[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University Hospitals of Derby and Burton NHS Foundation Trust\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":198},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,51,89,119,146,175],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100599511","audit-of-targeted-sentinel-node-biopsy-tsnb-in-patients-with-limited-nodal-disease-undergoing-primary-surgery-100599511",false,"NCT07085442","Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery","NodeSMART - Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery","NodeSMART","Inclusion Criteria:\n\n* cT1-2N1M0 breast cancer\\*\n* FNA or core biopsy confirmed axillary nodal metastases\n* ≤2 abnormal nodes on imaging\n* Undergo a dual tracer or single tracer sentinel node biopsy along with removal of the marked node (Targeted Sentinel Node Biopsy, TSNB)\n* 1 or 2 macrometastases identified in the removed nodes, with at least three nodes removed\n* If the sentinel node(s) cannot be localised on SNB: axillary node sampling should be performed, the patient will be eligible if 1 or 2 macrometastases are identified in the removed nodes, with at least three nodes removed.\n* If the node is not marked or the marked node is not removed, the patient will be eligible if 1 or 2 macrometastases are identified in the removed nodes, with at least three nodes removed.\n\n  * patients with T3 tumours on post-operative histology will remain eligible.\n\nExclusion Criteria:\n\n* Neoadjuvant chemotherapy\n* Previous ipsilateral axillary lymph node dissection\n* cT3-4 breast cancer\n* ≥3 abnormal nodes on imaging","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","5 Years","OBSERVATIONAL","Axillary ultrasound scan (AUS) is routinely employed in the UK for preoperative axillary staging and can diagnose approximately 50 - 80% of node positive patients when combined with percutaneous needle biopsy techniques (either core-biopsy or fine-needle aspiration cytology). It is recognised that nodal burden is generally higher in clinically node negative patients with abnormal nodes on AUS and confirmed on needle-biopsy to be histologically positive than patients diagnosed as node positive on sentinel node biopsy (SNB). However, up to 40% of biopsy-proven node positive patients are found to have fewer than 3 involved nodes on subsequent axillary lymph node dissection (ALND) and are potential candidates for less extensive axillary surgery with axillary radiotherapy (ART) rather than ALND. The total number of abnormal nodes on ultrasound is a key predictor of overall nodal tumour burden.\n\nThe AMAROS and OTOASOR trials randomised patients with up to 2 positive sentinel nodes to either ALND or ART. These trials were conducted around the turn of the millennium and before routine use of AUS and therefore would have included a significant number of patients who were radiologically node positive (cN1). Likewise, the ACOSOG Z0011 trial that randomised a similar group of patients to either ALND or observation only, did not incorporate routine AUS and would have included some (radiological) cN1 patients. These trials revealed no adverse impact on disease-free or overall survival from omission of completion ALND.\n\nTargeted axillary dissection (TAD) was introduced a few years ago to reduce the false negative rate of SNB following neoadjuvant chemotherapy (NACT) and has been standardised as part of the ongoing ATNEC trial \\[ClinicalTrials.govNCT04109079\\]. This technique for axillary staging after NACT is increasingly being adopted in the UK and elsewhere. TAD is technically more straightforward and less challenging in patients undergoing primary surgery with no concerns about clip migration consequent to nodal shrinkage as part of treatment response to NACT. Furthermore, the risk of under-treating the axilla is offset by the protocol: if no disease is identified in the targeted nodes (false-negative case), then patients proceed to ALND, thereby ensuring adequate treatment. Unlike TAD following NACT, the presence of viable tumour within the sampled nodes is mandatory and finding fibrosis is irrelevant except as a response to nodal biopsy per se.\n\nCurrent ASCO guidelines support both SNB and TAD as staging options for patients with ultrasound-detected, biopsy-confirmed nodal disease. The Edinburgh randomised trials comparing four-node sampling with ALND demonstrated significantly lower arm morbidity with node sampling, supporting TAD as a less morbid appropriate alternative in this patient population.\n\nThe UK-ANZ POSNOC trial randomised 1,900 patients with \\\u003C3 macrometastases to either no further axillary treatment or additional axillary treatment. The study included cN1 patients with biopsy-confirmed nodal metastases who underwent sentinel node biopsy or TAD. Patients with \\\u003C3 macrometastases on final histology were randomised to receive no further axillary treatment or proceed with additional axillary treatment (ALND or ART). POSNOC trial will answer whether further axillary treatment provides any benefit in patients with low volume nodal disease on SNB or TAD.\n\nNotably, patients with biopsy-confirmed metastases and \\\u003C3 macrometastases on SNB\u002FTAD are biologically and clinically similar to patients with normal AUS who are later found to have low-volume disease on SNB. Clinical decision-making and patient outcomes are driven by tumour biology and overall disease burden rather than the method of nodal disease detection. Furthermore, AUS sensitivity is operator dependent and whether FNA or core biopsy was used to sample the node. A patient considered node negative on AUS by one radiologist may be diagnosed with core biopsy confirmed nodal metastases with another radiologist. Pending the results of POSNOC trial, patients with less than 3 macrometastases are generally advised further axillary treatment, and ART is preferred over ALND to reduce the risk of lymphoedema.\n\nNodeSMART is a prospective audit collecting data on patients undergoing TAD in the primary surgery setting. Its goal is to audit surgical outcomes and benchmark them against - a) Comparing technical outcomes with those from sentinel node biopsy in the primary surgery setting and TAD performed after neoadjuvant chemotherapy. b) Assessing rates of arm lymphoedema and disease progression relative to findings from the AMAROS and Z11 trials, and the POSNOC trial once results are available. The term \"Targeted Axillary Dissection\" is somewhat misleading in this context, as the marked (biopsied) node is removed alongside sentinel nodes - not in isolation. NodeSMART therefore refers to the procedure more accurately as Targeted Sentinel Node Biopsy (TSNB).",[26,27,28,29,30,31,32],"Breast Cancer","Axillary Lymph Nodes Dissection","Axillary Metastases","Sentinel Lymph Node Biopsy (SLNB)","Node Positive Breast Cancer","Axilla; Breast","Axillary Ultrasound",[34,35,15,26,36,27,37],"Targeted Axillary Dissection","Targeted Sentinel Node Biopsy","Sentinel Node Biopsy","Axillary Node Clearance","RECRUITING","2026-05-24",{"date":41,"type":42},"2026-05-28","ACTUAL",{"date":44,"type":42},"2025-01-17",{"date":46,"type":21},"2032-12",{"name":48,"class":49},"University Hospitals of Derby and Burton NHS Foundation Trust","OTHER",12,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100370878","axillary-management-in-breast-cancer-patients-with-needle-biopsy-proven-nodal-metastases-after-neoadjuvant-chemotherapy-100370878","NCT04109079","Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy","ATNEC - Axillary Management in T1-3N1M0 Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases at Presentation After Neoadjuvant Chemotherapy","ATNEC","Inclusion Criteria:\n\n* Age ≥ 18\n* Male or female\n* cT1-3N1M0 breast cancer at diagnosis (prior to NACT) as per AJCC 8th edition (see Section 6.4.1)\n\n  o Patients with occult primary invasive breast cancer (no identifiable invasive cancer in the breast) with FNA or core biopsy proven nodal metastases are eligible for the study.\n* FNA or core biopsy confirmed axillary nodal metastases at presentation\n* Oestrogen receptor and HER2 status evaluated on primary tumour\n* Received standard NACT as per local guidelines (Patients undergoing neoadjuvant endocrine therapy as part of another clinical trial are eligible)\n* Imaging of the axilla, as required, to assess response to NACT (per local guidelines)\n* Undergo a dual tracer sentinel node biopsy (SNB) after NACT with at least 3 nodes removed.\n\n  * If a single tracer SNB is performed: the patient is eligible only if the involved node is marked before or during NACT, and at least 3 nodes (including the marked node) are removed during sentinel node biopsy.\n  * If the node is not marked or the marked node is not removed: the patient is eligible only if the histology report shows evidence of down-staging with complete pathological response e.g., fibrosis or scarring in at least one node and at least 3 nodes removed.\n  * If fewer than 3 nodes are found on histology: the patient is eligible only if BOTH points a) and b), below, are met:\n\n    1. involved node was marked and removed during SNB; and\n    2. removed marked node shows evidence of downstaging on histology e.g. fibrosis or scarring.\n* If the sentinel node(s) cannot be localised on SNB: axillary node sampling should be performed, the patient will be eligible if at least 3 nodes are removed.\n* No evidence of nodal metastases post NACT (isolated tumour cells, micro or macro metastasis)\n* Patients with complete pathological response in the axilla but residual disease in the breast post NACT are eligible for the study\n* Patients who are cN0 (node negative) at initial presentation, with a negative sentinel node post NACT showing evidence of treatment response or downstaging will be eligible, provided at least 3 nodes are removed.\n\n5.2. Exclusion Criteria\n\nParticipants will be excluded if they have any one of the following:\n\n* Bilateral synchronous invasive breast cancer\n* Sentinel node biopsy prior to NACT\n* Previous axillary nodal surgery on the same body side as the scheduled targeted sampling\n* Any previous cancer within last 5 years or concomitant malignancy except\n\n  * basal or squamous cell carcinoma of the skin\n  * in situ carcinoma of the cervix\n  * in situ or stage 1 melanoma\n  * contra- or ipsilateral in situ breast cancer\n  * chronic lymphocytic leukaemia not on treatment",{"count":60,"type":21},1900,"INTERVENTIONAL",[63],"NA","The aim of this study is to assess whether, omitting further axillary treatment (ALND and ART) for patients with early stage breast cancer and axillary nodal metastases on needle biopsy, who after NACT have no residual cancer in the lymph nodes on sentinel node biopsy, is non-inferior to axillary treatment in terms of disease free survival (DFS) and results in reduced risk of lymphoedema at 5 years.",[26,66,67],"Sentinel Lymph Node","Neoplasm, Breast",[69,70,71,72,73,74,75,76,77,78,79],"neoadjuvant chemotherapy","sentinel node biopsy","breast cancer","tattooing node","marking node","clip node","axillary ultrasound","node positive","axillary lymph node dissection","axillary radiotherapy","axillary treatment","2026-03-27",{"date":82,"type":42},"2026-03-30",{"date":84,"type":42},"2021-02-26",{"date":86,"type":21},"2030-02-28",{"name":48,"class":49},98,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":61,"phases":99,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100621967","dialysate-cooling-for-the-preservation-of-cognitive-function-in-people-receiving-haemodialysis-100621967","NCT07377500","Dialysate Cooling for the Preservation of Cognitive Function in People Receiving Haemodialysis","Randomised Controlled Trial of Dialysate Cooling for the Preservation of Cognitive Function in People Receiving Haemodialysis","COOL HD","Inclusion Criteria:\n\n* The participant is receiving maintenance in-centre haemodialysis\n* Over 18 years of age at time of consent\n* The participant is able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Participants with confirmed diagnosis of dementia.\n* Participants who lack capacity to consent.\n* Participants having dialysis less than three times a week.\n* Pregnant participants.",{"count":98,"type":21},356,[63],"When a person's kidneys are not working properly, they need a life-saving treatment called haemodialysis three times a week to filter the waste and extra fluids from the blood. 25 000 adults in the United Kingdom are currently having haemodialysis and unfortunately more than two-thirds of these people experience problems with thinking and memory, which may lead to dementia. These problems tend to worsen more rapidly than people who are not on haemodialysis. This decline in brain function can make it harder for people to do everyday tasks, increase their reliance on others, and lower their overall quality of life. It also raises the chances of needing hospital care and can shorten their lifespan.\n\nOne reason for this decline in thinking and memory could be the dialysis treatment itself. Research has shown that blood flow to the brain can drop during dialysis. If this happens regularly, it can harm the brain over time. Earlier studies found that cooling the dialysis fluid slightly (to 0.5°C below body temperature) helped people tolerate dialysis better and showed less brain damage on magnetic imaging brain scans (MRI) after a year, compared to those who had haemodialysis without cooling the dialysis fluid. However, the investigators still don't know if this brain protection translates into better thinking and memory for people on haemodialysis.\n\nThis study will see if cooling the dialysis fluid helps preserve thinking and memory function.\n\nThe investigators will invite participants at three hospitals with haemodialysis centres to take part. Those who agree will be randomly assigned to either standard dialysis or cooled dialysis. The investigators will assess participants' thinking and memory functions using special tests at the start of the study and again after a year. By comparing the results from both groups, the investigators hope to see if the cooled dialysis really helps protect brain.",[102,103],"Haemodialysis","Kidney Failure",[105,106,107,108],"DIALYSATE COOLING","KIDNEY FAILURE","HAEMODIALYSIS","COGNITIVE IMPAIRMENT","NOT_YET_RECRUITING","2026-01-30",{"date":112,"type":42},"2026-02-03",{"date":114,"type":21},"2026-04-01",{"date":116,"type":21},"2028-01-01",{"name":48,"class":49},1,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":128,"conditions":129,"keywords":133,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":118},"100608756","multimorbidity-and-cardiovascular-risk-factors-after-renal-transplant-100608756","NCT07205692","Multimorbidity and Cardiovascular Risk Factors After Renal Transplant","MCaRT","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Capable of giving informed consent\n* In receipt of a single organ renal transplant and being followed up by UHDB as the referring team.\n\nExclusion Criteria:\n\n• Graft failure before return to follow up",{"count":127,"type":21},30,"Who can participate? Any adults over the age of 18 who have received a kidney transplant at the research centre are eligible for recruitment within the first month after transplant What does the study involve? The study involves observing and gathering data to understand how the health of people who receive a kidney transplant changes over the first year.\n\nIn particular the investigators are interested in the risk factors for heart disease and stroke, and how these change over the first year of transplant. The investigators are also interested in multiple health conditions, and how these impact patients after transplant.\n\nThere are no interventions but there will be measurements of diagnoses, risk factors for heart disease and stroke, and assessments of physical fitness Blood pressure, BMI, routine blood tests as well as assessing muscle and fat changes, how fit patients are and what new health conditions they have.\n\nWhat are the possible benefits and risks of participating? There is no active treatment or intervention, so there are no risks of benefits compared to normal care.\n\nWhere is the study run from? University Hospitals of Derby and Burton NHS trust, at the Royal Derby hospital Renal Department.\n\nWhen is the study starting and how long is it expected to run for? The study is expected to start 1\u002F9\u002F2025 and run for 2 years. Who is funding the study? The only costs of the study are funding for the staff member running the study, who is funded by the NIHR as an academic research fellow Who is the main contact? Dr Samuel Strain, Samuel.strain@nottingham.ac.uk",[130,131,132],"Kidney Transplant","Cardiovascular (CV) Risk","Multimorbidity",[134,135,136,137],"multimorbidity","kidney transplant","renal transplant","cardiovascular risk","2025-09-25",{"date":140,"type":42},"2025-10-03",{"date":142,"type":42},"2025-09-05",{"date":144,"type":21},"2027-08-01",{"name":48,"class":49},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":154,"minAge":18,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":61,"phases":157,"briefSummary":158,"conditions":159,"keywords":160,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},"100473807","biological-matrices-versus-synthetic-meshes-100473807","NCT05449691","Biological Matrices Versus Synthetic Meshes","BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices With Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction","BIOSYM","Inclusion Criteria:\n\nFemale age ≥ 18 Women undergoing mastectomy and immediate one-stage mesh assisted implant breast reconstruction as standard treatment\n\nExclusion Criteria:\n\nRevision reconstruction surgery Delayed reconstruction surgery","FEMALE",{"count":156,"type":21},60,[63],"In this feasibility study, 60 women undergoing reconstruction will be randomly allocated to receive biological or synthetic mesh and followed for 6 months. The findings will tell us if patients and surgeons are comfortable with not being able to choose which mesh is used for the operation. In the larger surgical study, the investigators plan to measure patients' satisfaction with the reconstruction, patients' quality of life, complications from the operation and costs over 5 years.",[26],[161,162,163,164,71,165],"breast reconstruction","mesh","acellular dermal matrix","synthetic mesh","patient reported outcome","2025-09-03",{"date":168,"type":42},"2025-09-10",{"date":170,"type":42},"2023-11-02",{"date":172,"type":21},"2026-04-30",{"name":48,"class":49},5,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":182,"sex":17,"minAge":183,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":118},"100513488","sodium-accumulation-study-in-haemodialysis-brain-study-100513488","NCT05966116","Sodium Accumulation Study in Haemodialysis: Brain Study","SASH-B","Inclusion Criteria:\n\n* Age 50-75 years inclusive\n* Male and female patients with CKD stage 5 receiving chronic haemodialysis\n* Patient has been dialysis dependent for at least 3 months\n* Must be able to follow simple instruction in English (on safety ground for MRI scans) and be able to understand the nature and requirements of the study\n\nExclusion Criteria:\n\n* Active infection or malignancy\n* Amputee\n* Pregnancy\n* Contraindication to MRI scanning including claustrophobia, pacemaker, metallic implants etc\n* Unable or unwilling to provide informed consent\n* Medical conditions or overall physical frailty precludes scan session in opinion of investigator\n* Any condition which could interfere with the patient's ability to comply with the study",true,"50 Years","75 Years",{"count":186,"type":21},10,"The aim of the research study is to look at a new type of MRI scanning that can measure the amount of sodium in different parts of the body. Sodium (or 'salt') levels are very important in maintaining health, and high levels lead to high blood pressure. This is very important to patients with kidney disease, as the kidney is the main organ that regulates the amount of sodium in the body. It is possible to measure blood sodium levels, but this does not tell us how much sodium is present in other areas of the body. Previously, it has not been possible measure this. Sodium MRI (Na-MRI) is a new type of MRI scanning that can directly measure sodium in other parts of body such as skin, muscles, kidneys, and brain. The investigators believe that this will help to guide treatment in patients with kidney disease who are on haemodialysis, research studies are needed to prove the benefits.",[189],"Dialysis; Complications","2024-08-07",{"date":192,"type":42},"2024-08-09",{"date":194,"type":42},"2024-07-18",{"date":196,"type":21},"2025-02",{"name":48,"class":49},""]