protocolSection identificationModule nctId: NCT06299800, orgStudyIdInfo id: CE385/2023, briefTitle: Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer, acronym: TCPT2023, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-04, primaryCompletionDateStruct date: 2025-02-04, completionDateStruct date: 2025-02-04, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliero Universitaria Maggiore della Carita, class: OTHER, descriptionModule briefSummary: Recent research has highlighted the significant relationship between type 2 diabetes mellitus and cancer, both prevalent and impactful on global health. The intrinsic correlation arises from shared metabolic processes, particularly a systemic and chronic inflammatory state driven by factors like obesity, dyslipidemia, and hyperglycemia. This leads to the creation of a self-sustaining microenvironment known as meta-inflammation, promoting cancer development through DNA damage, oxidative stress, and the influence of hormones like leptin. The hyperglycemic environment in diabetes contributes to cancer development, supporting the Warburg effect and insulin-related mechanisms. This study aims to identify risk factors associated with diabetes that impact tumor development and progression, crucial for guiding effective preventive strategies in clinical practice.Primary objective of the study:- identify the risk factors affecting the occurrence of cancer in the population affected by type 2 diabetes mellitus;Secondary objectives of the study:* description of the demographic, clinical and first-line therapy characteristics of patients diagnosed with type 2 diabetes mellitus;* assess risk factors for recurrence, presence of a second tumour not related to the first and the presence of both events in patients who have had a tumor within 10 years of diagnosis of diabetes;* assess the relationship between the characteristics of patients and the time to the onset of cancer., conditionsModule conditions: Diabetes Mellitus, Type 2, conditions: Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 779, type: ESTIMATED, armsInterventionsModule interventions name: phenotyping of patients followed at a third-level diabetes centre with cancer, outcomesModule primaryOutcomes measure: Smoking assessment at first visit, primaryOutcomes measure: Alcool consumption at first visit, primaryOutcomes measure: BMI assessment at first visit, primaryOutcomes measure: Glycated assessment at first visit, secondaryOutcomes measure: First-line therapy characteristics assessment at first visit, secondaryOutcomes measure: Primary outcomes and recurrence or presence of a secondary tumor, secondaryOutcomes measure: Relationship between patients characteristics and the time onset of cancer considering anthropometric and biochemical data, secondaryOutcomes measure: Tumour characterization in the considered population, detected at the first clinical visit, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SCDU Endocrinology, AOU Ospedale Maggiore della Carità, status: RECRUITING, city: Novara, zip: 28100, country: Italy, contacts name: Flavia Prodam, role: CONTACT, phone: +39 0321 660 693, email: flavia.prodam@med.uniupo.it, geoPoint lat: 45.44694, lon: 8.62118, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-09-10, uploadDate: 2024-03-01T05:46, filename: Prot_SAP_000.pdf, size: 525402, hasResults: False