Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-01 @ 4:55 PM
Study NCT ID:
NCT04487457
Status:
COMPLETED
Last Update Posted:
2023-04-06
First Post:
2020-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-05', 'studyFirstSubmitDate': '2020-07-16', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline blood concentration of regulatory T-lymphocytes (Treg) at 6 months', 'timeFrame': 'Baseline, 3 months and 6 months', 'description': 'Blood concentrations will be measured at specific times'}, {'measure': 'Change from baseline blood concentration of lymphocyte populations T, B, NK, CD4+ and CD8+ (effector T-lymphocytes (Teff) included) at 6 months', 'timeFrame': 'Baseline, 3 months and 6 months', 'description': 'Blood concentrations will be measured at specific times'}], 'secondaryOutcomes': [{'measure': 'Change from baseline blood concentration of anti-inflammatory cytokines at 6 months', 'timeFrame': 'Baseline, 3 months and 6 months', 'description': 'Blood concentrations will be measured at specific times'}, {'measure': 'Assess correlation between blood concentration of Treg, blood concentration of Teff and blood concentration of anti-inflammatory cytokines', 'timeFrame': 'Baseline, 3 months and 6 months'}, {'measure': 'Determination of PDL1 status', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunity checkpoint inhibitor', 'Rescue chemotherapy', 'Non Small Cell Lung Cancer', 'Bladder Cancer'], 'conditions': ['Non Small Cell Lung Cancer', 'Bladder Cancer', 'ENT Cancer']}, 'descriptionModule': {'briefSummary': 'Non-small cell lung cancer (NSCLC) is the most common histological form, accounting for 85% of all bronchopulmonary cancers (PBC). The advent of Immunity Checkpoint Inhibitors (ICIs) targeting Programmed cell Death-1 (PD-1) is changing current treatment algorithms.\n\nPreliminary results from work carried out in the Medical Oncology Department of the University Hospital of Tours suggest that immunotherapy targeting ICI, when administered beforehand, increases the effect of catch-up chemotherapy. In NSCLC, the progression-free survival (PFS) of 3rd line chemotherapy after anti-PD-1 immunotherapy was better than the PFS of 3rd line chemotherapy performed at the end of conventional chemotherapy. Moreover, the combination of chemotherapy and immunotherapy gives paradoxically better results than immunotherapy alone.\n\nImmunotherapy restores the anti-tumor T immunity inhibited by the cancer cell. While the mode of action of ICIs is well known, the mechanisms of resistance to them are poorly understood. Several pathways are evoked, in particular the modulation of cellular interactions within the tumour microenvironment (TME), the molecular expression profile of cancer cells, or the immunological status of the patient.\n\nRegulatory T lymphocytes (Treg) participate in the maintenance of immune system homeostasis by ensuring tolerance to self antigens. Within TME, Treg inhibit anti-tumor T cell activity and potentiate tumor proliferation. The latter, by specifically recognizing tumor antigens, block the activity of effector T lymphocytes directed against tumor cells. Thus, an increase in circulating Treg concentrations and in TME is a poor prognostic factor, especially in NSCLC.\n\nGemcitabine chemotherapy is commonly used in the management of NSCLC. Recent data show that gemcitabine decreases Treg activity and regulates levels of anti-inflammatory TME cytokines such as IL10, TGF-β and interferon-Ɣ.\n\nThe hypothesis of this study is that the decrease in Treg blood concentration by catch-up chemotherapy restores sensitivity to immunotherapy.', 'detailedDescription': 'Non-small cell lung cancer (NSCLC) is the most common histological form, accounting for 85% of all bronchopulmonary cancers (PBC). The advent of Immunity Checkpoint Inhibitors (ICIs) targeting Programmed cell Death-1 (PD-1) is changing current treatment algorithms.\n\nPreliminary results from work carried out in the Medical Oncology Department of the University Hospital of Tours suggest that immunotherapy targeting ICI, when administered beforehand, increases the effect of catch-up chemotherapy. In NSCLC, the the progression-free survival (PFS) of 3rd line chemotherapy after anti-PD-1 immunotherapy was better than the PFS of 3rd line chemotherapy performed at the end of conventional chemotherapy. Moreover, the combination of chemotherapy and immunotherapy gives paradoxically better results than immunotherapy alone.\n\nImmunotherapy restores the anti-tumor T immunity inhibited by the cancer cell. While the mode of action of ICIs is well known, the mechanisms of resistance to them are poorly understood. Several pathways are evoked, in particular the modulation of cellular interactions within the tumour microenvironment (TME), the molecular expression profile of cancer cells, or the immunological status of the patient.\n\nRegulatory T lymphocytes (Treg) participate in the maintenance of immune system homeostasis by ensuring tolerance to self antigens. Within TME, Treg inhibit anti-tumor T cell activity and potentiate tumor proliferation. The latter, by specifically recognizing tumor antigens, block the activity of effector T lymphocytes directed against tumor cells. Thus, an increase in circulating Treg concentrations and in TME is a poor prognostic factor, especially in NSCLC.\n\nGemcitabine chemotherapy is commonly used in the management of NSCLC. Recent data show that gemcitabine decreases Treg activity and regulates levels of anti-inflammatory TME cytokines such as IL10, TGF-β and interferon-Ɣ.\n\nThe hypothesis of this study is that the decrease in Treg blood concentration by catch-up chemotherapy restores sensitivity to immunotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is patients receiving chemotherapy alone after immunotherapy for NSCLC or bladder cancer or ENT cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patients treated with immune checkpoint inhibitor alone or in combination with chemotherapy in 1st or 2nd line\n* Patient with locally advanced or metastatic Non-Small-Cell Lung Cancer, or bladder cancer or Ear Nose Throat cancer\n* Maximum delay of 2 months between ICI and chemotherapy\n\nExclusion Criteria:\n\n* Symptomatic brain metastases\n* Corticotherapy \\> 10 mg/day\n* Active auto-immune disease\n* Oncogenic addiction\n* Data processing objection'}, 'identificationModule': {'nctId': 'NCT04487457', 'acronym': 'CINECI', 'briefTitle': 'Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': "Étude Prospective d'évaluation de la cinétique Sanguine de Cellules Immunitaires et de Cytokines Immunosuppressives après Exposition à un Inhibiteur Des Checkpoints de l'immunité (ICI) : étude de l'Impact de la chimiothérapie", 'orgStudyIdInfo': {'id': 'RIPH3-RNI20 / CINECI'}, 'secondaryIdInfos': [{'id': '2020-A01478-31', 'type': 'OTHER', 'domain': 'IdRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer', 'description': 'Patients receiving chemotherapy alone after immunotherapy for NSCLC or bladder cancer or ENT cancer', 'interventionNames': ['Other: Blood samples']}], 'interventions': [{'name': 'Blood samples', 'type': 'OTHER', 'description': 'Blood samples', 'armGroupLabels': ['Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Medical oncology department, University Hospital, Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Pneumology department, University Hospital, Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}