[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gynecological-cancers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gynecological-cancers":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,48,71,99,126,152,186],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100621064","emotional-assessment-and-tiered-individualized-psychological-support-of-the-artificial-intelligence-robot-100621064",false,"NCT07365761","Emotional Assessment and Tiered Individualized Psychological Support of the Artificial Intelligence Robot","Emotional Assessment and Tiered Individualized Psychological Support for Newly Diagnosed Postoperative Gynecologic Patients: Development and Testing of the E-MOTE Artificial Intelligence Robot","Stage 1 (For patients and nurse) \\*\\*\\*Patients\\*\\*\\*\n\nInclusion Criteria:\n\n* Aged 18 years or older.\n* Diagnosed with gynecologic cancer and undergoing surgery.\n* Willing to receive E-MOTE robot and wear a smart wearable device.\n* Willing to complete pre-test and post-test questionnaires.\n\nExclusion Criteria:\n\n* Unable to communicate clearly.\n* Unwilling or unable to participate in the study in its entirety.\n\n\\*\\*\\*Nurse\\*\\*\\*\n\nInclusion Criteria:\n\n* Aged 18 years or older.\n* As a clinical nurse and has cared for patients who received the E-MOTE robot\n\nExclusion Criteria:\n\n\\- Unwilling to participate in the qualitative interview.\n\nStage 2 (only for patients) \\*\\*\\*Intervention group\\*\\*\\*\n\nInclusion Criteria:\n\n* Aged 18 years or older.\n* Diagnosed with gynecologic cancer and scheduled to undergo surgery.\n* Willing to receiveE-MOTE robot and to wear a smart wearable device.\n* Willing to complete pre-test and post-test questionnaires.\n\nExclusion Criteria:\n\n* Unable to communicate clearly.\n* Unwilling or unable to participate in the study in its entirety.\n\n\\*\\*\\*Control group\\*\\*\\*\n\nInclusion Criteria:\n\n* Aged 18 years or older.\n* Diagnosed with gynecologic cancer and scheduled to undergo surgery.\n* Willing to complete pre-test and post-test questionnaires.\n\nExclusion Criteria:\n\n* Unable to communicate clearly.\n* Unwilling or unable to participate in the study in its entirety.",true,"ALL","18 Years",{"count":20,"type":21},130,"ESTIMATED","INTERVENTIONAL",[24],"NA","To develop the E-MOTE robot and evaluate its effectiveness in addressing psychological distress, physical symptom, stress index, and quality of life, as well as to explore its clinical applicability.",[27,28,29],"Emotional Assessment","Nursing","Gynecological Cancers",[31,32,33,34,28],"Artifical inteligence","Robot","Emotional assessment","Psychological support","RECRUITING","2026-01-19",{"date":38,"type":39},"2026-01-26","ACTUAL",{"date":41,"type":39},"2025-10-01",{"date":43,"type":21},"2026-07-31",{"name":45,"class":46},"National Taiwan University Hospital","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":47},"100591184","phase-1-study-to-assess-the-safety-and-effects-of-porphysome-nanoparticles-for-imaging-in-gynaecological-cancers-100591184","NCT06977126","Study to Assess the Safety and Effects of Porphysome Nanoparticles for Imaging in Gynaecological Cancers","First-in Human Clinical Trial Assessing Porphysome Nanoparticles for Biodistribution and Safety, in Imaging of Advanced Metastatic Gynaecological Cancers","Inclusion Criteria:\n\n* Female patients age ≥ 18 years.\n* Life expectancy of \\>3 months.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n* Histologically confirmed metastatic advanced gynecological cancer. All epithelial subtypes are permitted. Patients receiving standard of care oncological treatment (i.e. chemotherapy and\u002For radiation) will be included.\n* Patient is able to understand and is willing to sign a written informed consent document prior to registration\u002Fenrollment on to study.\n* Patient is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n* Patients of childbearing potential (as assessed by their local Investigator) and their partners who are sexually active must agree to the use of 2 highly effective forms of contraception throughout the period of study treatment and for 12 months after last dose of study drug.\n* Baseline corrected QT (QTc) interval prolongation \\\u003C 470 milliseconds.\n* Within 8 days of the proposed enrollment patients must have adequate organ function.\n\nExclusion Criteria:\n\n* Patient is a candidate for therapy with curative intent.\n* Patient has a contraindication to PET\u002FCT imaging, including, but not limited to, phobias associated with imaging (e.g. claustrophobia) and those who cannot lie still in the supine position for at least 20 minutes.\n* Patients receiving nuclear medicine scans with other radiopharmaceutical agents (ex: 18F-FDG or other) during the study's exclusionary period will be excluded from the study.\n* Patients with known myelodysplastic syndrome\u002Facute myeloid leukemia.\n* Treatment with an investigational drug within 15 days prior to study registration.\n* Patients must not receive any other oncological treatments, including chemotherapy and\u002For radiation, within 2 weeks before starting study drug administration (and for 28 days after study drug administration).\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.\n* Patients with a known active COVID-19 infection at the time of registration\u002Fenrollment.\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the subject inappropriate for entry into this study.\n* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant or breast-feeding women.\n* Unresolved toxicity \\> CTCAE grade 1 from previous anti-cancer therapies, including radiotherapy, with exception.\n* Retinopathy ≥ grade 2.\n* Patients with porphyria.\n* Patients that have undergone a splenectomy.","FEMALE",{"count":57,"type":21},24,[59],"PHASE1","This is an open-label, first-in-human, dose escalation study evaluating investigational drug PORPHYSOSMES (PS, pegylated porphyrin-lipid conjugate-containing nanoparticle suspension) and 64Cu-PORPHYSOMES (64Cu-PS, pegylated Copper-64 labelled porphyrin-lipid conjugate-containing nanoparticle suspension) for PET\u002FCT imaging assessments in patients with metastatic\u002Fadvanced gynecological tumors.",[29],"2026-01-05",{"date":64,"type":39},"2026-01-08",{"date":66,"type":39},"2025-11-18",{"date":68,"type":21},"2027-11-19",{"name":70,"class":46},"University Health Network, Toronto",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":47},"100594241","anxiety-physiological-parameters-patient-satisfaction-and-vr-in-gynecological-oncology-surgery-100594241","NCT07016880","Anxiety, Physiological Parameters, Patient Satisfaction and VR in Gynecological Oncology Surgery","The Effect of Virtual Reality Intervention on Preoperative Anxiety, Physiological Parameters and Patient Satisfaction in Women Scheduled for Gynecological Oncology Surgery: A Randomised Controlled Trial","Inclusion Criteria:\n\n* The participant must have a confirmed diagnosis of gynecological cancer.\n* The participant must be aware of their gynecological cancer diagnosis.\n* Participants must be 18 years of age or older.\n* Verbal and written informed consent to participate in the study must be obtained.\n* The participant must be able to communicate verbally and in writing in Turkish.\n* No communication impairments (e.g., visual, auditory, or cognitive) should be present.\n* This must be the participant's first surgical intervention related to gynecological oncology.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status must not exceed 2.\n* The planned surgical procedure must be a laparotomy.\n\nExclusion Criteria:\n\n* History of recurrent gynecological cancer.\n* Presence of vision problems that prevent the use of VR goggles, including participants who wear glasses or have uncorrected vision impairment.\n* Presence of conditions such as migraines, vertigo, active nausea, vomiting, or frequent headaches.\n* Sensitivity to motion sickness.\n* Diagnosis of a psychiatric condition, whether under pharmacological or non-pharmacological treatment.\n* Withdrawal of consent during the study.\n* Removal of the virtual reality headset during the intervention.\n* Development of any medical complications during the intervention period.",{"count":79,"type":21},66,[24],"Surgical procedures often cause significant anxiety in patients, particularly among women undergoing gynecological oncology surgeries. Preoperative anxiety is a common and preventable condition that can negatively affect both physiological parameters and the overall surgical experience. It may lead to increased heart rate, elevated blood pressure, respiratory distress, and psychological discomfort, increasing the risk of complications during and after surgery. Women facing gynecological cancer surgery often experience heightened anxiety due to concerns about survival, loss of reproductive organs, body image changes, and sexual health.\n\nVirtual reality (VR) has emerged as a promising non-pharmacological approach for reducing preoperative anxiety. By immersing patients in a calming virtual environment that engages visual and auditory senses, VR helps promote relaxation, reduce stress, and enhance the patient's sense of control before surgery. It is safe, easy to implement, cost-effective, and does not have the side effects associated with medications.\n\nAlthough VR has demonstrated effectiveness in reducing anxiety in various surgical contexts-including orthopedic, colorectal, and minor gynecological procedures-its impact in gynecologic oncology surgery remains underexplored. This randomized controlled trial aims to evaluate the effect of a VR intervention on preoperative anxiety, physiological parameters (blood pressure, heart rate, respiratory rate, oxygen saturation), and patient satisfaction in women scheduled for gynecologic oncology surgery.\n\nParticipants will be randomly assigned to either the intervention group (receiving VR) or the control group (receiving standard care). Anxiety and physiological measures will be evaluated before and after the respective intervention in both groups. Patient satisfaction will be assessed once, immediately after the intervention and before surgery.\n\nThe primary objective is to assess whether VR effectively reduces preoperative anxiety and stabilizes physiological indicators. The secondary objective is to evaluate patient satisfaction with the preoperative experience. This study will contribute to the evidence base for using VR as a nursing-led, non-invasive strategy to enhance surgical care in gynecologic oncology.",[83,84,29,85],"Preoperative Anxiety","Women's Health","Gynecological Surgery",[85,87,83,88,89],"Gynecological Oncology","Preoperative Anxiety Management","Virtual Reality","2025-09-09",{"date":92,"type":39},"2025-09-10",{"date":94,"type":39},"2025-07-15",{"date":96,"type":21},"2026-07-15",{"name":98,"class":46},"Hacettepe University",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100603061","the-effect-of-cryocompression-on-peripheral-neuropathy-in-patients-receiving-chemotherapy-for-gynecological-cancer-100603061","NCT07131618","The Effect of Cryocompression on Peripheral Neuropathy in Patients Receiving Chemotherapy for Gynecological Cancer","CryoPN","Inclusion Criteria:\n\n* Applying to Mersin University Hospital Oncology Outpatient Clinic\n* Willing to participate and providing signed informed consent\n* Able to read and write in Turkish\n* Accessible and able to communicate\n* Citizen of the Republic of Türkiye\n* Diagnosed with gynecologic cancer (ovarian, endometrial, or cervical) and aged ≥18 years\n* Receiving weekly carboplatin + paclitaxel chemotherapy protocol\n* No subjective peripheral neuropathy symptoms before starting chemotherapy\n* No history of peripheral neuropathy related to previous taxane\u002Fplatinum-based chemotherapy protocols\n* No psychiatric disorders\n* No diseases that may cause peripheral neuropathy such as diabetes, rheumatoid arthritis, or fibromyalgia\n\nExclusion Criteria:\n\n* Not applying to the specified outpatient clinic\n* No gynecologic cancer diagnosis or younger than 18 years old\n* Not providing informed consent\n* Not receiving weekly carboplatin + paclitaxel chemotherapy protocol\n* Presence of subjective peripheral neuropathy symptoms before starting chemotherapy\n* History of peripheral neuropathy related to previous taxane\u002Fplatinum-based chemotherapy protocols\n* Presence of psychiatric disorders\n* Having diseases that may cause peripheral neuropathy such as diabetes, rheumatoid arthritis, or fibromyalgia",{"count":107,"type":21},78,[24],"Study Design:\n\nThis study is designed as a prospective, randomized controlled experimental study aiming to determine the effect of cryocompression therapy, applied during chemotherapy, on peripheral neuropathy symptoms in women with gynecologic cancers.\n\nResearch Hypotheses:\n\n* H₀: Cryocompression therapy has no effect on peripheral neuropathy.\n* H₁: Cryocompression therapy has an effect on peripheral neuropathy.\n\nStudy Population:\n\nThe study population will consist of women over the age of 18 living in Mersin, Türkiye, who are diagnosed with gynecologic cancer and undergoing chemotherapy between August 10 and December 31, 2025.",[29,111],"Peripheral Neuropathy Due to Chemotherapy",[113,114,115],"Gynecological cancer","cryocompression","peripheral neuropathy","NOT_YET_RECRUITING","2025-08-12",{"date":119,"type":39},"2025-08-20",{"date":121,"type":21},"2025-08-10",{"date":123,"type":21},"2025-12-31",{"name":125,"class":46},"Mersin University",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":4},"100600138","emergence-of-bacterial-resistance-to-antibiotics-in-the-digestive-microbiota-of-patients-treated-with-anticancer-drugs-100600138","NCT07093593","Emergence of Bacterial Resistance to Antibiotics in the Digestive Microbiota of Patients Treated With Anticancer Drugs","Emergence of Bacterial Resistance to Antibiotics in the Digestive Microbiota of Patients Treated With Anticancer Drugs (Clinical Component of the RAMA Project)","RAMA","Inclusion Criteria:\n\n* Men and women over 18\n* Chemotherapy-naive patients.\n* Patients due to start chemotherapy\u002Fradio chemotherapy who meet the criteria of the cohorts listed below :\n\n  1. Squamous cell carcinoma of the upper aerodigestive tract (Non-metastatic, locally advanced, operable or not; Patients receiving concomitant radiochemotherapy using a platinum salt (cisplatin, carboplatin))\n  2. Cervical and endometrial cancer (ocally advanced, Non-metastatic; Patients receiving concomitant radiochemotherapy using a platinum salt (cisplatin, carboplatin))\n  3. Gynecological cancer (advanced stage ; Patient to receive platinum salt + paclitaxel chemotherapy)\n  4. Mammary carcinoma (localised; Patient to receive adjuvant or neoadjuvant chemotherapy with epirubicin and cyclophosphamide without other associated treatment (targeted therapy \u002F immunotherapy))\n  5. Urothelial carcinoma (all stage ; Patient to receive neoadjuvant or adjuvant chemotherapy with platinum salt and gemcitabine)\n  6. Pancreatic adenocarcinoma (localised or metastatic ; Patients to be treated with gemcitamine alone or in combination with nab-paclitaxel)\n* OMS ≤ 2\n* Affiliation with a French social security scheme or beneficiary of such a scheme.\n* Signed informed consent indicating that the patient has understood the purpose and procedures of the study and agrees to participate in the study and to abide by the study requirements and restrictions\n\nExclusion Criteria:\n\n* Patients unable to collect \u002F send stools for medical, geographical, social or psychological reasons.\n* Patients who have already received chemotherapy\u002Fradiochemotherapy.\n* Use of anti-infectives for systemic use within 6 months prior to the first sampling, or any other concomitant disease\u002Fcondition that may influence stool analysis.\n* Pregnant women and nursing mothers.\n* Persons deprived of their liberty by judicial or administrative decision; persons under compulsory psychiatric care; persons admitted to a health or social institution for purposes other than research.\n* Adults subject to a legal protection measure - safeguard of justice, guardianship or curatorship - or unable to express their consent.",{"count":135,"type":21},260,[24],"Solid cancers are frequently treated with chemotherapies that target the DNA of cancer cells. It has recently come to light that bacteria are also the target of chemotherapies used in oncology. The results of current studies demonstrate the close link between the composition of the microbiota, the immune system, toxicity and the efficacy or otherwise of anti-cancer treatments.\n\nIn this context, the study will measure the influence of treatment with anticancer molecules known to activate the bacterial SOS response on the emergence of antibiotic-resistant commensal bacteria in the gut microbiota of cancer patients. Furthermore, this study will investigate the existence of a close link between changes in the intestinal microbiota determined by the induction or non-induction of the SOS response, bacterial translocation, the integrity of the intestinal barrier and the antitumor immune response.\n\nThe RAMA trial plans to collect stool and blood samples from two different cohorts of patients:\n\n* Unexposed cohort: patients receiving anti-cancer treatment that does not induce bacterial SOS response.\n* Exposed cohort: patients receiving anti-cancer treatment inducing the bacterial SOS response.\n\nPatients' stools will be collected within 7 days of their first chemotherapy treatment and within 7 days of the 3rd chemotherapy cycle. Two blood samples will be taken at the same time as the stool samples.\n\nThe results obtained from this prospective clinical research will then be investigated in two experimental laboratory models.\n\nThe aim is to demonstrate that cytotoxic anticancer drugs promote the emergence of antibiotic-resistant commensal bacteria, by means of this large-scale study comprising a clinical component, which is the subject of the research presented in this protocol, combined with laboratory research components.",[139,140,29,141,142],"Cervical Cancers","Endometrial Cancer","Pancreatic Adenocarcinoma","Upper Aerodigestive Tract Carcinoma","2025-07-22",{"date":145,"type":39},"2025-07-30",{"date":147,"type":21},"2025-09-01",{"date":149,"type":21},"2032-09-01",{"name":151,"class":46},"Centre Georges Francois Leclerc",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":163,"conditions":164,"keywords":169,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":182,"leadSponsor":184,"locationsCount":47},"100578807","gene-and-molecular-pathways-of-ozone-treatment-response-in-gynecological-tumor-patients-with-chronic-pelvic-pain-secondary-to-cancer-treatment-100578807","NCT06816095","Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Cancer Treatment","Gene and Molecular Pathway Characterization of the Response to Ozone Treatment in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Radio-chemotherapy","OzoGynEpigen","Inclusion Criteria:\n\n* Adult women (\\>=18 years old) with gynecological tumors treated with radiotherapy-chemotherapy.\n* Cancer disease is stable or in remission.\n* Life expectancy \\> = 6 months.\n* Patients included in the group of patients with pelvic pain must have a clinical, radiological, endoscopic, or histopathological diagnosis that their pain is not secondary to the oncological process.\n* Patients included in the group of patients with pelvic pain must have pain for \\>= 3 months duration, with an intensity \\>= 3 on the Visual Analog Scale (VAS), or classified as toxicity \\>= Grade-2 of the CTCAE v.5.0 of the National Cancer Institute of the USA.\n* Signed and dated informed consent specific to this study.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old.\n* Severe psychiatric disorders.\n* Inability to complete the quality of life questionnaires.\n* Active neoplasia requiring recent initiation (\\\u003C 3 months) of systemic or local treatment.\n* Life expectancy (for any reason) \\\u003C 6 months.\n* Failure to meet all inclusion criteria",{"count":161,"type":21},40,"OBSERVATIONAL","Gynecological cancers, including those affecting the ovaries, uterus, and cervix, represent a significant health burden for women. While survival rates have improved, many women experience chronic pelvic pain secondary to cancer treatment, especially radiotherapy and chemotherapy. This treatment-induced pelvic pain can be of difficult management and significantly affects patients' quality of life.\n\nIn our experience, ozone therapy has emerged as a promising complementary treatment for pain relief in patients with chronic diseases, including side effects of cancer treatment. However, the genetic and epigenetic mechanisms influencing its effectiveness have not yet been thoroughly studied.\n\nThe aim of this prospective study is to analyze how ozone therapy modulates the expression of certain genes and its impact on epigenetic clocks, which could help predict pain response.",[165,166,167,168,29],"Chronic Pelvic Pain Syndrome (CPPS)","Radiation-Induced Disorder","Radiotherapy Side Effects","Side Effect of Chemotherapy",[166,167,170,165,29,171,172,173,174,175,176,177],"Cancer survivors","gene expression","epigenetic clocks","side effects of cancer treatment","Toxicity of chemotherapy","Ozone therapy","Quality of Life","oxidative stress","2025-02-10",{"date":180,"type":39},"2025-02-12",{"date":178,"type":39},{"date":183,"type":21},"2027-08-14",{"name":185,"class":46},"Bernardino Clavo, MD, PhD",{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":198,"conditions":199,"keywords":200,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":210,"locationsCount":47},"100420866","phase-2-electrochemotherapy-of-gynecological-cancers-100420866","NCT04760327","Electrochemotherapy of Gynecological Cancers","GynECT","Inclusion Criteria:\n\n1. Local or regional relapse of gynecological tumors in which standard treatment options have been exhausted.\n2. Age more than 18.\n3. Life expectancy more than 3 month.\n4. Performance status Karnofsky ≥ 70 or WHO \\\u003C or 2.\n5. Treatment free interval minimum 2 weeks.\n6. Patient must be mentally capable of understanding the given information and regarding treatment and any adverse reactions that may occur during treatment.\n7. Patient must give informed consent.\n8. Patient must be discussed at the multidisciplinary team before entering the trial.\n9. Patient should be suitable for anesthesia.\n\nExclusion Criteria:\n\n1. Visceral, bone or diffuse metastases.\n2. Life-threatening infection and\u002For heart failure and\u002For liver failure and\u002For other severe systemic pathologies.\n3. Significant reduction in respiratory function.\n4. Age less than 18 years.\n5. Coagulation disturbances (those who do not respond on standard treatment with vitamin-K or fresh frozen plasma).\n6. Cumulative dose of ≥ 400 mg\u002Fm2 bleomycin received.\n7. Impaired kidney function (creatinin \\> 150 µmol\u002Fl).\n8. Patients with epilepsy.\n9. Pregnancy.\n10. Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.","105 Years",{"count":195,"type":21},30,[197],"PHASE2","To determine the effectiveness, feasibility and safety of electrochemotherapy in treatment of local and\u002For regional recurrences of gynecological cancers with electrochemotherapy in which standard treatment options have been exhausted.",[29],[201,202,203],"Electrochemotherapy","Cisplatin","Bleomycin","2024-10-16",{"date":206,"type":39},"2024-10-17",{"date":208,"type":39},"2020-07-01",{"date":123,"type":21},{"name":211,"class":46},"Institute of Oncology Ljubljana"]