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Endometrial Neoplasms clinical trials

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NCT ID: NCT04290299 Recruiting - Endometrial Cancer Clinical Trials

Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive

Start date: September 15, 2015
Phase:
Study type: Observational [Patient Registry]

Approximately one fourth of cases of endometrial cancer (EC) are diagnosed in premenopausal women, of whom approximately 40% wish to preserve their fertility. When arising in young women, EC usually presents with favorable prognostic features, as a focal, well differentiated endometrioid tumor, with minimal or absent myometrial invasion. This profile corresponds to the Type 1 EC, which correlates with the estrogen/progesterone receptor positive (ER+/PR+) pattern. On the other hand, these patients frequently present with clinical signs of a hyperestrogenism (chronic anovulation, infertility, obesity). Primary progestin therapy has been demonstrated to be effective in early well differentiated tumors and in poor operative candidates with response rates ranging from 58-100%.Currently, the therapeutic approach to an early stage EC consists of a staging laparotomy/laparoscopy, including a total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH-BSO), peritoneal washings, and lymphadenectomy (pelvic and aortic), depending on the pathological risk profile pre- and intraoperatively determined. Therefore, the current standard of surgical approach is preclusive of fertility. The worldwide experience and data on conservative management of EC are, however, still limited. Most of reports based on cases retrospectively collected, harboring potential methodological bias, using different treatments and drugs, and with insufficient follow-up. Some systematic reviews have been published in the last decade, trying to summarize the literature data. Therapeutic results seem to be promising with a regression rate of approximately 75% and relapse occurring in 25-40% of cases, with anecdotical reports of deaths of disease (DOD). The fertility outcome was, however, not satisfying with about 30% pregnancy rate in patients attempting to conceive, and an overall low rate of assisted reproductive techniques (ART) despite the subfertile clinical profile.Therefore, there is a need for a prospective, multicentre cooperative project able to systematically collect data from consecutive patients treated according to defined (not necessarily identical) protocols, concerning the oncological, as well as, the obstetrical outcomes. Moreover, this project could represent the "template" in which a pretreatment fertility counseling, psychological support, and definitive surgery are routinely included according to shared criteria.

NCT ID: NCT04281043 Completed - Quality of Life Clinical Trials

Quality of Life After Robotic Surgery for Endometrial Cancer

QoL
Start date: June 15, 2019
Phase:
Study type: Observational

The purpose of this study is to investigate how robotic assisted laparoscopic surgery affects the quality of life of women who are treated with primary surgery for endometrial cancer. So far, very little has been published and basically no long-term follow-up. Included patients respond to questionnaires preoperatively, 2 weeks after surgery and 3 months and 12 months after surgery. Each patient thus answers the questionnaires (the same) on four occasions. The questionnaires used are validated and used extensively internationally. The first survey has two parts, QLQ30 and the module for endometrial cancer EN24. In addition the study includes use PHQ -9 and GAD 7.

NCT ID: NCT04278183 Not yet recruiting - Obesity Clinical Trials

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

WLS-TLH
Start date: May 1, 2021
Phase:
Study type: Observational

In the United States, the most significant risk factors for endometrial cancer (and EIN) are obesity and metabolic syndrome, given their high prevalence in this population. Given the high survival rate in early stage endometrial cancer, these patients, specifically those that are obese and have metabolic syndrome, are more likely to die of other causes. By treating an obese patient's endometrial cancer, one cause of death may be prevented but an important opportunity is missed to improve overall survival after cancer treatment. Concurrent laparoscopic hysterectomy and weight loss surgery is not an experimental procedure. This combined procedure has successfully been performed at our institution numerous times but there is a lack of data describing clinical outcomes and ideal patient selection. The goal of this study is 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 Weight Management and Metabolic Surgery. Secondary outcomes will include short-term and long-term obesity-related outcomes (i.e., better diabetes control, lowered cholesterol, lowered baseline blood pressure) as well as whether quality of life is improved post-operatively compared to preoperatively in concurrent surgery.

NCT ID: NCT04278144 Active, not recruiting - Clinical trials for HER2-positive Breast Cancer

A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors

Start date: February 24, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies

NCT ID: NCT04276532 Recruiting - Prognosis Clinical Trials

Sentinel Lymph Node Sampling for Patients With Middle-high Risk Endometrial Cancer Confined to the Uterus

Start date: February 13, 2020
Phase: N/A
Study type: Interventional

Aim To investigate the effect of sentinel lymph node (SLN) sampling on the prognosis of patients with middle-high risk endometrial cancer obviously confined to the uterus before surgery.

NCT ID: NCT04272034 Active, not recruiting - Cervical Cancer Clinical Trials

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors

Start date: March 26, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.

NCT ID: NCT04269200 Active, not recruiting - Clinical trials for Endometrial Neoplasms

Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer

DUO-E
Start date: May 5, 2020
Phase: Phase 3
Study type: Interventional

A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.

NCT ID: NCT04262180 Active, not recruiting - Physical Activity Clinical Trials

Physical Activity Promotion for Breast and Endometrial Cancer Survivors

Start date: November 9, 2020
Phase: N/A
Study type: Interventional

Many breast and endometrial cancer survivors do not get enough physical activity. Technology-based interventions can be inexpensive and easy to scale up, however they are not effective for all women. The purpose of this study is test an adaptive physical activity intervention approach that reserves the most resources and support for women who do not fare well with a lower-cost, minimal intervention. The results from this trial will inform the development of scalable physical activity interventions for breast and endometrial cancer survivors.

NCT ID: NCT04258813 Recruiting - Hypertension Clinical Trials

Onco-primary Care Networking to Support TEAM-based Care

ONE TEAM
Start date: June 14, 2021
Phase: N/A
Study type: Interventional

The proposed ONE TEAM Study is an 18-month, cluster randomized controlled trial. This study will use a sequential multiple assignment randomized trial (SMART) design with a second randomization for the intervention group using a dynamic treatment regimen approach. The investigators propose to randomize 800 adults with newly-diagnosed selected cancers treated with curative intent (breast, prostate, colorectal, endometrial, non-small cell lung, and endometrial) and with >1 selected cardiovascular disease (CVD) comorbidity (hypertension, type 2 diabetes mellitus, hypercholesterolemia). Participants will be enrolled through Duke Cancer Institute and two community-based oncology practices, both settings serving socio-demographically diverse populations. The unit of randomization will be the PCP clinic; there will be ~80 PCP clinics across North Carolina involved in the study. The overarching goals of this study are to improve chronic disease management and communication among cancer survivors by engaging PCPs as active members of the cancer care team and reframing the message to cancer survivors and providers. A diversity supplement with retrospective and qualitative components has been added to abstract older adults with solid tumors who underwent cancer surgery at DUHS. Aims include (1) to estimate the prevalence of cardiovascular complications ≤90 postoperative days among older adults with solid tumors undergoing surgery, and its association with care coordination between surgical providers and PCPs ; (2) to develop a risk index for cardiovascular complications ≤90 days of surgery among older adult patients with a solid tumor; and (3) to Assess experience and perceptions of PCPs on care coordination with surgical providers of older adults with a solid tumor following cancer surgery.

NCT ID: NCT04257045 Active, not recruiting - Breast Carcinoma Clinical Trials

Factors Influencing Cascade Testing Among Women With Hereditary Gynecological Cancers and Their Relatives

Start date: August 21, 2019
Phase:
Study type: Observational

This trial collects information about factors that affect communication of genetic test results, decision-making, and access to genetic testing in women with hereditary gynecological cancers. Studying individuals who are positive for a genetic mutation and immediate biological family members (including a parent, full-sibling, or child) may help identify cancer genes and other persons at risk.