Endometrial Hyperplasia

Researchers are comparing two different surgical tools, a 5 Fr bipolar electrode and a 5 Fr angled conical optical fiber for a dual wavelength diode laser, to perform hysteroscopic polypectomy in an outpatient setting. The study aims to assess procedure time, use of additional instruments, procedure effectiveness and safety, sample quality for analysis, instrument suitability, patient pain and anxiety, and changes in quality of life after treatment for women with suspected small endometrial polyps. Participants will undergo a detailed medical evaluation and pelvic ultrasound before the procedure. During outpatient hysteroscopy without anesthesia, one of the two tools will be used for polypectomy. The procedure is performed using a vaginoscopic approach with saline distension and continuous video recording. The operator will evaluate the instrument's performance, and a pathologist will assess the tissue sample quality. Pain and anxiety will be measured 20 minutes after the procedure, and patients will be observed for 30 minutes before discharge. Follow-up occurs 60 days later with another pelvic ultrasound to check for residual tissue, repeated quality of life questionnaires, and assessment of any late complications. The study measures the time to complete the hysteroscopic procedure as the primary outcome while also tracking additional instrument use, lesion removal effectiveness, adverse events, tissue quantity, instrument suitability, pain, anxiety, and quality of life over time. Women aged 18 to 60 with small suspected single polyps and specific symptoms may participate.

This research aims to collect real-world data on the Cerene Cryotherapy Device, which is used to treat heavy menstrual bleeding in premenopausal women who have completed childbearing. The goal is to compare outcomes from everyday use with those reported in earlier clinical studies, better understanding its effectiveness, safety, and usage in routine care. The study is observational and involves women receiving treatment as part of their usual care. Women enrolled in this registry will have undergone Cerene treatment according to standard care practices. The study will include up to 300 women, with no additional interventions beyond their normal medical treatment. Data will be gathered through patient and physician surveys covering demographics, quality of life, procedure details, and clinical outcomes from before treatment through 12 months after. Participants will be involved for about 13 months from enrollment to one year post-treatment. Surveys will be completed at baseline and at specified times during follow-up. Researchers will assess outcomes such as the need for further interventions, treatment location, and quality of life changes. Physician feedback and cost analysis will also be collected to provide a comprehensive understanding of the device's use in real-world settings.

Researchers are evaluating DM002, a bispecific antibody-drug conjugate designed to target MUC1 and HER3, in people with advanced solid tumors such as ovarian, prostate, endometrial, colorectal cancers, and other solid carcinomas. The study is divided into two parts: Part 1 focuses on testing increasing doses to find the safest and most effective amount, while Part 2 uses the best dose from Part 1 to further assess safety and how the cancer responds. This Phase I, open-label trial aims to understand how the body processes DM002 and to monitor any side effects at different dose levels. Participants will receive DM002 as an intravenous infusion once every three weeks, with doses ranging from 1.0 mg/kg up to 7.5 mg/kg. Part 1 involves dose escalation across up to six or more groups to evaluate safety and tolerability. In Part 2, participants receive the selected optimal dose determined from Part 1. The treatment cycles last 21 days each, and dose adjustments may occur based on safety and pharmacokinetic data. DM002 is provided as a sterile lyophilized powder for infusion. Participants will attend at least 17 visits, starting with a screening phase lasting up to 28 days. Treatment cycles occur every 21 days, followed by an End of Treatment visit 21 days after the last dose and a Follow-up visit 30 days later. Telephone check-ins will continue every three months to monitor wellbeing and any new anticancer treatments started. Researchers will measure dose-limiting toxicities, maximum tolerated dose, drug levels in the blood, and cancer response using objective measures over 12 months.

Researchers are evaluating the safety, tolerability, and preliminary effectiveness of LY4170156, a drug targeting folate receptor alpha-expressing tumor cells, in participants with advanced solid tumors. The study focuses on several types of cancers including ovarian, endometrial, cervical, non-small cell lung, triple negative breast, pancreatic, and colorectal cancers. This research is a phase 1a/1b trial conducted by Eli Lilly and Company and will last up to about four years. The study consists of two parts: phase 1a, which involves dose escalation and optimization of LY4170156 alone or in combination with other drugs such as bevacizumab, carboplatin, itraconazole, and pembrolizumab, all given intravenously or orally as appropriate; and phase 1b, which is a dose-expansion phase to further assess the drug's effects. Participants may receive LY4170156 alone or with these additional treatments in various dosing schedules. During the trial, participants will undergo assessments to determine the recommended phase 2 dose, monitor antitumor activity, and track serious adverse events related to the drug over up to four years. Researchers will measure outcomes such as overall response rate, duration of response, time to response, progression-free survival, and disease control rate. Blood samples and pharmacokinetic studies will be conducted during the first 84 days to understand how the drug behaves in the body. Safety and tolerability will be closely monitored throughout the study.

Researchers are evaluating the safety and preliminary effectiveness of LY4175408, an antibody drug conjugate, in people with selected advanced solid tumors such as non-small cell lung cancer, small cell lung cancer, endometrial cancer, and triple negative breast cancer. This Phase 1a/1b trial also studies how LY4175408 moves through and is processed by the body. Participation in the study could last up to 4 years. Participants receive LY4175408 through intravenous (IV) infusion, with doses adjusted during an initial escalation phase. Some participants may also receive pembrolizumab alone or combined with chemotherapy drugs carboplatin or cisplatin, all given by IV. The study includes several groups, such as dose escalation, dose optimization, and dose expansion cohorts, with treatments tailored based on disease status and prior therapies. During the study, participants undergo regular assessments including monitoring for dose-limiting toxicities, tumor response evaluations, and pharmacokinetic blood tests to measure drug levels. Researchers will track outcomes like overall response rate, progression-free survival, and duration of response up to about 4 years. Safety and tolerability are closely observed throughout the trial to understand LY4175408's effects over time.

Researchers are evaluating the safety, tolerability, and effectiveness of LY4257496, a radioligand therapy targeting the Gastrin-releasing Peptide Receptor (GRPR), in adults with advanced GRPR-positive cancers such as breast, colorectal, prostate, endometrial, esophageal, gastroesophageal junction, and gastric cancers. This phase 1a/b, open-label study also assesses LY4257529, a diagnostic agent used to identify cancers with high GRPR levels. The study aims to determine appropriate dosing and response rates in this patient population. The study consists of two parts with various cohorts receiving LY4257496 intravenously, either alone or combined with standard anticancer therapies like Fulvestrant, Imlunestrant, Aromatase Inhibitors, Capecitabine, or Abemaciclib. LY4257529 is administered intravenously at selected sites for diagnostic purposes. Participants may receive dose escalation, dose optimization, or combination treatment depending on their specific cancer type and cohort assignment. Participants will undergo regular assessments including imaging scans such as CT or MRI to measure tumor response, laboratory monitoring, and safety evaluations throughout the study duration, which could last up to 36 weeks or until tumor progression. Researchers will monitor dose-limiting toxicities, maximum tolerated dose, drug concentration levels, and objective response rates. Follow-up will continue to evaluate treatment effects and safety after dosing periods.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of a novel oral drug called NKT3964 in adults with advanced or metastatic solid tumors. The study aims to find the recommended dose for further testing and to observe how the drug affects various types of advanced cancers, including ovarian, endometrial, gastric, lung, and breast cancers, particularly those with specific genetic markers like CCNE1 amplification. The study has two main phases: Dose Escalation and Dose Expansion. In the Dose Escalation phase, participants receive increasing doses of NKT3964 to assess safety, side effects, and appropriate dosing. The Dose Expansion phase uses the recommended dose from the first phase to further evaluate the drug’s anti-tumor activity in specific tumor types. Both phases involve oral administration of the study drug, with detailed criteria for patient eligibility based on cancer type, prior treatments, and genetic markers. Participants will undergo regular assessments including physical exams, laboratory tests, imaging scans, and tumor biopsies before and during treatment. Researchers will monitor drug levels in the blood, treatment side effects, and tumor responses using standard criteria over periods ranging from one month to two years. The study also tracks progression-free survival, overall survival, and other measures to understand the drug’s impact and safety profile. Participation involves ongoing monitoring and follow-up visits throughout the study duration.

Researchers are evaluating the effects of Dostarlimab alone or combined with Bevacizumab compared to standard nonplatinum chemotherapy in women with recurrent gynecological clear cell carcinoma, including cancers of the ovary, endometrium, cervix, vagina, and vulva. This phase II, randomized, open-label study aims to understand which treatment approach may better control disease progression and improve outcomes in this patient population. Participants will be divided into three groups: Group A receives Dostarlimab alone with an initial dosing of 500 mg every 3 weeks for 3 cycles, followed by 1000 mg every 6 weeks for up to 24 months. Group B receives the same Dostarlimab schedule plus Bevacizumab at 15 mg/kg every 3 weeks until disease progression or unacceptable side effects. Group C receives general chemotherapy with one of the drugs Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, or Gemcitabine. All treatments are given intravenously. During the study, participants will be monitored for disease progression, with the primary measure being progression-free survival for up to about 48 months. Secondary outcomes include response rates, disease control, overall survival, and safety over up to 72 months. Tumor tissue samples will be collected for research, and participants will undergo regular evaluations including imaging and laboratory tests. The study follows patients for a long period to assess treatment effects and safety.

Researchers are investigating the effects of a high-fat mixed meal containing a whey protein-enriched milk fat globule membrane (MFGM) supplement on heart and brain health markers in middle-to-older-aged, postmenopausal women who are overweight and at moderate risk for cardiovascular disease. This randomized, single-blind, placebo-controlled crossover study aims to understand how this specific nutritional ingredient influences post-meal responses related to cardiovascular and cognitive health. Participants will attend two approximately 8-hour visits. During each visit, they will consume a high-fat meal containing about 75 grams of refined palm oil fat supplemented either with a whey protein-enriched MFGM powdered ingredient or a placebo whey protein-based powdered ingredient without MFGM. The meals are matched for energy and protein content and given in random order with a washout period of at least 21 days between visits. During each visit, researchers will take body measurements and periodically assess heart health through blood pressure and blood vessel stiffness tests. Blood samples will be collected at multiple time points before and after the meal, over a 6-hour period, to measure changes in blood fats, glucose, insulin, and inflammatory markers. Participants will also complete computer-based tests to assess mood and cognitive function. The study will monitor how the supplement affects these heart and brain health markers in the hours following a meal.

Gastric adenomas with low-grade dysplasia (LGD) are precancerous stomach lesions with a lower risk of progressing to cancer compared to high-grade dysplasia. This trial aims to compare two common endoscopic treatments, argon plasma coagulation (APC) and endoscopic mucosal resection (EMR), to see if APC is as effective as EMR in preventing local recurrence of these small lesions measuring 1 cm or less. The study addresses current uncertainties and differing international guidelines on managing these lesions. Participants will be randomly assigned to receive either APC, which uses ionized argon gas to coagulate tissue without cutting, or EMR, which involves lifting and cutting out the lesion. EMR allows detailed pathological examination but may take longer and have more complications, while APC is simpler, quicker, and usually less invasive but lacks tissue for pathology. After treatment, all participants receive standard medical care and are monitored for any complications. Participants will return for follow-up endoscopies at 3 and 12 months to check the treated area and take biopsies if needed to detect recurrence. Researchers will record the local recurrence rate at 12 months as the main outcome, along with procedure-related complications like bleeding or perforation, procedure time, and recovery experience. The trial will provide important evidence to guide treatment choices for patients with small gastric adenomas.