[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548667":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":12,"centralContacts":17,"locations":27,"responsibleParty":48,"collaborators":7,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":7,"enrollmentInfo":60,"targetDuration":7,"studyType":63,"phases":7,"briefSummary":64,"conditions":65,"keywords":7,"overallStatus":30,"whyStopped":7,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Institute of Cancer Research, United Kingdom","OTHER",null,[9],{"type":6,"name":10,"description":11,"armGroupLabels":7,"otherNames":7},"Sequencing study","Sequencing of tumour samples for microbiome analysis and molecular charcterisation.",[13],{"name":14,"affiliation":15,"role":16},"Johann De-Bono","The Royal Marsden NHS FT\\The Institute of Cancer Research","PRINCIPAL_INVESTIGATOR",[18,23],{"name":19,"role":20,"phone":21,"phoneExt":7,"email":22},"Omobola Fadahunsi","CONTACT","0203 437 3500","bola.fadahunsi@icr.ac.uk",{"name":24,"role":20,"phone":25,"phoneExt":7,"email":26},"Sasha Gayle","0208 722 4672","sasha.gayle@icr.ac.uk",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Institute of Cancer Research\u002FRoyal Marsden NHS FT","RECRUITING","Sutton","Surrey","SM2 5PT","United Kingdom","UK",{"type":37,"coordinates":38},"Point",[39,40],-0.2,51.35,{"lat":40,"lon":39},[43,46],{"name":14,"role":20,"phone":44,"phoneExt":7,"email":45},"02086426011","Johann.de-Bono@icr.ac.uk",{"name":47,"role":16,"phone":7,"phoneExt":7,"email":7},"Prof. Johann De-Bono",{"type":49,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100548667","microbiome-molecular-charaterisation-100548667",false,"NCT06423976","Microbiome Molecular Charaterisation","Collection of Clinical Material From Patients With Prostate Cancer or Undergoing Investigation for Diagnostic or Follow up Purposes for Molecular Characterisation and Microbiome Analysis","MMC","Inclusion Criteria:\n\n1. Male \\>=18 years.\n2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2.\n3. Undergoing investigation for diagnosis, or with a proven diagnosis of prostate cancer and undergoing further investigation or clinical trial participation.\n4. Patients with tumour deemed by the designated investigator as safely suitable for fresh biopsy AND who are medically fit (according to local practice) to undergo a biopsy or surgical procedure to acquire tumour tissue.\n5. Willing and able to comply with the requirements of the sample collection including fresh tumour biopsy.\n6. The subject is capable of understanding and complying with the protocol requirements and has given written informed consent.\n7. A record of PSA levels within last 3 months.\n\nExclusion Criteria:\n\n1. The presence of any haematological disorders, including coagulation disorders, which would be a contraindication if patient were to undergo a biopsy.\n2. Any psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n3. Presence of any concurrent condition or situation, which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.","MALE","18 Years",{"count":61,"type":62},1000,"ESTIMATED","OBSERVATIONAL","Preclinical models of prostate cancer have proved to be poorly predictive of the behaviour of the disease in patients. This protocol describes the acquisition of prostate cancer tissue or cells from patients with treatment naïve\u002Fhormone-sensitive and castration-resistant prostate cancer or patients undergoing diagnostic or follow up investigations. The knowledge gained will improve the investigators' understanding of the steps leading to the development of castration resistance and identify new molecular targets for treatment.\n\nThe human microbiome has been under investigation in a range of human diseases (i.e. metabolic disease\u002Fobesity, neurological disorders, cardiovascular disease, mental disorders, autoimmune disease, asthma and allergies) and cancer. The human microbiota can have direct (e.g. via direct genotoxicity, induction of chronic inflammation, etc.) and\u002For indirect (e.g. effects on tumour effects on tumour development or progression exerted through microbial communities that exist at a site distant to the tumour) effects on the disease. Emerging data supports the influence of the gut microbiota on the efficacy of anti-cancer treatments, including immunotherapy. To date, the impact of the gut microbiome on prostate cancer therapies is virtually unexplored. Based on the evidence to date, the investigators hypothesize that the gut flora may be altered by certain treatments for advanced prostate cancer, and that the composition of the microbiome in the gastrointestinal tract may be used to predict therapeutic efficacy or therapy-related toxicities; as well as prevent treatment toxicity and\u002For enhance treatment response.\n\nFurthermore, the purpose is to investigate the association between gut flora and treatment response and related toxicities\u002Fmorbidities in advanced prostate cancer.",[66],"Prostate Cancer","2024-05-23",{"date":69,"type":70},"2024-05-24","ACTUAL",{"date":72,"type":70},"2023-10-23",{"date":74,"type":62},"2038-10",{"name":5,"class":6},1]