Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-04 @ 7:08 PM
Study NCT ID:
NCT02838433
Status:
UNKNOWN
Last Update Posted:
2016-07-20
First Post:
2016-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Anti-telomerase T CD4 Immunity in Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'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': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-19', 'studyFirstSubmitDate': '2016-07-18', 'studyFirstSubmitQcDate': '2016-07-19', 'lastUpdatePostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of spontaneous UCP-specific Th1 responses measured by ELISPOT assay', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Melanoma']}, 'descriptionModule': {'briefSummary': 'The impressive clinical responses obtained with immune checkpoint inhibitors (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune response might be required for their efficacy and highlight the critical role of antitumor T cell immunity.\n\nRecent progresses on the field of tumor immunology underline the critical role of CD4 helper 1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity. Therefore, monitoring tumor specific TH1 response could be relevant in cancer patients.\n\nIn order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the investigators team have previously described novel promiscuous peptides (referred as UCP: Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared tumor antigen.\n\nBy using UCP-based immuno-assay, UCP specific Th1 immune responses will be evaluated in this study in melanoma before and after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with melanoma, any stade, without history of anti-cancer treatment (surgery, chemotherapy, targeted therapy, immunotherapy...) except for patients with stade IV melanoma for which immunotherapy or targeted therapy is considered. In this case, a first-line chemotherapy treatment is allowed\n* written informed consent\n\nExclusion Criteria:\n\n* patient with immunosuppressive treatment\n* active autoimmune diseases, HIV, hepatitis C or B virus\n* patients under guardianship, curatorship or under the protection of justice, pregnant women'}, 'identificationModule': {'nctId': 'NCT02838433', 'acronym': 'LyTéloMel', 'briefTitle': 'Study of Anti-telomerase T CD4 Immunity in Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Study of Anti-telomerase T CD4 Immunity in Melanoma: Predictive Biomarker and Implications for Immunotherapy', 'orgStudyIdInfo': {'id': 'T/2011/03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biological samples', 'description': 'Blood samples will be collected :\n\n* at baseline,\n* 6 months after the first-line therapy or at disease progression (if occurs first).\n\nIn particular case of patient with immunotherapy or targeted therapy, 3 blood samples will be collected :\n\n* at baseline\n* 3 months after the initiation of immunotherapy or targeted therapy\n* at disease progression Tumor tissues will be collected if available.', 'interventionNames': ['Other: biological samples']}], 'interventions': [{'name': 'biological samples', 'type': 'OTHER', 'description': 'blood and tissue samples', 'armGroupLabels': ['Biological samples']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François AUBIN, Pr', 'role': 'CONTACT'}, {'name': 'François AUBIN, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Régional Universitaire de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'François AUBIN, Pr', 'role': 'CONTACT', 'email': 'faubin@chu-besancon.fr'}, {'name': 'Olivier ADOTEVI, Pr', 'role': 'CONTACT', 'email': 'olivier.adotevi@univ-fcomte.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}