Clinical Research Directory

SHAPE-ENDO: Multimodal Pre-Surgical Optimization in Patients With Obesity and Early-Stage Endometrial Cancer (Phase 1)

SHAPE-ENDO is a prospective, single-center, low-intervention, non-randomized, single-arm clinical trial conducted at Hospital Universitari de Bellvitge (Barcelona, Spain). The study is designed to evaluate a protocolized multimodal pre-surgical optimization strategy in women with severe obesity (BMI ≥40 kg/m²) and atypical endometrial hyperplasia/endometrial intraepithelial neoplasia or early-stage, low-risk endometrioid endometrial cancer. The strategy is intended for selected patients in whom immediate surgery may be associated with increased perioperative risk due to obesity and comorbidities. Participants will receive a structured multimodal optimization program aimed at improving metabolic and functional status while maintaining local oncologic control. The multimodal strategy includes authorized treatments used according to clinical indication, product labeling, current guidelines, and physician judgment: semaglutide/GLP-1 receptor agonist therapy for metabolic optimization, local hormonal treatment with a levonorgestrel-releasing intrauterine device with or without oral progestins, structured nutritional intervention, adapted physical exercise, and scheduled clinical, imaging, and histological surveillance. The primary objective is to estimate the proportion of participants who achieve predefined pre-surgical optimization criteria after the multimodal strategy, including clinically relevant weight loss and/or reduction to BMI \<40 kg/m², absence of tumor progression, and acceptable anesthetic/surgical risk. Secondary outcomes include histological response, metabolic and anthropometric changes, treatment adherence, safety, health-related quality of life, feasibility of subsequent surgery, perioperative outcomes, and exploratory long-term survival outcomes. Participants will be followed during a 28-54 week optimization period. Long-term follow-up will assess recurrence, survival, quality of life, and metabolic outcomes. Exploratory adjusted comparisons may be performed against a historical cohort of patients with similar baseline characteristics previously treated at the same institution.

Endometrial Cancer Vaginal Fluid Specimen Collection Study

This is a multicenter, prospective, specimen collection study for development and evaluation of tests used to detect endometrial cancer, other cancers, or their causes.

Tirzepatide in Women With Obesity and Endometrial Intra-epithelial Neoplasia or Grade 1 Endometrial Cancer

The goal of this study is to determine the anti-proliferative effect of tirzepatide on the endometrium of patients with endometrial intra-epithelial neoplasia (EIN) and Grade 1 endometrial cancer (EC), by comparing archival endometrial biopsy samples of patients randomized to tirzepatide versus SOC (no tirzepatide) to their post-intervention hysterectomy specimens. It was hypothesized that tirzepatide may help fight tumors in two ways: indirectly, by improving the body's overall metabolic health, and directly, by acting on abnormal cells in the uterus, such as those found in endometrial intraepithelial neoplasia (EIN) and endometrial cancer (EC). EIN is considered a precursor to EC. Tirzepatide may influence the tumor environment through key biological pathways related to insulin, fat metabolism, and mTOR signaling, all of which are often disrupted in individuals with obesity. Because both EIN and EC are strongly linked to obesity, tirzepatide could offer a promising dual benefit, promoting weight loss while also slowing or stopping tumor growth. The primary goal of this study is to determine whether tirzepatide can reduce cell proliferation in the lesions or tumors of patients with EIN and early- stage (Grade 1) EC. Patients will either be randomized to receive tirzepatide or no tirzepatide for 4 weeks prior to their hysterectomy surgery. Patients randomized to the tirzepatide arm will be given a glucose monitoring system for continuous monitoring with real-time alarms to alert of hypoglycemia. Patients will complete diaries during treatment to document compliance with medication and record any side effects. Patients will undergo standard of care surgery 7-10 days after the final dose of tirzepatide in order to minimize the risk of gastroparesis. During surgery (hysterectomy), an endometrial biopsy for uterine biopsy tissue will be collected. At the 1-month post-operation visit, patients from both arms will be referred to an institutional weight loss clinic.

InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer

This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer. * The objective of this study is to identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal. * The ultimate goal is to identify novel markers of early detection and risk stratification to drive potential therapeutic approaches to intercept progression to cancer.

Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia

To assess the feasibility of an expedited referral process for the obese endometrial cancer or EIN patient from her gynecologic oncologist to the Brigham Center for Metabolic and Bariatric Surgery (CMBS) in order to undergo concurrent weight loss surgery and hysterectomy within 8 weeks of first appointment with a gynecologic oncologist (or 12 weeks for EIN patients).

A Multi-center Prospective Study on the Oncological and Reproductive Outcomes and Quality of Life in Young Woman After Fertility-sparing Treatment of Endometrial Cancer and Endometrial Intraepithelial Hyperplasia

We will investigate the safety and efficiency of fertility-sapring treatment in ypung women witg endometrial cancer and endometrial intraepithelial hyperplasia