[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adnexal-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adnexal-carcinoma":38},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,61,97],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":45,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":60},"100505262","phase-1-a-study-of-mq710-with-and-without-pembrolizumab-in-people-with-solid-tumor-cancer-100505262",false,"NCT05859074","A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer","A First-In-Human Phase I, Open Label, Safety and Tolerability Study of Escalating Multiple Doses of Intratumoral MQ710, a Multi-Transgene Expressing Modified Vaccinia Virus Ankara-Based Virotherapy, Alone and in Combination With the Systemic Checkpoint Inhibitor Pembrolizumab in Solid Tumors","Inclusion Criteria:\n\n* Age 18 or over\n* Histologically or cytologically documented advanced or metastatic cancer that has relapsed from or is refractory to standard treatment in two lines of prior therapy in the advanced setting unless there are fewer than two FDA approved lines of therapy for the particular disease, or for which no standard treatment is available\n* At least 2 tumors suitable for direct or ultrasound-guided injection defined as at least one cutaneous, subcutaneous, or nodal lesion or aggregate of lesions, ≥0.5 cm for any single lesion and cumulative lesion dimensions. One lesion must meet criteria for RECIST measurable disease if in Part 2. Note: One lesion will be biopsied (if possible)\n* Mandatory initial screening biopsy\n\n  a. For patients undergoing surgical excision\u002Fresection: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to biopsy and surgical procedure iii. Patient able to undergo surgical procedure and appropriate anesthesia b. For patients not undergoing surgical excision\u002Fresection to obtain mandatory screening biopsy: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to initial tumor biopsy\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Patients with no curative treatment options available including surgery and\u002For definitive radiation or patients in which these modalities are associated with significant morbidity\n* Patients with advanced disease who have received and progressed on standard therapy or have disease for which there is no standard therapy or have contraindications to standard therapy\n\nPart 1a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. Any malignancy with superficial cutaneous or subcutaneous lesions or palpable lymph nodes may be eligible based on the discretion of the investigator.\n\n* Part 2a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. BCC will also be included, given that pembrolizumab has not been approved for this condition, although cemiplimab is approved.\n* Parts 1b and 2b: Patients must have cSCC, Merkel cell carcinoma, melanoma, or head and neck squamous cell carcinoma. These patients should be refractory to anti-PD-1 therapy, with the exception of patients with HNSCC with PD-L1 expression \\\u003C1.\n* Parts 1a, 2a and 2b: Patients with BRAF-mutated melanoma should have received BRAF-targeted therapy.\n* Predicted life expectancy of 3 months or more (in both Part 1 and Part 2)\n* Participant or their legally authorized representative (LAR able to provide written informed consent to participate\n* Ability to comply with study procedures in the Investigator's opinion\n* Adequate renal function as defined by Cr \\\u003C2 mg\u002FdL\n* Adequate hepatic function\n\n  1. Serum bilirubin ≤1.5 x ULN\n  2. AST and ALT ≤2.5 ULN (no liver mets)\n  3. AST and ALT ≤5.0 ULN (for patients with liver mets)\n* Adequate bone marrow and hematologic function\n\n  1. Coagulation function adequate (PT and aPTT within x1.5 ULN)\n  2. Platelets ≥ 75,000\u002Fmm\\^2\n  3. ANC ≥ 1000\u002FuL\n* Females of child-bearing potential must have a negative pregnancy test within 14 days prior to enrollment and on day of treatment. All patients must agree to use adequate contraception prior to study entry, for the duration of study participation, and up to 90 days after the last dose of MQ710\n* Part 2 only: at least one measurable site of disease according to RECIST criteria\n* Prior non-immunotherapy, anti-tumor treatment including endocrine, chemical\u002Fradiotherapy, targeted therapy, or major surgery (but not anti-PD1\u002F- L1 therapies) was discontinued for more than 4 weeks prior to enrollment\n* Patients who have failed prior anti-PD1\u002F-PDL1 may be included. Washout of anti-PD1\u002F-PDL1 at least 3 weeks prior to initiation of therapy in Part 1a and 2a. No washout period is required for Part 1b and 2b.\n\nExclusion Criteria:\n\n* Splenectomy\n* Active infections requiring antibiotics, physician monitoring or recurrent fevers (\\>38.0 ℃) associated with a clinical diagnosis of active infection\n* Acute or chronic active viral disease or positive test for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV) with CD4 count \\\u003C100mg\u002Fm3, or received treatment with antivirals or nucleoside analogs such as those used in the treatment of hepatitis B (e.g. lamivudine, adefovir, tenofovir, telbivudine, entecavir), ribavirin, cidofovir, diaminopurine analogs, methyladenosine analogs, or interferon alpha within 4 weeks of initiation of study treatment .a. Patients with HIV are allowed on study if CD4 count is \\>100 cells\u002Fmm3.\n* Incomplete recovery from surgery, incomplete healing of an incision site\n* Any of the following in the 3 months before the first dose of study treatment: Grade 3 or 4 gastrointestinal bleeding\u002Fhaemorrhage (unless due to resected tumour), treatment-resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thrombo-embolic event, history or evidence of haemoptysis or menorrhagia\n* History of myocardial infarction, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classsification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia,or significant cardiovascular or cerebrovascular event in the 6 months before the first dose of study treatment\n* Uncontrolled infection within 6 months prior to study entry.\n* History of significant bleeding requiring hospitalization in the 12 months before the first dose of study treatment\n* Treatment with PD-1\u002Fprogrammed death ligand (PD-L1), cytotoxic T-lymphocyte associated protein 4 (CTLA-4), or any other (including experimental) immune checkpoint inhibitor or immune-stimulatory treatment in the 3 weeks before the first dose of study treatment\n* Prior chemotherapy, radiotherapy, biological cancer therapy (not including anti-PD1\u002F-L1 immunotherapies), targeted therapy, investigational drug, or major surgery 28 days prior to enrollment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment with the exception of grade 2 or better for alopecia and neuropathy.\n* Has known active CNS metastases and\u002For carcinomatous meningitis\n* Received live vaccine within 28 days prior to enrollment\n* Patient is pregnant or breast-feeding, or expecting to conceive or father children within the duration of the trial\n* Patients with tumor that directly contacts, encases or penetrates a major blood vessel, pericardium, gastrointestinal tract, or other hollow organs that may lead to perforation due to tumor necrosis\n* Patients at risk of airway compromise in the event of post-injection tumor swelling\u002Finflammation based on investigator judgement\n* History or evidence of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)\n* History of chronic liver disease or evidence of hepatic cirrhosis\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia, active interstitial lung disease (ILD) requiring treatment with systemic steroids\n* Baseline pulse oximetry less than 92% on room air\n* History of re-irradiation to a field which includes the carotid arteries\n* History of leukemia: ALL and CLL (patients with a history of aggressive lymphomas in remission or patients with a history of allogeneic stem cell transplants are eligible if no longer on immunosuppressive therapy and without evidence of GvHD)\n* Current use of steroids such as prednisone 10 mg\u002Fdaily or greater (or its equivalent) or immunosupressants within 2 weeks of initiation of study treatment\n* Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results\n* Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent\n* Known allergy to MQ710 transgene products or formulation.\n* Patient requires anticoagulation therapy, such as warfarin.","ALL","18 Years",{"count":19,"type":20},56,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Participants of this study will have a diagnosis of a solid tumor cancer that has come back to its original location or spread beyond its original location (advanced), came back (relapsed) or worsened (refractory) after standard treatments, or no standard treatments are available for the participants' cancer. The purpose of this study if to find the highest dose of MQ710 that causes few or mild side effects in participants with a solid tumor cancer diagnosis.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Cutaneous Squamous Cell Carcinoma","SCC - Squamous Cell Carcinoma","Basal Cell Carcinoma","BCC","BCC - Basal Cell Carcinoma","Melanoma","Merkel Cell Carcinoma","Sebaceous Carcinoma","Extramammary Paget Disease","Kaposi Sarcoma","Head and Neck Squamous Cell Carcinoma","HNSCC","Adnexal Carcinoma","Angiosarcoma","Cutaneous Neoplasm","Advanced Cancer","Metastatic Cancer","Refractory Cancer","Solid Tumor",[26,27,28,29,31,32,33,34,35,36,37,38,39,40,41,42,43,46,47,48,44],"MQ710","Memorial Sloan Kettering Cancer Center","22-278","RECRUITING","2025-12-02",{"date":52,"type":53},"2025-12-03","ACTUAL",{"date":55,"type":53},"2023-05-04",{"date":57,"type":20},"2028-05-04",{"name":47,"class":59},"OTHER",7,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":69,"minAge":17,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":75,"conditions":76,"keywords":83,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100565162","mirrors-frozen---comparing-open-vs-robotic-surgery-in-the-management-of-women-with-complex-pelvic-adnexal-masses--8cm-100565162","NCT06638593","MIRRORS-FROZEN - Comparing Open Vs Robotic Surgery in the Management of Women with Complex Pelvic Adnexal Masses ≤ 8cm.","MIRRORS-FROZEN - a Pilot Randomised Controlled Trial (RCT) Comparing Open Vs Robotic Surgery in the Management of Women with Complex Pelvic Adnexal Masses ≤ 8cm.","MIRRORS-FROZEN","Inclusion Criteria:\n\n* Complex adnexal Pelvic mass\u002Fes ≤8 cm with no malignant disease outside the adnexae on CT or MRI.\n* Women aged ≥18 \\& ≤100 years old.\n* Patients who had given their signed and written informed consent\n\nExclusion Criteria:\n\n* Adnexal pelvic mass \\> 8 cm.\n* Radiological or histological or cytological evidence of stage III or IV disease.\n* Lack of capacity to understand and give informed consent.\n* Patients not suitable for laparoscopic surgery, such as but not limited to those with severe aortic stenosis.\n* Any patient randomized to either of the study arms and found to have disease which appears greater than stage 1 will be withdrawn from the trial and treated according to the national guidelines","FEMALE","100 Years",{"count":72,"type":20},40,[74],"NA","Adnexal masses are growths that can form in the ovaries or fallopian tubes for different reasons, such as hormonal changes, infection, or cancer. These masses may cause pelvic discomfort, pain, constipation, or no symptoms at all. When adnexal masses are found on scans, they are described in a certain way to indicate if they could represent early-stage cancer, and the word \"complex\" is used to refer to these masses. Surgery is often recommended, where the mass is removed and examined under the microscope during surgery in a process called (frozen section analysis); to determine its true nature.\n\nIt is still difficult to confirm cancer before surgery, and many of these masses turn out to be benign (not cancerous) or borderline (slow-growing tumours). Currently, doctors use open surgery with a cut from at least the belly button to the pubic bone to remove these masses. Patients with a cancer diagnosis will then have more surgical steps including assessment and sampling of various areas inside the abdomen (known as staging surgery) to see how far the cancer has spread.\n\nRecovery after open surgery can be long and painful, with a slow return to normal daily activities. The trial investigators know from practice that robotic surgery has replaced open surgery for most benign adnexal diseases and other types of women's cancers, such as womb cancer. Recovery is quicker, with less pain and blood loss, allowing for a faster return to daily activities.\n\nThis study, MIRRORS-FROZEN (pilot), compares robotic versus the standard open surgery in managing women with complex adnexal masses of eight centimetres or less. The hope is to decrease the need for open surgery in patients with benign or borderline disease and to assess if robotic surgery has similar, worse, or better outcomes for patients with cancer.\n\nMIRRORS-FROZEN is funded by Intuitive Foundation and GRACE Charity. The investigators will establish the feasibility of conducting a large multicentre randomized controlled trial in the future comparing certain cancer outcomes between robotic and open surgery.",[77,78,79,80,38,81,82],"Ovarian Cancer","Ovarian Mass","Ovarian Cysts","Fallopian Tube Neoplasms","Adnexal Cyst","Adnexal Masses",[84,85,86],"Robotic","adnexal masses","Adnexal cysts","2024-10-10",{"date":89,"type":53},"2024-10-15",{"date":91,"type":53},"2024-09-23",{"date":93,"type":20},"2027-02-01",{"name":95,"class":59},"Royal Surrey County Hospital NHS Foundation Trust",1,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":69,"minAge":4,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":96},"100504004","improved-diagnosis-of-ovarian-cancer-100504004","NCT05842629","Improved Diagnosis of Ovarian Cancer","Patients with an adnexal mass observed at ultrasonography.",{"count":104,"type":20},1700,"OBSERVATIONAL","After implementation of systematic image description of adnexal masses, we aim to improve and evaluate our use of available imaging methods and biomarkers for classifying adnexal masses and distinguishing between benign and malignant adnexal masses in the hands of clinicians in Central Denmark Region.\n\nSecondarily, we want to improve our management of adnexal masses by evaluating the complications and longitudinal changes in conservatively managed adnexal masses.\n\nData is registered prospectively but analyzed retrospectively.",[108,77,79,109,110,38,111],"Ovarian Neoplasms","Adnexal Mass","Adnexal Lesion","Adnexal Neoplasm","2024-05-08",{"date":114,"type":53},"2024-05-09",{"date":116,"type":53},"2021-05-15",{"date":118,"type":20},"2028-12",{"name":120,"class":59},"University of Aarhus"]