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Carcinoma in Situ clinical trials

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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: NCT04248179 Completed - Breast Cancer Clinical Trials

The Ultrasound-guided Multiple-injection Costotransverse Block for Mastectomy and Primary Reconstructive Surgery.

Start date: November 29, 2019
Phase: Phase 4
Study type: Interventional

The investigators have developed a novel ultrasound-guided nerve block indicated primarily for breast cancer surgery that mimic a thoracic paravertebral block (TPVB) - hitherto the internationally accepted regional anesthesia golden standard for anesthesia of the hemithorax - but hypothetically without the risks of adverse events associated with the TPVB (i.e. pneumothorax, risk of bleeding in the thoracic paravertebral space, random and unmanageable epidural spread etc.). The investigators have already tested the anatomical- and block execution hypothesis in a randomized cadaveric study, and the investigators now have anatomical proof of concept for the functionality of the block technique. The investigators have also conducted a small clinical pilot study with very promising results. The investigators wish to conduct a randomized, placebo controlled and double-blind study, comparing the effect of the ultrasound-guided multiple-injection costotransverse block (MICB) vs. placebo. The aim with this study is to investigate the efficacy of the MICB vs. placebo in patients undergoing unilateral mastectomy and primary reconstructive surgery due to breast cancer or ductal carcinoma in situ. The hypothesis is, that the unilateral MICB will significantly reduce the opioid consumption during the first 24 postoperative hours and significantly reduce the Numerical Rating Scale pain score (0-10) and opioid related side effects.

NCT ID: NCT04245657 Completed - Breast Cancer Clinical Trials

Factors Affecting Functionality in Breast Cancer Survivors

Start date: December 17, 2019
Phase:
Study type: Observational

Breast cancer is the most frequent cancer type in women globally. In conjunction with the new developments, breast cancer survival has increased therefore the management of long-term complications has gained importance. Breast cancer survivors can face the loss of muscle strength, increased fatigue and diminished physical function associated with treatment-related long term effects and psychological affection and thereby reduced quality of life. Upper extremity lymphedema or breast cancer-related lymphedema (BCRL) is one of the most prominent long term complications which affects breast cancer survivors in many ways after breast cancer surgery. It has been reported that breast cancer survivors with BCRL have the lower muscle strength and more activity limitations when compared to the ones free of BCRL. In BCRL, affected extremity has been found to 36% more weaker when compared to the unaffected side. Fatigue is one of the most prominent symptoms when considering cancer-related symptoms in cancer survivors. It has been stated that increased fatigue is correlated with increased activity limitation and deterioration in physical function. The hand-grip test which is frequently used in the assessment of decreased muscle function has been stated as a reliable and repeatable test in breast cancer survivors. In addition, this test is frequently applicable to assess mortality, physical and functional capacity, symptoms after surgery and to designate an exercise program. There are studies that investigate upper extremity function associated with hang-grip strength in breast cancer survivors. Yet, there is a lack of the objective result or conclusion of the BCRL effect on upper extremity function which is assessed with hang-grip strength when compared without BCRL. Therefore, this study is planned to investigate of cumulative effects of factors such as lymphedema severity, age, fatigue, body mass index, muscle strength, physical activity level, pain level, exercise benefits/barriers scale score on hand-grip strength related upper extremity functionality in breast cancer survivors.

NCT ID: NCT04209010 Completed - Breast Cancer Clinical Trials

Immediate Breast Reconstruction With Acellular Dermal Matrix

Start date: December 1, 2012
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to contribute to the knowledge regarding immediate implant-based BR by investigating whether the one-stage technique with ADM is superior to the two-stage expander to implant technique. Primary endpoint in first publication is postoperative complications, secondary endpoint is patient and investigator assessed aesthetic outcome. Primary endpoint in second publication is cost, secondary endpoint is patient reported outcome measures.

NCT ID: NCT04197180 Recruiting - Clinical trials for Gastric Low Grade Intraepithelial Neoplasia

Hybrid APC for Gastric Low Grade Intraepithelial Neoplasia

HybridAPC
Start date: March 1, 2020
Phase: N/A
Study type: Interventional

This cohort study aims to investigate the clinical efficacy and safety of Hybrid APC for treatment of gastric low grade intramucosal neoplasia.

NCT ID: NCT04170257 Recruiting - Clinical trials for Esophageal Squamous Cell Carcinoma

Performance of White Light, NBI and Iodine Staining Endoscopy in the Diagnosis of Esophageal Lesions

Start date: October 18, 2019
Phase: N/A
Study type: Interventional

The investigators aim to evaluate the performance of Narrow Band Imaging (NBI) endoscopy in Esophageal Squamous Cell Carcinoma (ESCC) screening, as compared to the currently used White Light Endoscopy (WLE) and Lugol's Iodine Staining Endoscopy (ISE). NBI is a simple, safe and non-invasive technique, which can provide real-time optical staining for suspicious lesions. This trial is designated to enroll 10000 participants from five centers located in different regions (North, West and South) in China, which would provide real-world evidence for the recommendation of endoscopic diagnostic technique used in ESCC screening projects.

NCT ID: NCT04169542 Recruiting - COVID-19 Infection Clinical Trials

Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients With Breast Cancer Undergoing Breast Surgery

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

This study investigates the impact of COVID-19 pandemic on out-of-pocket costs, lost wages, and unemployment in patients with breast cancer undergoing breast surgery. Post-mastectomy reconstructive patients are at high risk for financial toxicity (adverse effects of escalating health care cost on well-being). The goal of this study is to collect information about financial costs patients may have as a result of surgical treatment for cancer with or without breast reconstruction and to learn if COVID-19 affects patient costs of breast reconstruction. This may help researchers demonstrate the financial consequences of undergoing breast surgery.

NCT ID: NCT04164082 Recruiting - Clinical trials for Stage 0a Bladder Cancer AJCC v8

Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer

Start date: March 18, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Chemotherapy drugs, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine may delay the return of BCG-unresponsive bladder cancer for longer period compared to gemcitabine alone.

NCT ID: NCT04153266 Completed - Quality of Life Clinical Trials

Oral Epithelial Dysplasia Informational Needs Questionnaire

ODIN-Q
Start date: October 31, 2018
Phase:
Study type: Observational

Background: Oral epithelial dysplasia (OED) is a condition with an increased risk of oral cancer. Due to the current changes in the factors associated with these diseases (because of human papillomavirus), it is expected that those who have no history of smoking or alcohol, young (<50 years old), and white male would be commonly affected. Those individuals require a higher need for information, preferred a more active role in decision-making, and have a longer lifespan than older individuals. There remain no detailed studies of whether the informational needs delivered to patients with OED met their needs or indeed what information such patient may wish. A few tools are available to evaluate the IN of patients with head and neck disorders. However, the items of these instruments were dedicated to a particular disease (e.g. cancer) and hence are not applicable to be used for OED. Project aims: To evaluate the psychometric properties of the Oral Epithelial Dysplasia Informational Needs Questionnaire (ODIN-Q), developed and revised in the preliminary work for the proposed study, in a cohort of patients with OED. Timescale: 19 months. Clinical significance: This questionnaire can be useful in clinical practice. It could help to meet the patient's information needs and plan educational interventions for those showing unmet needs.

NCT ID: NCT04144023 Recruiting - Clinical trials for Breast Ductal Carcinoma In Situ

A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ

Start date: June 27, 2019
Phase: Phase 1
Study type: Interventional

This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting against breast cancer.