Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-03 @ 7:24 AM
Study NCT ID:
NCT02840058
Status:
UNKNOWN
Last Update Posted:
2021-08-02
First Post:
2016-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Anti-telomerase T CD4 Immune Responses for Predicting the Effectiveness of Immunotherapies Targeting PD1 / PDL1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-30', 'studyFirstSubmitDate': '2016-07-13', 'studyFirstSubmitQcDate': '2016-07-18', 'lastUpdatePostDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anti-telomerase specific Th1 responses', 'timeFrame': 'up to 12 months after the initiation of anti-PD1/PDL1 therapy', 'description': 'measured by ELISPOT assay'}, {'measure': 'objective response rate', 'timeFrame': 'up to 12 months after the initiation of anti-PD1/PDL1 therapy', 'description': 'according to RECIST v1.1 criteria'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'Recent scientific advances have shown the important role of immune system against cancer. Today, many immunological biotherapy like anti-PD1/PDL-1 are available in cancer treatment and generate durable clinical responses in some patients. The development of tools for monitoring anti-tumor immune responses dynamically is a major challenge to predict the effectiveness of immunotherapies anti-PD-1 and anti-PDL-1.\n\nThus, the objective of our study is to analyse the interest of the monitoring of anti-telomerase T helper 1 (TH1) responses in predicting the efficacy of immunotherapy, using an immunoassay developed by our group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with metastatic or locally advanced cancer candidate to anti-PD1/PDL1 immunotherapy\n* Performance status 0, 1 or 2 on the ECOG scale\n* Written informed consent\n\nExclusion Criteria:\n\n* Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)\n* Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years\n* Active autoimmune diseases, HIV, hepatitis C or B virus\n* Patients with any medical or psychiatric condition or disease,\n* Patients under guardianship, curatorship or under the protection of justice.'}, 'identificationModule': {'nctId': 'NCT02840058', 'acronym': 'ITHER', 'briefTitle': 'Interest of Anti-telomerase T CD4 Immune Responses for Predicting the Effectiveness of Immunotherapies Targeting PD1 / PDL1', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Interest of Anti-telomerase T CD4 Immune Responses for Predicting the Effectiveness of Immunotherapies Targeting PD1 / PDL1', 'orgStudyIdInfo': {'id': 'API/2015/58'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biological samples', 'description': 'Blood samples will be realized specifically to the study at inclusion (baseline before starting anti PD1/PDL1 treatment), and then 1 month, 3 months and 12 months after initiation of anti-PD1/PDL1 treatment.\n\nPeripheral blood mononuclear cells (PBMC) and plasma will be collected.\n\nAvailable tumor tissues will be collected.', 'interventionNames': ['Other: Biological samples', 'Drug: Anti PD1/PDL1 treatment']}], 'interventions': [{'name': 'Biological samples', 'type': 'OTHER', 'description': 'blood and tumor tissue samples', 'armGroupLabels': ['Biological samples']}, {'name': 'Anti PD1/PDL1 treatment', 'type': 'DRUG', 'armGroupLabels': ['Biological samples']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laura MANSI, Dr', 'role': 'CONTACT', 'email': 'lmansi@chu-besancon.fr'}], 'facility': 'University Hospital of Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Laura MANSI, Dr', 'role': 'CONTACT', 'email': 'mansi.laura@gmail.com'}, {'name': 'Christophe BORG, Pr', 'role': 'CONTACT', 'email': 'christophe.borg@efs.sante.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}