
hPG80 (Circulating Progastrin) as a Blood Biomarker for High-grade Glial Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2021-10-27', 'studyFirstSubmitQcDate': '2021-12-01', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentrations of hPG80', 'timeFrame': 'From Radiotherapy 1st session to 9 month follow-up', 'description': 'To evaluate plasma concentrations of hPG80 (circulating progastrin) during therapeutic and recurrence follow-up in patients with high-grade brain tumors.'}], 'secondaryOutcomes': [{'measure': 'hPG80 concentration according to tumor progression', 'timeFrame': 'Through study completion, an average of 1 year and 6 months', 'description': 'To study hPG80 concentration according to tumor progression in patients with high-grade brain tumor'}, {'measure': 'Sensitivity of hPG80 concentration changes to irradiation', 'timeFrame': 'Through study completion, an average of 1 year and 6 months', 'description': 'To evaluate the sensitivity of hPG80 concentration changes to irradiation in patients with high-grade brain tumor.'}, {'measure': 'Interindividual variations of hPG80 concentration', 'timeFrame': 'Through study completion, an average of 1 year and 6 months', 'description': 'To compare the plasma expression level of hPG80 in patients with high-grade brain tumor to study interindividual variations around and during disease management.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glial Cell Tumors', 'Progastrin', 'hPG80'], 'conditions': ['Glial Cell Tumors']}, 'referencesModule': {'references': [{'pmid': '36712425', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female or male 18 years of age or older.\n* Patients with a high grade primary glial tumor (Astrocytoma grade 3; Glioblastoma; Anaplastic Oligodendroglioma)\n* Patients scheduled to begin radiation and/or chemotherapy.\n* Able to give informed consent to participate in the research.\n* Enrolled in a social security plan or beneficiary of such a plan.\n\nExclusion Criteria:\n\n* Patient under guardianship or curatorship\n* 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.\n* Refusal to participate.\n* Pregnant or breastfeeding woman.'}, 'identificationModule': {'nctId': 'NCT05157594', 'acronym': 'PROGLIO', 'briefTitle': 'hPG80 (Circulating Progastrin) as a Blood Biomarker for High-grade Glial Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Centre Jean Perrin'}, 'officialTitle': 'Pilot Study of hPG80 (Circulating Progastrin) as a Blood Biomarker for High-grade Glial Tumors', 'orgStudyIdInfo': {'id': '2021-A01907-34'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All patients', 'description': '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.', 'interventionNames': ['Biological: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['All patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Jean PERRIN', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Xavier DURANDO, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Jean Perrin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Jean Perrin', 'class': 'OTHER'}, 'collaborators': [{'name': 'ECS Progastrin', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}