Frauenfeld

Researchers are investigating whether tailored axillary surgery TAS combined with axillary radiotherapy ART is better than the current standard treatment, axillary lymph node dissection ALND, for patients with clinically node-positive breast cancer undergoing upfront surgery. The study aims to see if TAS plus ART improves arm-related quality of life and reduces the occurrence of lymphedema two years after treatment. This question arises because ALND, although standard, can cause significant side effects, and TAS selectively targets affected lymph nodes with potentially less harm. Participants will be randomly assigned to one of two groups one receiving ALND, which involves removing lymphatic tissue within the axilla, and the other receiving TAS with ART, where surgery removes sentinel and suspicious lymph nodes followed by targeted axillary radiotherapy. All participants will also receive breast or chest wall irradiation after breast-conserving surgery. The study compares these approaches to assess their impact on arm health and quality of life. During the trial, participants will be followed for at least two years to assess changes in arm-related quality of life and monitor for lymphedema. Researchers will collect quality of life questionnaires and clinical evaluations over this period. The study is sponsored by University Hospital Basel and aims to complete primary outcome assessments by the end of 2029, with overall study completion planned for 2037.

Researchers are investigating the best approach to treat low-risk patients with isolated subsegmental pulmonary embolism SSPE, a type of blood clot in small lung arteries. The study aims to determine whether monitoring patients without anticoagulation is as safe and effective as giving anticoagulant medication. This is important because many patients currently receive anticoagulants that carry a risk of bleeding, but it is unclear if all patients with isolated SSPE need this treatment. Patients in the trial are randomly assigned to one of two groups. One group receives the anticoagulant drug rivaroxaban, starting with 15 mg twice daily for 21 days, then 20 mg once daily for a total of 90 days. The other group receives a placebo matching the same schedule. The trial compares clinical surveillance without anticoagulation to anticoagulation treatment to assess safety and effectiveness. Participants will be followed for 90 days after randomization to monitor for recurrent venous thromboembolism, significant bleeding events, and overall survival. Researchers will track these outcomes through clinical assessments and safety monitoring. This study is designed to evaluate if careful monitoring alone is a safe alternative to anticoagulation in selected patients with isolated SSPE, potentially reducing bleeding risks from treatment.

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

Researchers are evaluating the effectiveness of trastuzumab deruxtecan T-DXd combined with either rilvegostomig or pembrolizumab compared to standard chemotherapy with carboplatin and paclitaxel plus pembrolizumab in treating women with HER2-expressing, mismatch repair proficient pMMR, advanced or recurrent endometrial cancer. This Phase III study focuses on progression-free survival PFS as the main measure of treatment success. Participants are randomly assigned to one of three groups Arm A receives T-DXd and rilvegostomig intravenously every three weeks Arm B receives T-DXd and pembrolizumab intravenously every three weeks Arm C receives carboplatin and paclitaxel intravenously every three weeks for six cycles plus pembrolizumab every three weeks, followed by pembrolizumab maintenance every six weeks for up to 20 total cycles or about 24 months. Docetaxel may replace paclitaxel if needed. Treatment continues until disease progression or other reasons to stop treatment. During the study, participants undergo regular assessments including imaging and laboratory tests to monitor disease status and treatment effects. Researchers will evaluate progression-free survival until disease progression or death, overall survival, response rates, safety, pharmacokinetics, and patient-reported tolerability over periods ranging up to approximately 70 months. Safety monitoring continues for 90 days after the last dose. The study aims to better understand treatment options for this type of endometrial cancer.

Researchers are studying the PTSD-iMPACT questionnaire, a new tool designed to measure how post-traumatic stress symptoms affect daily functioning in children and adolescents aged 3 to 18 years. The study aims to validate this tool in both clinical and non-clinical populations in Switzerland and Germany. It addresses a need for a reliable, detailed measure of PTSD-related impairments across areas like family, school, friendships, hobbies, and media use. The study involves collecting data from trauma-exposed children, adolescents, and their caregivers through self-report and caregiver-report versions of the PTSD-iMPACT. Participants complete questionnaires at baseline and again two weeks later for test-retest reliability. Data collection occurs in clinical settings and schools, with some assessments completed online or via phonevideo calls. The study is conducted over 13 months and includes both German-speaking clinical populations and a non-clinical sample in Switzerland. Participants provide information on trauma exposure, PTSD symptoms, depression, anxiety, quality of life, and emotional regulation, among other measures. The study uses statistical analyses to assess the reliability and validity of the PTSD-iMPACT tool. Participants in clinical groups complete two assessments, while non-clinical participants complete one. Study involvement includes completing questionnaires online or in person with support provided as needed, ensuring confidentiality and voluntary participation throughout the study.

Researchers are evaluating elacestrant compared to standard endocrine therapy in patients with estrogen receptor-positive ER and human epidermal growth factor receptor 2-negative HER2- breast cancer who have a relapse detected by circulating tumor DNA ctDNA. This international, multi-center, randomized, open-label phase III trial focuses on patients without distant metastasis who show ctDNA positivity during screening. The study aims to assess whether elacestrant can improve outcomes over the current standard endocrine treatments. The study consists of two phases. First, during the ctDNA screening phase, patients on standard adjuvant endocrine therapy will have plasma samples collected every six months for about 5.7 years to detect ctDNA. Patients who test positive will undergo imaging to confirm no distant metastasis and then be randomized 11 to either continue their current endocrine therapy or receive elacestrant 400 mg orally once daily. Treatment duration depends on prior endocrine therapy length, lasting between 2 to 6 years. Intensive follow-up with ctDNA testing and imaging occurs for up to 3 years after randomization. Participants will be monitored closely with blood tests for ctDNA at weeks 4, 16, and every 16 weeks thereafter, along with yearly mammograms, bone scans, and CT scans every 16 weeks to detect metastases or recurrences. Safety, quality of life, and overall survival are assessed throughout, with follow-up continuing until three years after the last patient enrolls. The primary outcome measured is distant metastasis-free survival at 6.25 years after the first randomization.

Pelvic Pain Syndrome, specifically Urethral Pain Syndrome UPS, involves persistent or recurring urethral pain without infection or clear cause. This study aims to evaluate the effects of intraurethral and vaginal laser therapy on reducing urethral pressure pain in women with UPS. The research explores a new treatment option because existing therapies often show limited improvement, and laser therapy has shown promise in related gynecological conditions. Participants will receive intraurethral and vaginal laser treatment using the FotonaSmooth ErbiumYAG laser. This is a single-center, prospective pilot study designed to assess the safety and effectiveness of this laser therapy for UPS. The treatment process involves laser application directly to the urethral and vaginal areas, aiming to relieve symptoms and reduce pain. During the study, women will be monitored over several months with assessments including symptom improvement, reduction in tissue induration, pain levels during treatment, infection status, and satisfaction with treatment outcomes. These evaluations will occur at 3, 5, and 12 months after treatment. Participants will complete questionnaires and undergo clinical examinations to track progress and safety, with the total follow-up period extending up to 12 months.

Researchers are investigating genetic factors linked to Lichen Sclerosus, a skin condition affecting the genital area that can cause itching, pain, and difficulty with daily activities. This condition may be more common in white populations and can involve the skin outside the genital area in some cases. The study focuses on families with members affected by Lichen Sclerosus to understand underlying genetic causes and potentially discover new genes related to the disease. This observational study will collect genome sequencing data from families where some members have Lichen Sclerosus and others do not. By comparing genetic differences within these families, researchers aim to identify new genetic variants associated with the condition. The study is not interventional and does not involve treatments but focuses on genetic analysis over a five-year period. Participants will be family members affected by or related to someone with Lichen Sclerosus. Researchers will analyze genetic samples to identify potential disease-related genes. The main measure is the identification of novel genes linked to Lichen Sclerosus during the study. Participants will be followed for up to five years, contributing genetic data to help advance understanding of the disease and its hereditary factors.

Researchers are studying the use of vacuum-assisted biopsy VAB to better detect remaining breast cancer tissue after neoadjuvant chemotherapy NAC, which is a common initial treatment for breast cancer. NAC can lead to complete disappearance of the tumor in aggressive cancer types, but current imaging methods cannot reliably predict if any cancer remains. This study aims to compare the accuracy of tissue samples taken by VAB before surgery to the standard surgical tissue samples to see if VAB can serve as a less invasive way to check for residual cancer. Participants will undergo ultrasound- or mammography-guided VAB to sample tissue from the former tumor site after NAC and before standard breast surgery. The trial focuses on patients with certain breast cancer types who show a complete or near-complete response on imaging after chemotherapy. After the biopsy, participants will have breast conserving surgery or mastectomy, and both biopsy and surgical samples will be examined to evaluate the presence of residual cancer. During the study, patients will be monitored closely with imaging before VAB and surgery, and the tissue samples will be analyzed for residual disease. Researchers will measure how accurately VAB detects residual cancer compared to surgery by assessing sensitivity, specificity, and predictive values. Safety will be monitored from the biopsy until two weeks after surgery. The total time from registration to outcome measurement is up to six weeks.

Researchers are evaluating the addition of letrozole, an aromatase inhibitor, to the standard maintenance therapy in women diagnosed with estrogen-receptor ER positive epithelial ovarian cancer, including fallopian tube and primary peritoneal cancer. This study focuses on both low and high grade serous or endometrioid ovarian cancers at FIGO Stage II-IV, whose cancer has not progressed after primary surgery and platinum-based chemotherapy. The main goal is to determine if letrozole can increase progression-free survival compared to the current standard maintenance treatment with placebo. Participants are randomly assigned to receive either letrozole 2.5 mg daily or a placebo tablet once daily for up to five years or until toxicity symptoms or disease progression occur. This randomized, double-blinded, multicenter phase III trial involves 540 eligible women who will be monitored throughout the treatment period. The study also includes a sub-study focusing on low grade ovarian cancer LOGOS. Treatment adherence and tolerability will be assessed during regular visits. Participants will undergo health assessments including blood tests, physical and gynecological exams, and possibly imaging during routine follow-ups every 12 weeks for the first two years, then every 24 weeks for three additional years. Quality of life will be evaluated using specific questionnaires, and participants will wear an activity tracker for one week before visits. Researchers will measure progression-free survival as the primary outcome and also evaluate overall survival, time to next treatment, and quality-adjusted survival. Follow-up data will be collected for up to 12 years, including up to seven years after treatment ends to monitor long-term outcomes.