Clinical Research Directory

Validation of the Oncoliq Test for the Early Detection of Breast Cancer.

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.

The Study Will Enroll Females Who Are Coming in for Their Annual Mammogram Screening and Who Are Schedule for a Biopsy to Provide a Breath Sample Via a Mask to Evaluate if Breast Cancer Can be Detected.

Primary Objective: 1\. To evaluate the sensitivity of the SpotitEarly test for breast cancer detection in women Secondary Objectives: 1. To evaluate the performance of the SpotitEarly in various subgroups. 2. To evaluate the performance of the SpotitEarly test in detecting early-stage cancer (stages 0-2). 3. To assess whether the performance of the SpotitEarly test is affected by psychological impacts (e.g. anxiety) related to the biopsy procedure. Exploratory Objective: 1\. To evaluate the test-retest reliability of SpotitEarly's test.

Developing Screening Clinical Breast Examination Implementation Strategies in Nigeria

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

UCF MammoChat: Image Repository

This study aims to develop AI models to better read diagnostic mammograms for various populations and types of breast cancer, using the images that participants donate and their responses from study questionnaire to improve patient outcomes. This study also aims to provide mammography images to participants.

AI-Based Self-Supervised Learning Model Using Non-Contrast Breast MRI for Early Screening and Clinical Utility Evaluation

Breast cancer is the most common malignant disease among women worldwide, with rising incidence and younger age at onset in China. Early detection is critical for improving survival, yet current screening methods such as mammography and ultrasound show limited sensitivity in Chinese women, particularly those with dense breast tissue. Contrast-enhanced MRI offers higher diagnostic performance but its use is limited by high costs, safety concerns with gadolinium-based contrast agents, and limited accessibility. This investigator-initiated trial aims to evaluate the clinical application of non-contrast multiparametric MRI, combined with advanced artificial intelligence algorithms, for the early detection and diagnosis of breast cancer. The study will collect MRI imaging data from multiple centers and integrate radiomic features across T2-weighted imaging, diffusion-weighted imaging, and apparent diffusion coefficient maps. A deep learning-based model will be developed and validated to improve lesion detection, differential diagnosis, and risk stratification. The ultimate goal of this project is to establish a safe, accurate, and scalable breast cancer screening pathway suitable for Chinese women. By reducing dependence on invasive procedures and contrast agents, and by leveraging AI for standardization and efficiency, this approach may significantly improve early detection rates and contribute to better patient outcomes.

Molecular Breast Imaging (MBI)-Guided Biopsy

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

Early Detection of Breast Cancer Among Syrian Women

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.

Second-Look Ultrasound Post Contrast-Enhanced Mammography for Additional Lesions Characterization

This study investigates the utility of second-look ultrasound (US) following contrast-enhanced mammography (CEM) to characterize additional lesions detected during routine breast imaging.

DWI Breast MRI in Dense Breast: A Clinical Trial to Assess the Efficacy and Diagnostic Accuracy of Diffusion Weighted Imaging in Dense Breast Tissue

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.