Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
Study NCT ID:
NCT07255157
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-11-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peripheral Helper T-cells in Common Variable ImmunoDeficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017074', 'term': 'Common Variable Immunodeficiency'}], 'ancestors': [{'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-11-19', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability of Tph to promote differentiation and antibody production by memory B cells (B-T co-culture)', 'timeFrame': 'At baseline (Day 0)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['common variable immunodeficiency', 'peripheral helper T cells', 'B cells'], 'conditions': ['Common Variable Immunodeficiency']}, 'descriptionModule': {'briefSummary': 'The aim is to determine whether whether Tph could support non-infectious complications through providing help to pathological B-cells.', 'detailedDescription': 'Common variable immunodeficiency (CVID), the most common symptomatic primary immunodeficiency in adults, can associate recurrent infections with severe non-infectious complications. Unfortunately, there is still no absolute biomarker predicting which CVID patient will develop non-infectious complications. Thus, novel biomarkers which could help refining CVID patient prognosis require further investigations. Moreover, the immune mechanisms driving non-infectious complications remain elusive. Therefore, further insight into CVID pathophysiology is needed to discover new treatments for CVID patients with non-infectious complications (CVIDc). The preliminary results show that CVIDc patients have an increase of circulating peripheral helper T-cells (Tph) , in comparison with patients with infectious manifestations only (CVIDi) and healthy individuals (HI). Recently described, Tph express CXCR3, help memory B-cells and are found in inflamed tissues in auto-immune diseases. They represent a major reservoir of auto-reactive T-cells, suggesting that Tph are key to drive auto-immune processes. Some authors hypothesized that Tph can help atypical memory B-cells (ABCs), a B-cell subset which is involved in auto-immune disease pathophysiology and which is also expanded in CVIDc patients. The investigators observed that CXCR3+ cells were increased in the spleen of CVIDc patients in comparison with non-CVID controls. These CXCR3+ cells could correspond to Tph supporting extra-follicular reaction and then B-cell tolerance loss. The hypothesis is that alterations in T-B cell collaboration leads to the amplification of Tph in CVID patients. Tph could support non-infectious complications in target tissues through providing help to pathological B-cells such as ABCs. Using peripheral blood from CVIDc/CVIDi patients and HI, the investigators will determine whether Tph support pathological B cell activation in CVIDc patients using T-B co-cultures. Patients will be included during their routine follow-up, for one day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female;\n* Age ≥ 18 years;\n* Standard criteria will be applied to diagnose CVID, specifically requiring: 1) low serum IgG level \\<5 g/L, combined with low IgM- and/or IgA-isotype concentrations \\<0.4 g/L or \\<0.7 g/L, respectively; 2) poor antibody responses to immunization or infection; and 3) exclusion of other defined forms of secondary hypogammaglobulinemias. Patients meeting the definitional criteria for CVID will be included, regardless of the duration of the disease or the treatment received (gammaglobulins substitution or not);\n* Being affiliated to health insurance;\n* Willing to participate and to sign informed consent.\n\nExclusion Criteria:\n\n* Patients on corticosteroids and/or immunosuppressants;\n* Patients with a primary immunodeficiency genetically characterized, such as Bruton disease our HyperIgM syndrome;\n* Patients with an active chronic infection;\n* Pregnant or breastfeeding women;\n* Persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent.'}, 'identificationModule': {'nctId': 'NCT07255157', 'acronym': 'TAPDI', 'briefTitle': 'Peripheral Helper T-cells in Common Variable ImmunoDeficiency', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Deciphering the Role of Peripheral Helper T-cells in Common Variable ImmunoDeficiency Pathophysiology in Patients With Non-infectious Complications', 'orgStudyIdInfo': {'id': 'CHUBX 2025/037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Common variable immunodeficiency', 'interventionNames': ['Other: blood sample']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Controls', 'description': 'Healthy controls', 'interventionNames': ['Other: blood sample']}], 'interventions': [{'name': 'blood sample', 'type': 'OTHER', 'description': '48 ml whole blood for Peripheral blood mononuclear cell (PBMC) and serum isolation', 'armGroupLabels': ['Common variable immunodeficiency', 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pessac', 'country': 'France', 'contacts': [{'name': 'Jean-François VIALLARD, Prof', 'role': 'CONTACT', 'email': 'jean-françois.viallard@chu-bordeaux.fr', 'phone': '(0)5.57.65.64.83', 'phoneExt': '+33'}, {'name': 'Carine LOPEZ', 'role': 'CONTACT', 'email': 'carine.lopez@chu-bordeaux.fr', 'phone': '(0)5.24.54.91.32', 'phoneExt': '+33'}, {'name': 'Jean-François VIALLARD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Estibaliz LAZARO, Prof', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carine GREIB, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Camille PROT-LEURENT, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pierre DUFFAU, Prof', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Emmanuel RIBEIRO, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Bordeaux - service de médecine interne', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}], 'centralContacts': [{'name': 'Jean-François VIALLARD, Prof', 'role': 'CONTACT', 'email': 'jean-françois.viallard@chu-bordeaux.fr', 'phone': '(0)5.57.65.64.83', 'phoneExt': '+33'}, {'name': 'Carine LOPEZ', 'role': 'CONTACT', 'email': 'carine.lopez@chu-bordeaux.fr', 'phone': '(0)5.24.54.91.32', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Jean-François VIALLARD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}, {'name': 'Jonathan VISENTIN, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}