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Carcinoma in Situ clinical trials

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NCT ID: NCT06191133 Not yet recruiting - Clinical trials for Cervical Intraepithelial Neoplasia

Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

Start date: August 1, 2024
Phase: Phase 1
Study type: Interventional

Normally, p53 helps prevent tumors from forming in the body. Early studies have shown that Fenofibrate, a cholesterol-lowering drug, can restore normal function to p53 and can change the metabolism of HPV-positive tumors in a way that stops the growth of tumors. The purpose of this study is to understand how Fenofibrate can be used to treat HPV-positive cervical cancers and cervical dysplasia. Researchers will examine collected tissue samples and investigate various genes and proteins to see whether Fenofibrate has an effect on HPV-positive cervical cancers and cervical dysplasia.

NCT ID: NCT06184750 Not yet recruiting - Breast Carcinoma Clinical Trials

Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial

Start date: November 26, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial evaluates response-guided low-dose tamoxifen for reducing breast density in women who are at higher than average risk for breast cancer. Increasing breast density is a well established risk factor for breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen has been shown to reduce breast density, even at reduced dosages, and is approved for the prevention of breast cancer.

NCT ID: NCT06033092 Not yet recruiting - Clinical trials for Ductal Carcinoma in Situ

Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion

TOLERANT
Start date: May 2024
Phase: Phase 2
Study type: Interventional

Circulating levels of Sex Hormone Binding Globulin (SHBG) are significantly associated with a decreased risk of breast cancer. The main aim of this clinical trial is to verify whether Low Dose Tamoxifen (LDT) increases circulating levels of SHBG more than lifestyle intervention (LI) with or without intermittent caloric restriction (ICR) after 6 months in women at increased risk of breast cancer (i.e., healthy participants carriers of a germline pathogenic/likely pathogenetic variant in at least one of the following genes: BRCA1, BRCA2, PALB2, ATM, CHEK2, CDH1, RAD51C or RAD51D, or with > 5% breast cancer risk at 10 years, using the Tyrer Cuzick or the Breast Cancer Surveillance Consortium Risk models or with a recently resected intraepithelial neoplasia of the breast (IEN). The secondary aims are: - to verify whether ICR significantly modulates primary and secondary endpoints such as Homeostasis Model Assessment (HOMA) index, immune and inflammatory markers, lipid profile, Adiponectin/Leptin (A/L) ratio, quality of life (QoL), Body mass index (BMI), fat body composition, safety and toxicity; - to verify whether LDT significantly modulates secondary endpoints, such as HOMA-index, immune and inflammatory markers, lipid profile, A/L ratio, QoL, BMI, fat body composition, safety and toxicity; - to investigate differences in microbiome composition by arms and the effect of changes in microbiome on QoL taking into account circulating biomarkers, cytokines, immune modulators, and inflammatory proteins in serum; - to investigate MD (Mammographic Breast Density) changes by LDT vs. LI, with or without ICR. This aim will be performed in a subgroup of participants (not all the participants will undergo mammography due to younger age).

NCT ID: NCT05941520 Not yet recruiting - Breast Carcinoma Clinical Trials

Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer

Start date: October 8, 2024
Phase: Phase 2
Study type: Interventional

This phase IIA trial compares the effect of acolbifene versus low dose tamoxifen in preventing breast cancer in premenopausal women at high risk for developing breast cancer. The usual approach for patients at increased risk for breast cancer is to undergo yearly breast magnetic resonance imaging (MRI) or ultrasound in addition to yearly mammogram. Premenopausal women at very high lifetime risk for breast cancer (greater than 50%) can consider preventive removal (mastectomy) of both breasts. Premenopausal women age 35 or older with a prior diagnosis of atypical hyperplasia, lobular carcinoma in situ, or an estimated 10-year risk of greater than or equal to 3% or estimated 10-year risk of greater than or equal to 2-5 times that of the average woman (depending on age) may be advised to consider five years of standard dose tamoxifen. Standard dose tamoxifen is four times the dose used in this study. Estrogen can cause the development and growth of breast cancer cells. Acolbifene and tamoxifen blocks the use of estrogen by breast cells. This study may help researchers measure the effects of acolbifene and low dose tamoxifen on markers of breast cancer risk in mammogram imaging, breast tissue, and in blood samples.

NCT ID: NCT05858021 Not yet recruiting - Clinical trials for Anal Intraepithelial Neoplasia

COrSIcA: Disease Measurement

Start date: July 3, 2023
Phase:
Study type: Observational

Anal cancer can be prevented through detection and treatment of a recognised precancerous lesion, known as anal intra-epithelial neoplasia (AIN), specifically the anal high-grade squamous intra-epithelial lesion (aHSIL) subtype. Assessment of changes in disease burden is an important feature in the clinical evaluation of a treatment. Existing trials in aHSIL have predominantly used disease response outcomes based on histological and cytological changes to measure the effects of treatment. Several limitations to this approach have been identified. Lesion characteristics such as lesion size and number represent potential indicators of disease response to treatment and might overcome some of the limitations. We aim to develop a disease measurement instrument capable of describing disease burden such that it can be used to evaluate disease response to treatment in addition to histological and cytological based measurements further strengthening the quality of disease response outcomes. The disease measurement instrument will be developed over 4 stages: 1. A meeting of AIN experts to determine a longlist of lesion measurement items capable of capturing disease burden; 2. A series of disease assessments will be undertaken in participants known to have aHSIL to assess disease burden using the measurement items identified in stage 1; 3. Data analysis to determine the best performing measurement items and comprise a disease measurement instrument; 4. Pilot-testing of the proposed disease measurement instrument. Two trained disease assessors (experienced clinicians familiar with the assessment of anal intraepithelial lesions) will assess disease burden per participant. Disease burden will also be captured photographically. We will undertake disease assessments on 20-30 participants. By analysing the results of the clinician assessments and digital analysis of the photographic representation of disease burden, we will be able to determine the most acceptable, feasible, reliable and reproducible ways of measuring disease burden and use these to inform a disease measurement instrument.

NCT ID: NCT05208775 Not yet recruiting - Clinical trials for Esophageal Carcinoma in Situ AJCC V7

A Comparative Study of Endoscopic Submucosal Dissection and Photodynamic Therapy for Early Esophageal Cancer

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this study was to compare the efficacy and safety of Photodynamic therapy (PDT) and Endoscopic submucosal (ESD) dissection in the treatment of early esophageal cancer.

NCT ID: NCT05178498 Not yet recruiting - Breast Carcinoma Clinical Trials

Impact of Dietary Inflammatory Potential on Breast Cancer Risk

Start date: September 30, 2023
Phase:
Study type: Observational

This study evaluates the association of dietary inflammatory potential with breast cancer risk. Information collected in this study may help doctors to identify modifiable risk factors, screen high risk patients early, improve prevention strategies, and provide timely intervention for early therapeutic management as needed.

NCT ID: NCT04695015 Not yet recruiting - Melanoma (Skin) Clinical Trials

Research of Pathological Imaging Diagnosis of Ocular Tumors Based on New Artificial Intelligence Algorithm

Start date: December 31, 2020
Phase:
Study type: Observational

The purpose of this study is to establish a standardized process for obtaining digital pathological image information of ocular tumors; use modern pathological techniques to obtain the co-expression information of multiple biomarkers in the pathological tissues of ocular tumors, and finally construct standardized digital ocular tumors with biomarkers Pathology image database.

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: NCT04055142 Not yet recruiting - Clinical trials for High-grade Anal Intraepithelial Neoplasia

Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males

TreatAIN
Start date: September 2019
Phase: Phase 3
Study type: Interventional

This study wants to demonstrate the non-inferiority in terms of efficacy and safety of treatment with cidofovir (1%) in topical ointment or topical sinecatechins (10%) ointment versus electrocoagulation (control group) for the treatment of high-grade anal intraepithelial neoplasia (HGAIN). The target patients are Human Immunodeficiency Virus (HIV)-infected homosexual males. All these patients will be randomized by a proportion of 1:1:1 setting up 3 different parallel arms of the study: control group, cidofovir (1%) group and topical sinecatechins (10%) group.