[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100445135":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":33,"studyPopulation":34,"armGroups":35,"interventions":61,"overallOfficials":67,"centralContacts":71,"locations":80,"responsibleParty":99,"collaborators":103,"id":106,"slug":16,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":16,"enrollmentInfo":114,"targetDuration":16,"studyType":117,"phases":16,"briefSummary":118,"conditions":119,"keywords":16,"overallStatus":83,"whyStopped":16,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"University of Manchester","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Feasibility of obtaining paired biopsy samples","To assess the feasibility of obtaining tumour samples pre-radiotherapy (diagnostic or fresh) and a second biopsy during or immediately after radiotherapy, or a surgical sample, from patients undergoing standard of care RT.","Within 6-7 weeks of starting radiotherapy",{"measure":14,"description":15,"timeFrame":12},"Collection of matched blood samples","To obtain additional matched blood samples pre-radiotherapy, during or post-radiotherapy, and at the end of radiotherapy for assessment of immune status of peripheral blood in comparison to the intratumoural microenvironment.",null,[18,21,24,27],{"measure":19,"description":20,"timeFrame":12},"Immunohistochemistry analysis of expression markers on tumour tissue","Immunohistochemistry (IHC) analysis of expression markers on tumours pre-radiotherapy and during\u002Fpost radiotherapy",{"measure":22,"description":23,"timeFrame":12},"RNA evaluation of immune signatures","RNA evaluation of immune signatures in tumour tissue and blood pre-radiotherapy and during\u002Fpost radiotherapy",{"measure":25,"description":26,"timeFrame":12},"Analysis of peripheral blood mononuclear cells","Assessment of changes in immune phenotypic markers",{"measure":28,"description":29,"timeFrame":12},"Analysis of plasma proteins, cytokines and chemokines","Analysis of plasma proteins, cytokines and chemokines as biomarkers of immune response",{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":31,"timePerspective":32,"maskingInfo":16},"COHORT","PROSPECTIVE","The purpose of this prospective, non-CTIMP, translational study is to assess the feasibility of achieving paired biopsies for immune analysis in patients across six different cancer types: cervical, rectal, Head and Neck cancer, nodal non-Hodgkin lymphoma, cutaneous lymphoma and cutaneous squamous cell carcinoma\u002F basal cell carcinoma.\n\nAll participants will have a minimum of 1 mandatory biopsy (during\u002Fpost-radiotherapy \\[irradiated site\\]) and the potential to have a pre-treatment biopsy if the archival biopsy does not meet the suitability criteria.\n\nMatched blood samples will be collected from participants at baseline, during\u002Fpost-radiotherapy, and if radiotherapy continues after the on-treatment biopsy is taken, an additional end of treatment blood sample will be collected.\n\nWe aim to recruit 10-20 participants per study arm, with the option to increase numbers in study arms that are recruiting well - a maximum of 120 patients in total will be recruited to the study.","Hospital clinic",[36,41,45,49,53,57],{"label":37,"type":16,"description":38,"interventionNames":39},"Cervical cancer","Cervical cancer patients receiving standard of care radiotherapy",[40],"Procedure: Biopsy and blood sample collection",{"label":42,"type":16,"description":43,"interventionNames":44},"Rectal cancer","Rectal cancer patients receiving standard of care radiotherapy",[40],{"label":46,"type":16,"description":47,"interventionNames":48},"Head and neck cancer","Head and neck cancer patients receiving standard of care radiotherapy",[40],{"label":50,"type":16,"description":51,"interventionNames":52},"nodal non-Hodgkin lymphoma","Patients with nodal NHL receiving standard of care radiotherapy",[40],{"label":54,"type":16,"description":55,"interventionNames":56},"cutaneous lymphoma","Patients with cutaneous lymphoma receiving standard of care radiotherapy",[40],{"label":58,"type":16,"description":59,"interventionNames":60},"cutaneous squamous cell carcinoma and basal cell carcinoma","Patients with cSCC and cBCC receiving standard of care radiotherapy",[40],[62],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":16},"PROCEDURE","Biopsy and blood sample collection","A pre-treatment diagnostic biopsy sample plus 1 mandatory biopsy (during\u002Fpost-radiotherapy \\[irradiated site\\]) will be collected from each participant.\n\nMatched blood samples will be collected from participants at baseline, during\u002Fpost-radiotherapy, and if radiotherapy continues after the on-treatment biopsy is taken, an additional end of treatment blood sample will be collected.",[37,46,42,54,58,50],[68],{"name":69,"affiliation":5,"role":70},"Timothy M Illidge","STUDY_CHAIR",[72,77],{"name":73,"role":74,"phone":75,"phoneExt":16,"email":76},"Lois Gardner","CONTACT","01612008863","lois.gardner@manchester.ac.uk",{"name":78,"role":74,"phone":75,"phoneExt":16,"email":79},"Eleanor Cheadle","eleanor.j.cheadle@manchester.ac.uk",[81],{"facility":82,"status":83,"city":84,"state":16,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Christie NHS Foundation Trust","RECRUITING","Manchester","M20 4BX","United Kingdom","UK",{"type":89,"coordinates":90},"Point",[91,92],-2.23743,53.48095,{"lat":92,"lon":91},[95],{"name":96,"role":74,"phone":97,"phoneExt":16,"email":98},"Catherine Trigwell","01613066088","catherine.trigwell@manchester.ac.uk",{"type":100,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Tim Illidge","Professor of Targeted Therapy and Oncology",[104],{"name":105,"class":6},"The Christie NHS Foundation Trust","100445135",false,"NCT05076500","Investigating the Tumour Immune Response of Radiotherapy","TIMM-RAD","Inclusion Criteria:\n\n* Histologically confirmed cancer, Stage I-IV, in one of the following: Cervical, rectal, nodal Non-Hodgkin lymphoma, cutaneous lymphoma, Head \\& neck cancer\n* Diagnostic\u002Fpre-treatment biopsy confirmed suitable for translational research \\*\n* Performance status - ECOG 0-2 (Refer to appendix 1), ECOG 3 allowed for arm F (unrelated to underlying cancer) as this group of patients often have ECOG 3 due to age and comorbidities.\n* Age ≥ 18; no upper age limit.\n* Participant considered suitable for radiotherapy\n* Before participant registration, written informed consent must be given according to GCP and national regulations.\n\n  \\*Pre-treatment biopsy must be from the gross tumour volume within the planned radiation field and must also:\n* Have been formalin fixed for \\>12h and \\\u003C72h\n* Have tumour tissue and morphology confirmed by H\\&E staining\n* Contain sufficient tumour cells (approximately 100)\n\nExclusion Criteria:\n\n* Participants deemed unsuitable for a biopsy (during or following radiotherapy) in the opinion of the treating oncologist.\n* Participants who have received chemotherapy within 28 days of starting radiotherapy.\n* Participants with intercurrent or past history of hepatitis B, C or human immunodeficiency virus infection if known. A negative test result for hepatitis B, C and HIV infection is required prior to inclusion in the study.","ALL","18 Years",{"count":115,"type":116},120,"ESTIMATED","OBSERVATIONAL","This study aims to investigate immune changes which occur before and following standard radiotherapy in a range of tumour types. We will collect tissue and blood samples before and after radiation treatment from participants across six cancer types: cervical, rectal, Head and Neck cancer, nodal non-Hodgkin lymphoma, cutaneous lymphoma and cutaneous squamous cell carcinoma\u002F basal cell carcinoma.",[120],"Cancer","2025-06-05",{"date":123,"type":124},"2025-06-11","ACTUAL",{"date":126,"type":124},"2021-07-14",{"date":128,"type":116},"2026-08-14",{"name":5,"class":6},1]