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BRCA1 Mutation clinical trials

View clinical trials related to BRCA1 Mutation.

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NCT ID: NCT04890327 Completed - Breast Cancer Clinical Trials

Web-based Family History Tool

Progeny
Start date: September 9, 2019
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to determine if a web-based tool that collects family health history is useful for patients being seen in a gynecologic oncology office setting. This research study is being done because collecting a comprehensive family health history is critical as it allows physicians to appropriately refer patients for genetic counseling and genetic testing. However, prior research indicates that the family health history collected in clinical settings is often inadequate to truly assess the risk of genetic disease. Therefore we plan to explore a web-based program that guides patients through the collection of their family health history and uses this information to create clear concise pedigrees (family tree information) and risk assessment models that can be used by a physician during the office visit.

NCT ID: NCT04866992 Completed - Clinical trials for Anatomic Stage II Breast Cancer AJCC v8

Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy (SPrNSM)

SPrNSM
Start date: February 1, 2020
Phase:
Study type: Observational

This is a prospective registry trial to determine the outcomes of single port robot-assisted nipple sparing mastectomy (SPrNSM) utilitzing the SP da Vinci surgical system.

NCT ID: NCT04683068 Completed - BRCA1 Mutation Clinical Trials

Promoting Men's Adherence to BRCA1/2 Germline Genetic Testing

BRCA-MEN
Start date: January 10, 2021
Phase: N/A
Study type: Interventional

BRCA1- and BRCA2-associated Hereditary Breast and Ovarian Cancer Syndrome (HBOC) increases the relative and absolute risk of developing breast and ovarian cancer and, to a lesser extent, prostate and pancreatic cancer. Men face BRCA-related cancer risks as women do, although with a different magnitude, and they may also transmit the mutations to their children. Notwithstanding, men have not received much attention since now. They are under-tested compared to women and the communication is not tailored on their needs. Research on the psychological determinants of men's informed decision-making is particularly lacking as well as experimental evidence on the efficacy of tailored messages on men's needs. Applying principles of the Health Action Process Approach (HAPA), the present protocol proposes a study with the aim to test psychological variables influencing men's decision-making. Moreover, the proposed research intends to test the efficacy of two messages through a randomized experimental study. A total of 264 participants will be involved, among the men's relatives of women with verified germline mutations. The study entails a pre- post- evaluation with randomization of the participants in two conditions corresponding to the two messages. The expected results provide answers related to the impact of action self-efficacy, outcome expectancy (personal or familiar), risk perception, health risk aversion, intolerance of uncertainty, perceived barriers, and coping self-efficacy on informed decision-making. Data gathered from this study may inform health care providers, policymakers, and public health managers about the communication strategy for men and about the psychological variables influencing decision-making.

NCT ID: NCT04651920 Completed - Clinical trials for Epithelial Ovarian Cancer

A Study on Association Between HR Genes and the HRD Status in Chinese Epithelial Ovarian Cancer

Start date: November 26, 2020
Phase:
Study type: Observational

The association between homologous recombination (HR) gene mutations and homologous recombination deficiency (HRD) status in Chinese epithelial ovarian cancer (EOC) patients is little known. This study would recruit 400 Chinese EOC patients with known targeted gene mutations via a multi-panel testing of 27 genes, including BRCA1/BRCA2. All patients accept evaluation of HRD model, which is based on the loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST). The mutated genes, HRD score model and their relationship with the prognosis, would provide a full description of for the Chinese EOC patients, and a potential explanation of platinum-resistance in such population.

NCT ID: NCT04108117 Completed - Breast Cancer Clinical Trials

Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction

SORI
Start date: May 14, 2020
Phase:
Study type: Observational

Robotic mastectomy with immediate reconstruction was introduced by Toesca et al. in 2015. Since then, several studies have reported the safety and feasibility of robotic nipple-sparing mastectomy with immediate reconstruction. However, most studies were conducted by single centers and had small samples. Furthermore, there is a lack of studies comparing surgical and oncologic outcomes between robotic nipple-sparing mastectomy and conventional nipple-sparing mastectomy. For this reason, this study evaluates surgical and oncologic outcomes of robotic nipple-sparing mastectomy with immediate reconstruction using international multi-center data.

NCT ID: NCT04012229 Completed - Breast Cancer Clinical Trials

IMpact of Breast cAncer Gene Status on Survival in Adjuvant Breast Cancer (IMBASSA)

IMBASSA
Start date: July 28, 2017
Phase:
Study type: Observational

Relationship between the presence of the BRCA mutation (BReast Cancer) and outcomes is unclear in high-risk early breast cancers (BC). This study is a multi-center retrospective cohort of patients treated in region Franche-Comté for an early BC by neoadjuvant and/or adjuvant chemotherapy. The primary aim was to describe clinical and pathological characteristics considering BRCA mutated (BRCAm) patients versus BRCA wild type (BRCAwt) patients or untested patients. The second objective was to assess the prognostic impact of germinal BRCAm in this high-risk population.

NCT ID: NCT03684733 Completed - MRI Clinical Trials

Magnetic Resonance Breast Tissue Characterisation to Improve Risk Stratification for Breast Cancer

MR-BTC
Start date: March 13, 2017
Phase:
Study type: Observational

This is a combination retrospective/prospective observational study with two arms:

NCT ID: NCT03495609 Completed - BRCA1 Mutation Clinical Trials

Use of Recombinant hCG to Prevent Breast Cancer in BRCA1 and BRCA2 Carriers

Start date: February 17, 2016
Phase: Phase 4
Study type: Interventional

Specific aim: To establish the proof of principle that treatment of "high breast cancer risk" women with recombinant human chorionic gonadotropin (r-hCG) will change their breast epithelium's high risk genomic profile to one similar to that identified in women with a history of early full first term pregnancy.

NCT ID: NCT03470402 Completed - Breast Cancer Clinical Trials

Decision Support for BRCA Testing in Ethnically Diverse Women

Start date: December 13, 2017
Phase: N/A
Study type: Interventional

The objective of this study is to expand genetic testing for hereditary breast and ovarian cancer syndrome to a broader population of high-risk women by prompting appropriate referrals from the primary care setting with the use of an electronic health record-embedded breast cancer risk navigation (BNAV) tool. To address patient-related barriers to genetic testing, the investigators developed a web-based decision aid, RealRisks, which is designed to improve genetic testing knowledge, accuracy of breast cancer risk perceptions, and self-efficacy to engage in a collaborative dialogue about genetic testing. The study design is a randomized controlled trial of patient educational materials and provider electronic health record (EHR) notice alone (control arm) or in combination with RealRisks and BNAV (intervention arm). The investigators hypothesize that combining the patient-centered RealRisks with the provider-centered BNAV will increase appropriate uptake of genetic counseling. The investigators also hypothesize that genetic counseling decisions will be more informed, and result in less decision conflict and improved shared decision making.

NCT ID: NCT03428399 Completed - Breast Cancer Clinical Trials

Depression and Body Image Distress Following Mastectomy With Reconstruction

Start date: October 12, 2017
Phase:
Study type: Observational

Mastectomy is a major surgery that can have a profound effect on women's psychosocial wellbeing, including elevated depression and body image distress. Reconstructive breast surgery aims to improve patients' psychosocial adjustment to mastectomy, yet for some women substantial distress persists after reconstruction. However, very little is known about risk or protective factors for persistent depression or body image distress following mastectomy with reconstruction. The present study aims to address this critical gap. In women undergoing mastectomy with breast reconstruction, the investigators will assess risk and protective factors for post-surgery depression severity and body image distress.