[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Queensland Centre for Gynaecological Cancer\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":156},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,76,99,127],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100630700","early-study-evaluating-the-specificity-and-feasibility-of-the-early-biomarker-panel-for-ovarian-cancer-detection-100630700",false,"NCT07491081","EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection","Inclusion Criteria:\n\n1. Age between 50 and 74 years (inclusive).\n2. Postmenopausal status, defined as either:\n\n   2.1. At least 12 consecutive months of amenorrhoea following natural menopause or hysterectomy, or 2.2. At least 12 months of hormone replacement therapy (HRT) commenced for the management of menopausal symptoms.\n3. Signed written informed consent.\n\nExclusion Criteria:\n\n1. History of previous ovarian malignancy.\n2. History of bilateral oophorectomy.",true,"FEMALE","50 Years","74 Years",{"count":20,"type":21},1500,"ESTIMATED","INTERVENTIONAL",[24],"NA","The overall aim of the EARLY study is to systematically evaluate the impact of blood collection protocols, storage temperatures, transport conditions, and time to processing on the stability of extracellular vesicle (EV) biomarkers associated with ovarian cancer, with the potential to inform and improve future ovarian cancer screening practices.\n\nThis prospective study will inform future screening studies by:\n\n1. Assessing the feasibility of participant recruitment and blood sample collection for extracellular vesicle analysis in a real-world healthcare setting, including evaluation of the practicality and effectiveness of these processes.\n2. Evaluating the stability of collected and transported blood samples and isolated extracellular vesicles during shipment and storage.\n\nA total of 1,500 participants will be recruited through community groups across Queensland, Australia, in collaboration with the Mater Research Biobank. Eligible participants who provide informed consent will have approximately 30 mL of blood collected for extracellular vesicle analysis. Data will also be collected on demographics (e.g. age and ethnicity), lifestyle factors (e.g. smoking status), medical, surgical and gynaecological history, family history of cancer, date of last menstrual period, and use of hormone replacement therapy (HRT). Participation in the study will conclude after blood sample collection.",[27],"Ovarian Cancer",[29,27,30,31,32],"Ovarian Cancer Detection","Ovarian Cancer Screening","Ovarian Cancer Blood Test","Extracellular Vesicles","RECRUITING","2026-03-19",{"date":36,"type":37},"2026-03-24","ACTUAL",{"date":39,"type":37},"2026-02-01",{"date":41,"type":21},"2030-12-31",{"name":43,"class":44},"Queensland Centre for Gynaecological Cancer","OTHER_GOV",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100552711","phase-3-a-phase-iii-randomised-clinical-trial-of-ultrasound-groin-monitoring-versus-groin-lymph-node-dissection-to-de-escalate-the-extent-of-surgery-in-vulvar-cancer-100552711","NCT06476639","A Phase III Randomised Clinical Trial of Ultrasound Groin Monitoring Versus Groin Lymph Node Dissection to De-Escalate the Extent of Surgery in Vulvar Cancer","ANVU","Inclusion Criteria:\n\n* Females, over 18 years, with histologically confirmed SCC or adenocarcinoma of the vulva\n* Clinically stage 1b or 2 on medical imaging (CT or MRI scan of pelvis, abdomen, and chest), without evidence of regional or distant metastatic disease\n* Willing and able to undergo IFL\u002FSNB according to local clinical practice management guidelines\n* Willing and able to comply with all study requirements, timing and\u002For nature of required assessments.\n* Signed written informed consent\n* Negative (serum or urine) pregnancy (BHCG) test ≤ 30 days of surgery ONLY in pre-menopausal women and women \\\u003C 2 years after the onset of menopause.\n\nExclusion Criteria:\n\n* Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget's disease)\n* Clinical or medical imaging evidence of regional and\u002For distant metastatic disease\n* Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)\n* Other prior malignancies \\\u003C5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma in situ\n* Estimated life expectancy of ≤6 months","18 Years",{"count":55,"type":21},640,[57],"PHASE3","This study is a phase III, open label, multicentre, three-group, randomised clinical trial. The primary aim of this study is to determine whether intensive groin ultrasound monitoring (1) is effective and safe to replace invasive groin lymph node dissection (LND) to manage vulvar cancer, (2) decreases the morbidity associated with vulvar cancer surgery, and (3) is cost effective.",[60,61,62,63,64],"Vulvar Cancer Stage I","Vulvar Cancer Stage II","Lymph Node Metastasis","Groin Node","Ultrasound Therapy; Complications",[66,67],"Vulvar Cancer","Ultrasound Therapy","NOT_YET_RECRUITING",{"date":36,"type":37},{"date":71,"type":21},"2026-06-01",{"date":73,"type":21},"2035-12-31",{"name":43,"class":44},9,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":5},"100536387","node-groin-ultrasound-cancer-100536387","NCT06264167","NODE (groiN ultrasOunD cancEr)","Randomised Feasibility Study of Groin Ultrasound Surveillance to De-Escalate Surgical Intervention in Women With Vulvar Cancer","NODE","Inclusion Criteria:\n\n* Women, over 18 years, with histologically confirmed SCC or adenocarcinoma of the vulva\n* Clinically stage I or II on medical imaging (CT scan of pelvis, abdomen, and chest), without evidence of regional or distant metastatic disease\n* Participant must be suitable to undergo IFL\u002FSNB according to local clinical practice management guidelines\n* Signed written informed consent\n* Negative serum pregnancy test ≤ 30 days of surgery in pre-menopausal women and women \\\u003C 2 years after the onset of menopause\n* Patient lives within 40 km of a medical diagnostic imaging centre (site investigator approval required for special circumstances)\n\nExclusion Criteria:\n\n* Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget's disease)\n* Clinical or medical imaging evidence of regional and\u002For distant metastatic disease\n* Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)\n* Other prior malignancies \\\u003C5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma in situ\n* Estimated life expectancy of ≤6 months",{"count":85,"type":21},30,[24],"This study is an open label, prospective, experimental, randomised clinical trial. The primary aim of this study is to determine whether it is feasible to randomise vulvar cancer patients into one of two treatment arms:1) surgical groin node dissection (as delivered though either a sentinel node biopsy or inguinofemoral lymph node dissection (IFL), or 2) serial high-resolution bilateral groin ultrasound surveillance and clinical examination every 2 months for 12 months.",[89,61,62,63,64],"Vulvar Cancer Stage Ib",[66,67],"2026-02-18",{"date":93,"type":37},"2026-02-20",{"date":95,"type":37},"2024-07-01",{"date":97,"type":21},"2027-12-31",{"name":43,"class":44},{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100368161","phase-3-sentinel-node-biopsy-in-endometrial-cancer-100368161","NCT04073706","Sentinel Node Biopsy in Endometrial Cancer","A Phase III Randomised Clinical Trial Comparing Sentinel Node Biopsy With No Retroperitoneal Node Dissection in Apparent Early-Stage Endometrial Cancer","ENDO-3","Inclusion Criteria:\n\n1. Females, over 18 years, with histologically confirmed primary epithelial cancer of the endometrium of any cell type or uterine carcinosarcoma (mixed malignant mullerian tumour);\n2. Clinically stage I disease (disease confined to body of uterus);\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n4. Signed written informed consent;\n5. Participant must meet criteria for a laparoscopic or robotic surgical approach as determined by the treating physician (e.g. suitable for TH BSO, ability to tolerate Trendelenberg positioning)\n6. All available clinical evidence (physical examination findings, or medical imaging such as CT, MRI or ultrasound) demonstrates no evidence of extrauterine disease\n7. Myometrial Invasion on MRI of not more than 50%. (Only if participant is \\\u003C45yo, has ONLY Grade 1 EAC and wishes to retain their ovaries).\n8. Negative (serum or urine) pregnancy test ≤ 30 days of surgery in pre-menopausal women and women \\\u003C 2 years after the onset of menopause.\n\nExclusion Criteria:\n\n1. Evidence of extrauterine disease (apparent involvement of cervix, vagina, parametria, adnexa, lymph nodes, bladder, bowel or distant sites) by clinical examination and\u002For through medical imaging.\n2. Enlarged retroperitoneal pelvic and\u002For aortic lymph nodes (\\>1 cm) on medical imaging;\n3. Estimated life expectancy of less than 6 months;\n4. Patients who have absolute contraindications for adjuvant radiotherapy and\u002For chemotherapy;\n5. Patients who have previously received radiation treatment to the pelvis\n6. Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);\n7. Patient compliance and geographic proximity that do not allow adequate follow-up;\n8. Patients with allergy to Indocyanine Green (ICG)\n9. Patients who have had previous retroperitoneal surgery\n10. Patients who require a retroperitoneal (pelvic +\u002F- para-aortic) lymph node dissection (lymphadenectomy)\n11. Other prior malignancies \\\u003C5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma of the breast insitu\n12. Uterine perforation during endometrial tissue sampling",{"count":108,"type":21},760,[57],"Endometrial cancer (EC) is the most common gynaecological cancer. Current treatment of EC typically includes removal of the uterus and to determine the extent of the disease (removal of fallopian tubes, ovaries \\& if required a lymph node dissection (surgical staging)). While lymph node dissection may be valuable to guide the need for adjuvant treatment (chemo or radiotherapy) after surgery, it has been a topic of controversy for the last 30 years. In some patients it causes morbidity, specifically lymphoedema. This recently has been replaced with sentinel node biopsy (SNB). It requires an injection of a dye into the cervix with specific equipment \\& surgical dissection of the lymph node in which the dye first becomes visible. Despite this promising proposition \\& similar to a lymph node dissection, the value to patients, cost effectiveness \\& potential harms (e.g. lymphedema) of SNB compared to no-node dissection in EC has never been established. Aim: determine the value of SNB for patients, the healthcare system and exclude detriment to patients using a randomised approach 1:1. Stage 1 - 444 patients. Stage 2 additional 316 patients.\n\nPrimary Outcome Stage 1:\n\nProportion of participants returning to usual daily activities at 12 months from surgery using the EQ-5D which will determine when women in both groups can return to their usual activities.\n\nPrimary Outcome Stage 2:\n\nTreatment non-inferiority as evaluated by disease-free survival status at 4.5 years post-surgery, as measured by the time interval between the date of randomisation and date of first recurrence. Confirmation of recurrent disease will be ascertained through clinical assessment, radiological work-up and\u002For histological results.",[112,113,114],"Endometrial Cancer Stage I","Sentinel Lymph Node","Surgery",[116,117],"uterine cancer","sentinel node biopsy","2026-01-28",{"date":120,"type":37},"2026-01-30",{"date":122,"type":37},"2021-01-18",{"date":124,"type":21},"2031-02",{"name":43,"class":44},19,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":139,"conditions":140,"keywords":144,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},"100537517","phase-2-satellite-study-feasibility-safety-efficacy-dostarlimab-early-stage-deficient-endometrial-cancer-100537517","NCT06278857","SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)","A Phase 2b, Open-label, Single Arm, Multicentre, Pilot Study of the Efficacy, Safety and Tolerability of Dostarlimab in Women With Early-stage MMR Deficient Endometrioid Endometrial Adenocarcinoma.","SATELLITE","Inclusion Criteria:\n\n1. Female participant is at least 18 years of age (at the time of informed consent).\n2. Participant has:\n\n   i. histologically or cytologically proven Stage 1, FIGO grade 1 or 2, MMR deficient (Absence of at least one MMR protein (MLH1, PMS2, MSH2, MSH6) by immunohistochemistry.) endometrioid endometrial adenocarcinoma, and\n\n   ii. wish to preserve the uterus or are not a suitable candidate for hysterectomy.\n3. Participant has an ECOG performance status of ≤ 2\n4. Participant demonstrates no evidence of extrauterine disease assessed from all available clinical evidence (physical examination findings) and medical imaging including standard of care diagnostic CT, MRI, ultrasound, or X-ray and screening gadolinium contrast pelvic MRI\n5. Participants must have adequate organ and bone marrow function defined as:\n\n   i. absolute neutrophil count 1.5 x 109\u002FL ii. platelets 100 x 109\u002FL iii. haemoglobin ≥9 g\u002FdL\n\n   Adequate liver function:\n\n   iv. total bilirubin \\\u003C 1.5x institutional upper limit normal (ULN) v. AST\u002FALT \\\u003C 2. 5 - 3x ULN\n\n   Adequate renal function as defined by:\n\n   vi. Creatinine \\\u003C 1.5x institutional upper limits OR creatinine clearance \\> 30 ml\u002Fmin\n\n   Adequate coagulation profile:\n\n   vii. INR or PT ≤ 1.5 x ULN unless the participant is receiving anticoagulant therapy as long as INR or PTT is within the therapeutic range of intended use of anticoagulants viii. aPTT ≤ 1.5 x ULN unless the patient is receiving anticoagulant therapy as long as INR or PTT is within the therapeutic range of intended use of anticoagulant\n6. A potential participant with a clinical abnormality or laboratory parameters outside the normal reference range for the population being studied may be rescreened once, at the Investigator's discretion, and may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors to the participant and will not interfere with the study procedures.\n7. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at enrolment prior to each treatment cycle and use a highly effective contraceptive method including; oral contraceptive pills \\[OCPs\\], or an intrauterine hormone device \\[IUD\\]) from screening until at least 4 months following the last dose of dostarlimab. Females who are abstinent from heterosexual intercourse as part of their usual lifestyle do not need to use contraception.\n8. Post-menopausal females. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels (≥ 40 IU\u002FmL) at screening for amenorrhoeic (≥ 12 months) female participants.\n9. Participants with confirmed Type I or Type II diabetes mellitus must be well controlled by medication and\u002For diet and have glycated haemoglobin (HBAc1) \\\u003C 8.5% at screening and be willing to monitor blood glucose levels at home during study participation.\n10. Participants must have normal blood pressure (BP) or adequately treated and controlled hypertension.\n11. Participant is able to provide written informed consent and are willing to participate for the duration of the study and to follow study procedures.\n\nExclusion Criteria:\n\n1. Participant has a histological (cell) type other than endometrioid adenocarcinoma (sarcomas or high-risk endometrial e.g., papillary serous, clear cell).\n2. Participant is pregnant, breastfeeding, or planning to become pregnant during the trial period.\n3. Participant has had an allogeneic tissue\u002Fsolid organ transplant.\n4. Participants with uncontrolled hypertension, history of hypertension crisis, history of hypertensive encephalopathy, QTc\\>450 at baseline, other severe cardiovascular diseases including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction (MI), unstable angina, New York Heart Association (NYHA) class III and IV heart failure and uncontrolled arrhythmia within the past 6 months. Rate-controlled arrhythmia may be eligible at the discretion of the Investigator.\n5. Participant is considered a poor medical risk due to an uncontrolled medical disorder, non-malignant systemic disease, or active infection (including, r acute pelvic inflammatory disease), requiring intravenous antibiotics within the past 2 weeks. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent).\n6. Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days before the study start.\n7. Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Use of inhaled steroids, local injection of steroids, and steroid eye drops are allowed.\n8. Participant with severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2; COVID-19) influenza A\u002FB within 3 months of screening.\n9. Participant received a transfusion of blood products (including platelets or red blood cells) within 21 days prior to the first dose of the study drug.\n10. Participant has undergone major surgery in the 4 weeks prior to consent.\n11. Participant has -experienced any of the following with prior immunotherapy: any immune-related AE (irAE) of Grade 3 or higher, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome\u002Fmyasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms \\[DRESS\\] syndrome), or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary.)\n12. Participant has taken part in a clinical trial of an investigational medical product or device within 30 days or 5 half-lives before study start, whichever comes later. \\[except hormonal IUD\\]\n13. Participant has a concomitant malignancy, or participant has a prior non-endometrial invasive malignancy who has been disease-free for ≤5 years since end of treatment for the malignancy Non-melanoma skin cancer and definitively treated in-situ carcinomas is allowed.\n14. Participant has a known history of Human Immunodeficiency Virus (HIV), or a positive test at screening.\n15. Known active Hepatitis B or C, complete curative treatment and have no detectable viral RNA.\n16. Participants are known to be hypersensitive to the active substance or any of the excipients.\n17. Participant has a history or current diagnosis of interstitial lung disease.\n18. Participant has received or is scheduled to receive, a live vaccine within 30 days before the first dose of study treatment, during study treatment, and for up to 180 days after receiving the last dose of study treatment.\n19. Unwilling or unable to follow protocol requirements, including attendance at follow-up visit\u002Fs.\n20. Participant has any condition contraindicated with tumor \u002Fblood sampling procedures required by the protocol.",{"count":136,"type":21},10,[138],"PHASE2","The main goal of this clinical trial is to evaluate dostarlimab, an immunotherapy drug, as a potential alternative to surgery for early-stage endometrial cancer with Mismatch Repair deficiency, a genetic cause for 20-30% of cases. The study aims to establish dostarlimab's efficacy and safety in early-stage endometrial cancer, exploring its potential as a non surgical option for those unsuitable or unwilling to undergo major surgery, allowing for fertility preservation or addressing specific health conditions.\n\nParticipants will have seven dostarlimab sessions over 12 months. The treatment plan involves four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks.\n\nThis research is a promising step toward a new, less invasive treatment choice for patients with specific genetic traits. It expands the range of care options for endometrial cancer.",[112,141,142,143],"Mmr Deficiency","Endometrioid Endometrial Adenocarcinoma","Immune-related Adverse Event",[112,141,145,146],"Immunotherapy drug","Anti-programmed death receptor - 1(PD-1)","2024-12-02",{"date":149,"type":37},"2024-12-03",{"date":151,"type":37},"2024-08-01",{"date":153,"type":21},"2028-06-30",{"name":43,"class":44},3,""]