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NCT07331506
Cancer continues to be one of the most significant public health issues worldwide. Thanks to early detection, the mortality rate of certain types of cancer has decreased significantly. However, the lack of accessible, low-cost, non-invasive, non-toxic, and easy-to-implement diagnostic methods results in late diagnoses, leading to 1 in every 6 people dying from cancer today. MicroRNAs (miRNAs) are small non-coding RNAs that regulate gene expression and are found both inside cells and in bodily fluids such as blood and urine. Several studies have demonstrated their role in human diseases, especially cancer, where tumors release miRNAs into the bloodstream that can be used as biomarkers for early detection. The research and development team at Oncoliq SAS identified a panel of miRNAs associated with breast cancer, with a detection performance of 82% sensitivity and 83% specificity, validated in exploratory and preliminary confirmatory studies. These results led to the filing of a patent based on liquid biopsy technology. The objective of this protocol is to establish a panel of miRNAs for the early detection of breast cancer using samples from breast cancer patients and a cancer-free control group. Validation of the miRNAs will be carried out through RT-qPCR. This stage constitutes the analytical validation of the biomarkers, with the goal of developing an algorithm capable of classifying individuals with and without breast cancer. In future stages, a pilot clinical trial is planned to evaluate test implementation and clinical validation.
NCT07298252
This study evaluates the diagnostic performance of Carebot AI MMG, an artificial intelligence (AI)-enabled medical device for evaluating mammograms. The software analyzes standard full-field digital mammography (FFDM) images and classifies each examination as having no suspicious finding ("Low Risk"), a probably benign mass ("Medium Risk"), or a suspicious malignant mass ("High Risk"). The study is retrospective and observational. It uses anonymized mammography examinations from four screening centers, without any additional imaging or contact with patients. Three experienced breast radiologists independently read the same set of cases, and their assessments are used as the human benchmark. A histopathology-based reference standard, supplemented by radiologist consensus and follow-up information for negative cases, is used to determine whether cancer is present. The main goal is to compare the AI system with human radiologists in terms of sensitivity and specificity for detecting breast cancer, and to assess whether the AI can achieve non-inferior performance at two predefined operating points: one favoring higher sensitivity and negative predictive value (rule-out) and one favoring higher specificity and positive predictive value (rule-in).
NCT07283107
Breast cancer is the leading cancer among women in Singapore, yet mammography screening rates remain critically low at 34.7%, despite the availability of a national program since 2002. This shortfall significantly limits the potential of screening to reduce mortality at a population level. While various behavioral interventions have been tested internationally to increase uptake, their applicability in the local context remains uncertain. Existing studies in Singapore are either outdated, small in scale, or not sufficiently targeted. In particular, two subgroups of women warrant closer examination due to the scarcity of data: (1) never-screeners: those who have never undergone a mammogram and (3) recent screeners: those who had a mammogram more than two years ago but have not scheduled their next one. These cohorts exhibit distinct behavioral and psychological barriers that prevent adherence to regular, guideline-recommended screening. E.g., key barriers for never- screeners include low perceived susceptibility to breast cancer, lack of awareness about the benefits of early detection, fear or anxiety about pain or receiving a cancer diagnosis, cultural or personal modesty concerns or lack of a physician's recommendation. In contrast, the repeat recent screeners often have a misconception that a single normal result is sufficient, negative experiences during prior screenings (e.g., false positives, pain), absence of reminder systems and competing life priorities and lack of time. Among these, engaging never-screeners is particularly challenging, as they may not perceive screening as personally relevant or necessary, and many have successfully avoided the healthcare system for years. Yet, failure to engage these groups; poses a significant public health concern, as it undermines the effectiveness of population-level cancer control strategies. The PROMPT study is designed to fill this critical gap by systematically evaluating multiple low-cost, scalable outreach strategies in two parallel randomized trials. Its findings will provide robust, local evidence to inform policy and improve engagement of these hard-to-reach populations.
NCT07080515
The goal of this observational study is to engage with multilevel stakeholders to collaboratively and to systematically develop a suite of strategies for implementing breast cancer screening using clinical breast examination (CBE) in the primary health centers of Abuja, Nigeria. The main questions it aims to answer are: What barriers and facilitators exist to conducting screening CBE in Abuja's primary care setting and what implementation strategies would support CBE in primary care clinics? Participants will: * Allow observation of study clinic workflows * Participate in interviews and focus group discussions regarding screening CBE implementation
NCT07114679
The goal of this pilot clinical trial is to demonstrate supplemental screening MBI (molecular breast imaging) in women with dense breasts. The main questions it aims to answer are: * Does screening MBI find more cancer than screening DBT (3D mammography, digital breast tomosynthesis? * Does screening MBI result in more call-backs for biopsy than DBT? * How well does MBI-guided biopsy conform with pathology reports? Researchers will compare screening MBI to screening DBT to see if MBI is more sensitive to detecting cancer in women with dense breasts. Participants will * Receive both screening DBT and screening MBI * Receive either DBT-guided or MBI-guided biopsy (randomly assigned), if required by the screening images
NCT07056686
The goal of this observational study is to evaluate breast cancer awareness, screening practices, and barriers to early detection among women in the middle region of Syria. The main questions it aims to answer are: 1. What is the level of awareness among women in this region regarding breast cancer symptoms and risk factors. 2. How do women practice breast self-examination and professional screenings. 3. What barriers prevent women from seeking early detection and treatment? Participants will complete a survey assessing their knowledge, behaviors, and challenges related to breast cancer screening. The findings will inform public health interventions to improve awareness and early detection practices.
NCT06733155
Breast cancer is the most common cancer among women in Singapore, with more than 70 women out of every 100,000 being diagnosed each year. Early detection through regular mammograms can significantly reduce deaths from breast cancer. Although Singapore has had a national breast cancer screening program (now part of the Screen for Life initiative) for over 20 years, and the government offers substantial subsidies to make screening more affordable, participation remains low at only 30-40%. This low uptake is due to factors like fear, lack of awareness, cultural beliefs, and a perceived low risk of breast cancer. To be effective on a large scale, at least 70% of women need to participate in regular mammography screenings. While researchers in Singapore and Asia have studied the reasons behind low screening rates, there is still a lack of large-scale studies that test different strategies to increase mammography participation in these regions. This trial will recruit 12,000 women aged 50-69 who have not undergone a mammogram in the past two years. 9000 women will be randomized into five intervention arms. The interventions include: direct mail reminder (Arm 1, control, n=3000), financial incentive (Arm 2, n=1500), lottery incentive (Arm 3, n=1500), health messaging from an influential figure (Arm 4, n=1500), and personal health concierge for appointment scheduling (Arm 5, n=1500). Another 3000 women will be placed in a non-interventional arm (NI arm) for observational analysis, that receives no reminders at all. A post-intervention telephone survey will assess intervention effectiveness. The primary outcome is mammogram uptake across intervention arms with Arm 1 as a reference. Secondary outcome will be to compare Arm 1 with NI arm. Subgroup analyses will evaluate differences in uptake by sociodemographic factors, such as ethnicity and socioeconomic status. A cost-effectiveness analysis will assess the financial viability of each intervention. This is the first large-scale study in Singapore and Asia to compare multiple interventions to boost mammography uptake. Findings will provide evidence-based strategies to improve breast cancer screening participation, potentially reducing breast cancer mortality and informing future public health policy.
NCT06836089
his clinical trial aims to evaluate the efficacy and diagnostic accuracy of Diffusion Weighted Imaging (DWI) in breast MRI for women with dense breast tissue. DWI is investigated as an adjunctive method to improve early tumor detection in women with dense breasts, a group at high risk for delayed diagnosis due to limited visibility in mammography. Study Purpose: To assess the utility of Diffusion Weighted Imaging (DWI) in improving diagnostic accuracy for patients with dense breasts.
NCT04260620
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma. This reader study will include up to 32 radiologist readers and a sample of 140 breast screening cases that were selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839) Arm 1 Phase B. The reader study image case set will be enriched with cancer cases.