[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"uterine-sarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:uterine-sarcoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,79,108,133],{"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":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100628909","phase-2-ph-2-elacestrant-in-er-positive-uterine-sarcomas-100628909",false,"NCT07467772","Ph 2 Elacestrant in ER Positive Uterine Sarcomas","A Phase 2 Study Evaluating the Efficacy of Elacestrant in Patients With Estrogen Receptor Positive Uterine Sarcomas","Inclusion Criteria:\n\nParticipant must have histologically confirmed uterine sarcoma of one of the following subtypes: uterine leiomyosarcoma (uLMS), endometrial stromal sarcoma (ESS), uterine adenosarcoma, or uterine PEComa.\n\nTumor must have moderate to strong immunohistochemical expression in ≥75% of tumor cells of estrogen receptor (ER) as assessed by institutional pathology review.\n\nParticipants must have locally advanced or metastatic disease that is not amenable to surgery.\n\nParticipants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.\n\nAge ≥18 years at the time of consent\n\nECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).\n\nParticipants must have adequate organ and marrow function as defined below:\n\nHemoglobin ≥ 8.0 g\u002FdL\n\nabsolute neutrophil count ≥1,000\u002FmcL\n\nplatelets ≥100,000\u002FmcL\n\ntotal bilirubin ≤1.5 × institutional upper limit of normal (ULN)\n\nAST(SGOT)\u002FALT(SGPT) ≤3.0 × institutional ULN (unless liver metastases are present in which case it must be ≤ 5 × ULN)\n\nglomerular filtration rate (GFR) ≥60 mL\u002Fmin\u002F1.73 m2\n\nHuman immunodeficiency virus (HIV)-infected participants on effective non-CYP3A4 interacting (see Section 3.2.3) anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n\nFor participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n\nParticipants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\nParticipants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n\nParticipants must be disease-free of prior invasive malignancies for \\> 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. NOTE: If there is a history of prior malignancy, participants must not be receiving other specific treatment for that cancer.\n\nParticipants should have completed prior treatment for their cancer: chemotherapy or radiotherapy must have been completed for greater than 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.\n\nParticipants should have recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n\nParticipants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n\nParticipants must have a QTc interval length of below 450 msec. QTc will be calculated via the Fridericia's formula.\n\nParticipant must be willing to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n\nParticipant must be able to swallow and maintain pills.\n\nAbility to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) and\u002For family member available will also be eligible.\n\nWomen of childbearing age, women who are made postmenopausal through use of GNRH agonists must agree to use adequate contraception for the duration of protocol treatment and for at least 6 months after the last dose of elacestrant if the risk of conception exists.\n\nAdequate contraception is defined as one highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and\u002For partner.\n\nHighly Effective Non-Hormonal Contraception\n\nMethods of birth control which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly are considered highly effective forms of contraception.\n\nThe following non-hormonal methods of contraception are acceptable:\n\n* True abstinence when this is in line with the preferred and usual lifestyle of the participant. \\[Periodic abstinence (e.g., calendar, ovulation, symptothermal post-ovulation methods) and withdrawal are not acceptable methods of contraception\\].\n* Male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female participants, the vasectomized male partner should be the sole partner.\n\nOR Effective Non-Hormonal Contraception\n\nAlternatively, two of the following effective forms of contraception may be used instead:\n\nPlacement of non-hormonal intrauterine device (IUD) or intrauterine system (IUS). Consideration should be given to the type of device being15used, as there is higher failure rates quoted for certain types, e.g., steel or copper wire.\n\n* Condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository.\n* Occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository.\n* The use of barrier contraceptives should always be supplemented with the use of spermicide. Failure rates indicate that, when used alone, the diaphragm and condom are not highly effective forms of contraception. Therefore, the use of additional spermicides does confer additional theoretical contraceptive protection. However, spermicides alone are ineffective at preventing pregnancy when the whole ejaculate is spilled. Therefore, spermicides are not a barrier method of contraception and should not be used alone.\n\nIt should be noted that two forms of effective contraception are required. A double barrier method is acceptable, which is defined as condom and occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository.\n\nPremenopausal women must have a negative serum or urine pregnancy test. Pregnancy testing does not need to be pursued in female participants who are:\n\n* Age \\> 60 years; or\n* Age \\\u003C 60 with intact uterus and amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; or\n* Documented Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation\n\nWomen must be postmenopausal, which is defined as any of the following:\n\n* Age ≥ 60 years\n* Age \\\u003C 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH, and estradiol in the postmenopausal range per local normal range\n* Premenopausal women must be on GnRH agonist prior to study entry are eligible. Women in this group MUST remain on the GnRH agonist for the duration of protocol treatment.\n* Status-post bilateral oophorectomy - After adequate healing post-surgery\n\nExclusion Criteria:\n\nParticipants who are receiving any other investigational agents.\n\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to elacestrant.\n\nRapidly progressive, symptomatic, visceral spread of disease placing participant at risk of\n\nlife- threatening complications in the short term.\n\nParticipants with uncontrolled intercurrent illness, including but not limited to active infection, uncontrolled diabetes, cardiac disease, hypertension or conditions that in the opinion of the investigator would compromise participant safety or study participation\n\nParticipants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\nTreatment with strong CYP3A inducers\u002Finhibitors within 2 weeks before first study treatment administration or five elimination half-lives, whichever is longest and cannot be replaced. See Appendix B for a list of medications that are CYP3A inducers\u002Finhibitors.\n\nFemale participants who are pregnant or nursing.",true,"FEMALE","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is to evaluate the efficacy and safety of elacestrant, in participants with advanced estrogen receptor (ER)-positive uterine sarcomas. The name of the study drug involved in this research study is:\n\n-Elacestrant (a type of selective estrogen receptor degrader)",[27,28,29,30,31,32,33,34,35],"Uterine Sarcoma","Uterine Leiomyosarcoma","Endometrial Stromal Sarcoma","ESS","Perivascular Epithelioid Cell Tumors","Uterine Adenosarcoma","Uterine PEComa","Estrogen Receptor Positive Tumor","uLMS","RECRUITING","2026-05-21",{"date":39,"type":40},"2026-05-22","ACTUAL",{"date":42,"type":40},"2026-03-25",{"date":44,"type":21},"2028-04",{"name":46,"class":47},"Dana-Farber Cancer Institute","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":55,"targetDuration":57,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":66,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100613664","a-prospective-validation-study-of-radiomics-in-the-differential-diagnosis-of-uterine-leiomyoma-and-uterine-sarcoma-100613664","NCT07269535","A Prospective Validation Study of Radiomics in the Differential Diagnosis of Uterine Leiomyoma and Uterine Sarcoma","1. Inclusion Criteria:\n\n   1.1 Patients clinically evaluated and radiologically examined (including MRI, particularly T2WI and DWI sequences) who are diagnosed with uterine leiomyoma or considered highly suspected of uterine sarcoma, in combination with preliminary pathological findings.\n\n   1.2 Patients scheduled for surgical treatment or those eligible for long-term standardized follow-up.\n\n   1.3 Patients who are able to understand the study procedures and voluntarily sign the written informed consent form.\n2. Exclusion Criteria:\n\n2.1 Patients with severe organic diseases or a previous confirmed diagnosis of other malignant uterine tumors.\n\n2.2 Patients unable to complete baseline examinations, unable to comply with long-term follow-up, or unwilling to provide written informed consent.",{"count":56,"type":21},500,"5 Years","OBSERVATIONAL","In our previous study, based on the multi-center clinical big data collected from January 2012 to January 2025, we have completed the construction of a multimodal early warning model for the malignant transformation of uterine fibroids. The model was mainly based on T2WI and DWI sequences, and was trained and optimized by support vector machine (SVM) algorithm. In the retrospective study and internal validation, the model shows high sensitivity and specificity, which preliminarily proves that it has good application potential in identifying high-risk groups and predicting the risk of malignant transformation of uterine fibroids.\n\nHowever, there are still some limitations in retrospective studies and internal validation results, and its application value, universality and stability in real clinical environment have not been fully verified. Therefore, we plan to conduct a prospective validation study in consecutive patients enrolled after January 2025 to evaluate the clinical performance and generalization of the model in predicting the malignant tendency or risk of malignant transformation of uterine fibroids through practical application in the real population, and further analyze the operability in the actual diagnosis and treatment process and the potential value for patient management. This study will provide reliable evidence for early screening, follow-up management and individualized treatment of high-risk population, and has important clinical and public health significance for improving the early diagnosis rate, reducing the risk of malignant transformation and improving the prognosis of patients with uterine fibroids.",[61,27,62,63,64,65],"Uterine Fibroid","AI (Artificial Intelligence)","Radiomic","Prospective Observational Study","MRI",[67,61,68,62,63,65],"prospective observational study","uterine sarcoma","NOT_YET_RECRUITING","2025-11-26",{"date":72,"type":40},"2025-12-08",{"date":74,"type":21},"2025-11-30",{"date":76,"type":21},"2050-01-01",{"name":78,"class":47},"Tongji Hospital",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":88,"conditions":89,"keywords":95,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100613529","contribution-of-oncovascular-surgery-in-the-treatment-of-gynecological-advanced-malignant-diseases-100613529","NCT07267780","Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases.","The Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases: a Prospective and Retrospective Multicenter Study","Inclusion Criteria:\n\n\\- Retrospective Arm:\n\n1. Diagnosis of advanced or recurrent gynecologic cancer with vascular involvement requiring resection and\u002For reconstruction of major blood vessels, including:\n\n   * Ovarian carcinoma\n   * Cervical carcinoma\n   * Endometrial carcinoma\n   * Vulvar carcinoma\n   * Uterine or other types of sarcomas with vascular involvement\n2. Documented major vascular invasion, confirmed by preoperative imaging or intraoperative description.\n3. Patients who underwent onco-vascular surgery for advanced or recurrent gynecologic cancers between January 1, 2017, and August 31, 2025.\n4. Data Protection Impact Assessment (DPIA) approved for the management of retrospective data. (Deceased or untraceable patients will also be included to avoid selection bias, in accordance with Article 110 bis, paragraph 4 of the Italian Privacy Code. A DPIA will be produced and published on the Sponsor's website before study initiation, and patients who explicitly objected before death will not be included.)\n\nProspective Arm:\n\n1. Age ≥18 years\n2. Patients eligible for onco-vascular surgery for advanced or recurrent gynecologic cancers with vascular involvement, including:\n\n   * Ovarian carcinoma\n   * Cervical carcinoma\n   * Endometrial carcinoma\n   * Vulvar carcinoma\n   * Uterine or other types of sarcomas\n3. Documented major vascular invasion, confirmed by preoperative imaging or intraoperative description.\n4. Signed informed consent.\n\nExclusion Criteria:\n\n1. Patients younger than 18 years of age\n2. Patients with early-stage gynecologic cancers not eligible for onco-vascular surgery\n3. Patients undergoing vascular resection due to accidental injury of blood vessels not directly related to tumor infiltration.\n4. Patients who have previously undergone vascular surgery for reasons unrelated to the study, to avoid data overlap.",{"count":87,"type":21},130,"Multicenter ambispective observational study (prospective\u002Fretrospective)",[90,91,92,93,27,94],"Ovarian Carcinoma","Cervical Carcinoma","Endometrial Carcinoma","Vulvar Carcinoma","Gynecologic Tumor",[96,97],"Advanced or recurrent gynecologic tumor","Vascular infiltration","2025-11-25",{"date":100,"type":40},"2025-12-05",{"date":102,"type":21},"2025-12",{"date":104,"type":21},"2035-12",{"name":106,"class":47},"National Cancer Institute, Naples",2,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":48},"100577955","construction-of-a-model-for-the-differential-diagnosis-of-sarcomamyoma-based-on-the-radiomics-features-single-center-observational-study-100577955","NCT06805019","Construction of a Model for the Differential Diagnosis of SArcoma\u002Fmyoma Based on the RAdiomics Features: Single-center Observational Study","SARA","Inclusion Criteria:\n\n* Histological diagnosis of uterine sarcoma or myoma\n* Patients with pre-operative CT performed for diagnostic suspicion no more than 30 days before surgery\n* Age between 18 and 80 years\n* Patients followed in the clinical care path in our center\n* Obtaining informed consent\n\nExclusion Criteria:\n\n* Low quality of CT images.\n* Patients affected by other active neoplasms or diagnosed less than 5 years before the diagnosis of uterine sarcoma or myoma.","80 Years",{"count":117,"type":21},176,"Uterine sarcomas are rare and aggressive tumors originating from the muscular wall of the uterus. They have a high risk of recurrence and death, regardless of the stage of the disease at diagnosis. The therapy is surgical and involves hysterectomy preferably via laparotomy in consideration of the high risk of neoplastic dissemination through the rupture and fragmentation of the neoplasm as occurs through removal by other surgical routes which involve core drilling of the mass (laparoscopic, vaginal , hysteroscopic).\n\nUterine myoma represents a very frequent benign pathology in women, with an incidence of approximately 70%-80%. Asymptomatic cases do not require treatment, while symptomatic cases can be treated through the administration of generally antiestrogenic drugs to block growth and symptoms. Only a small part is removed surgically.\n\nCurrently the diagnosis of uterine sarcoma is almost always defined in the post-operative setting with the definitive histological examination, due to the lack of typical sonographic and radiological characteristics of certainty capable of differentiating benign neoplastic forms (myoma) from malignant ones of the uterus (sarcoma).\n\nMagnetic resonance imaging is currently the most reliable imaging modality for characterizing such uterine masses. Unfortunately, although it offers useful information, it is not able to discriminate with good precision a benign uterine lesion from a malignant one.\n\nCT is a method widely used in the staging of oncological diseases and therefore also in sarcomas. It is usually prescribed when there is an ultrasound doubt of a sarcoma before proceeding with surgery.\n\nHowever, although it is important in the definition of secondaries, it has very low sensitivity (60%) and specificity in the differential diagnosis between sarcoma and myoma.\n\nRadiomics is a novel approach that translates medical images into data by extracting a large number of quantitative features describing tissue characteristics, shape and texture, combining quantitative data analysis with biological and clinical endpoint.\n\nCapturing information from imaging that goes beyond the different biomedical imaging formats themselves is the great promise of this growing field.\n\nThe application of radiomics analysis to CT with the aim of preoperatively discriminating between sarcoma (malignant) and myoma (benign) could be a valid support in the preoperative evaluation and therapeutic decision-making process in order to personalize the most appropriate therapeutic approach .",[27,120],"Uterine Myoma",[68,122,123],"uterine myoma","radiomic","2025-01-28",{"date":126,"type":40},"2025-02-03",{"date":128,"type":40},"2022-11-07",{"date":130,"type":21},"2025-06-30",{"name":132,"class":47},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":48},"100560819","understanding-the-rarest-gynecological-cancers-a-multi--omics-platform-for-improved-patients-management-100560819","NCT06582108","UNDERSTANDING the RAREST GYNECOLOGICAL CANCERS: a MULTI -OMICS PLATFORM for IMPROVED PATIENTS MANAGEMENT","ROAR","Inclusion Criteria:\n\n* \\>18 years old\n\nHistological diagnosis of:\n\nNon-epithelial ovarian tumors Uterine sarcomas Vulvar cancer\n\nExclusion Criteria:\n\n* Active HIV, HBV, or HCV infection Synchronous neoplasms Non-rare histologies of gynecological malignancies",{"count":141,"type":21},190,"Rare gynecological cancers including uterine sarcomas, vulvar and non-epithelial ovarian cancers, are under-studied diseases and the absence of standardized diagnostic and therapeutic approaches or tailored clinical guidelines led to low survival rates and\u002For poor quality of life outcomes.\n\nThe ROAR project aims at increasing the molecular understanding of these diseases in a multidisciplinary, interinstitutional setting including gynecologic oncologists, medical oncologists, phase I researchers, pathologists, molecular pathologist, research nurses, genetists, bioinformatics, psychologists and patients' advocacy groups.\n\nThe project will pursue this aim through the following activities:\n\n1. Harmonizing procedures and enabling safe and easy data sharing across all involved institutions; this will be achieved by reviewing the available clinical and molecular data (WP1), establishing an interinstitutional second-opinion board (WP2\u002FTask1), developing a dedicated electronic customized research form (WP2\u002FTask2) and deploying a genomics platform (WP2\u002FTask3).\n2. Performing comprehensive somatic and transcriptional profiling as well as immunological landscape assessments on high quality annotated samples stored in a biobank dedicated to rare gynecological cancers; this will require systematic and standardized clinical data and biological samples collection (WP3\u002FWP4), standardization of pre-analytical and sequencing procedures (WP5\u002F6). The board will tailor indications and modalities for genomics and liquid biopsy assessments based on clinical features.\n3. Evaluating the clinical impact of the board on rare gynecological cancers management and, through the evidence gathered, implementing diagnostic and therapeutic strategies; this will include analyzing the activities of the board (WP7\u002FTask 1.1), integrating -omics data in the board report (WP7\u002FTask 1.2), evaluating liquid biopsy role in identifying minimal residual disease post-surgery, disease monitoring over time, capability of capturing tumor heterogeneity at baseline and identifying hot spot actionable molecular alterations. Finally, the evidence gathered from the ROAR project, will allow update of clinical guidelines or provide new recommendations for each rare gynecological cancer included. The results of ROAR will also be disseminated through direct access to the integrated platform developed.",[27,144,145],"Vulvar Cancer","Non Epithelial Ovarian Cancers (NEOC)","2024-08-30",{"date":148,"type":40},"2024-09-03",{"date":150,"type":21},"2024-09-15",{"date":152,"type":21},"2026-12-31",{"name":154,"class":47},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"]