Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT04256616
Status:
UNKNOWN
Last Update Posted:
2020-07-07
First Post:
2020-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunogenic Cell Death as a Novel Mechanism of Mitomycin C Activity in Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-04', 'studyFirstSubmitDate': '2020-02-03', 'studyFirstSubmitQcDate': '2020-02-03', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MMC-induced ICD', 'timeFrame': '3 years', 'description': 'The main aim of this study is to evaluate whether MMC is able to trigger ICD in patient-derived neoplastic tissues.'}], 'secondaryOutcomes': [{'measure': 'ICD signature analyzed by RNAseq analysis', 'timeFrame': '3 years', 'description': "Identify an expression profile that is common to all tumors that undergo ICD upon MMC treatment ('ICD signature')"}, {'measure': 'Microbiota study', 'timeFrame': '3 years', 'description': 'Verify the existance of urinary microbiome using catheterized urines and identify changes in urinary microbiome composition correlating with bldder cancer, MMC efficacy and staging/progression of the disease'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Cancer']}, 'referencesModule': {'references': [{'pmid': '33408185', 'type': 'DERIVED', 'citation': 'Oresta B, Pozzi C, Braga D, Hurle R, Lazzeri M, Colombo P, Frego N, Erreni M, Faccani C, Elefante G, Barcella M, Guazzoni G, Rescigno M. Mitochondrial metabolic reprogramming controls the induction of immunogenic cell death and efficacy of chemotherapy in bladder cancer. Sci Transl Med. 2021 Jan 6;13(575):eaba6110. doi: 10.1126/scitranslmed.aba6110.'}]}, 'descriptionModule': {'briefSummary': 'The principal objective of this study consists in the assessment of Immunogenic Cell Death (ICD) induction in neoplastic tissues derived from bladder cancer patients treated ex vivo with Mitomycin C (MMC). The evaluation is performed using cellular and molecular analyses of treated versus untreated samples derived from the same patient', 'detailedDescription': "Urothelial or transitional cell carcinoma of the bladder is the fourth most common cancer in males worldwide, with about 60-80% of newly diagnosed patients having non-muscle-invasive bladder cancer (NMIBC). NMIBC management consist in transurethral resection of bladder tumor (TURBT) followed by adjuvant intravesical treatment with the chemotherapeutic agent Mitomycin C (MMC) or the immunotherapy bacillus Calmette-Guérin. These therapies result in low progression rates, but are not efficacious in all patients, leading to high tumor recurrence. Immunogenic cell death (ICD) may be one of the mechanisms of action of MMC intravesical therapy in bladder cancer.\n\nThe primary objective of the study is to evaluate whether MMC is able to trigger ICD in patient-derived neoplastic tissues. As secondary targets we aim to:\n\n1. identify an expression profile that is common to all tumors that undergo ICD upon MMC treatment ('ICD signature'),\n2. asses the genetic and environmental factors- urinary microbiome composition- responsible for MMC treatment efficacy,\n3. evaluate whether ICD induction correlates with clinical staging and response (clinical endpoints for MMC-treated patients are recurrence at three month and one year after enrollment)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '80 patients with carcinoma of the bladder; divided in 20 patients Ta (low grade), 20 patients Ta/T1 (high grade) and 20 patients T2. Only for liquid samples collection we will include 20 CIS (carcinoma in situ) patients.\n\n30 age and sex-matched subjects not suffering from carcinoma of the bladder, already hospitalized in ICH; we expect to enroll 24 males and 6 females of which 10 of 40- 60 years old, 10 of 60-70 years old, 10 of \\>70 years old.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Male and females, \\> 40 years old\n\nFor bladder cancer patients:\n\n\\- bladder cancer patients- patinets with first tumor occurrence or patient with a recurrence after more than 2 years from the removal of the prior malignancy\n\nExclusion Criteria:\n\n* Treated with immunomodulatory agents at time of enrollment or in the two months before enrollment\n* Treated with antibiotics at time of enrollment or during the month before enrollment\n* Positive history of sexually transmitted diseases\n* Urinary infection ongoing or recent (during the three months before enrollment)\n* Suffering from chronic intestinal inflammation\n\nONLY for controls:\n\n* Treated with immunomodulatory agents at time of enrollment or in the two months before enrollment\n* Treated with antibiotics at time of enrollment or during the month before enrollment\n* Positive history of sexually transmitted diseases\n* Urinary infection ongoing or recent (during the three months before enrollment)\n* Suffering from chronic intestinal inflammation'}, 'identificationModule': {'nctId': 'NCT04256616', 'acronym': 'ICH-MIM-01', 'briefTitle': 'Immunogenic Cell Death as a Novel Mechanism of Mitomycin C Activity in Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'Immunogenic Cell Death as a Novel Mechanism of Mitomycin C Activity in Bladder Cancer', 'orgStudyIdInfo': {'id': '2041'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bladder cancer patients', 'description': '80 patients with carcinoma of the bladder; divided in 20 patients Ta (low grade), 20 patients Ta/T1 (high grade) and 20 patients T2. Only for liquid samples collection we will include 20 CIS (carcinoma in situ) patients', 'interventionNames': ['Other: This is an observational study that does not concern a direct intervention on patients and control subjects and does not interfere with the clinical management of patients.']}, {'label': 'Controls- Healthy subjects', 'description': '30 age and sex-matched subjects not suffering from carcinoma of the bladder, already hospitalized in ICH; we expect to enroll 24 males and 6 females of which 10 of 40- 60 years old, 10 of 60-70 years old, 10 of \\>70 years old.', 'interventionNames': ['Other: This is an observational study that does not concern a direct intervention on patients and control subjects and does not interfere with the clinical management of patients.']}], 'interventions': [{'name': 'This is an observational study that does not concern a direct intervention on patients and control subjects and does not interfere with the clinical management of patients.', 'type': 'OTHER', 'description': 'urine collection: DNA is isolated from urine samples (catheterized, washout, midstream) and the 16S rRNA gene is sequenced.\n\nSpecimen collection: Specimens collected during TURBT are selected by a pathologist and trasferred to the laboratory. The tissues are treated ex vivo with MMC.', 'armGroupLabels': ['Bladder cancer patients', 'Controls- Healthy subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Rescigno, PhD', 'role': 'CONTACT', 'email': 'maria.rescigno@hunimed.eu', 'phone': '+390282245431'}], 'facility': 'Humanitas reseach hospital (ICH)', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'centralContacts': [{'name': 'Maria Rescigno, PhD', 'role': 'CONTACT', 'email': 'maria.rescigno@hunimed.eu', 'phone': '+390282245431'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Research outcome'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Clinical Research', 'investigatorFullName': 'Michele Tedeschi', 'investigatorAffiliation': 'Istituto Clinico Humanitas'}}}}