Clinical Research Directory

The Phase I Study of SIG001 Antibody on Cancer Therapy.

The goal of this clinical trial is to learn the safty characteristics of SIG001 Mab in cancer patients; It will also determine the Recommended Phase II dose of SIG001 Mab on cancer treatment, and pharmacological characteristics of SIG001. The main questions it aims to answer are: What is the safety and tolerability of SIG001 in patients with advanced solid tumors ? What is the Recommended Phase II dose of SIG001? What is the PK/PD characteristics of SIG001 in cancer patients? What is the antitumor activity of SIG001 in cancer patients? What is the immunogenicity of SIG001 in cancer patients? What is the relationship between the exposure/dose of SIG001 and its safety as well as clinical efficacy? What is the expression levels of potential biomarkers (such as SIG), if applicable, and analyze their correlation with drug exposure, efficacy, and safety? What is event-related endpoints such as the Duration of Response and Progression-Free Survival in patients treated with SIG001? This will be a single-armed study. Participants will: Intravenously Inject SIG001 every two weeks, for 4 weeks Visit the clinic on the 14th day, 30th day, and 90th day afer the last injection. Then visit the clinic for every 12 weeks.

Plyometric Strength-Endurance Exercise in Breast Cancer

This study aims to compare an adapted plyometric strength-endurance exercise program with conventional strength training in women who are breast cancer survivors or currently undergoing treatment and who participate in provincial support associations. The goal is to determine whether a targeted plyometric intervention can provide additional benefits in physical and mental health outcomes. Using a cluster-randomized clinical trial design, the study will assess indicators such as functional capacity, muscle strength, fatigue levels, symptoms related to lymphedema, and overall quality of life. The findings are expected to contribute to a better understanding of how structured exercise programs can support recovery, physical function, and well-being in women affected by breast cancer.

Using Virtual Reality During PICC and PICC-PORT Placement in Cancer Patients

Virtual reality (VR) has increasingly been explored in medical settings as a non-pharmacological intervention for the management of pain and anxiety associated with invasive procedures. By providing immersive and interactive environments, VR is thought to modulate both sensory and emotional components of pain through mechanisms involving focused attention, cognitive engagement, and altered perception, which share similarities with hypnosis-based approaches. Evidence from previous studies, initially conducted mainly in paediatric populations and more recently extended to adults, suggests that VR may effectively reduce procedural anxiety and pain without increasing procedural duration or clinical workload. Oncology patients undergoing the placement of vascular access devices, such as peripherally inserted central catheters (PICC) and PICC-PORTs, frequently experience procedural distress, including anxiety and discomfort, related to the invasive nature of the intervention. Procedural anxiety may negatively influence patient experience, cooperation, and overall tolerance of the procedure, potentially increasing the need for pharmacological anxiolytic or analgesic support. Identifying effective, safe, and easily applicable non-pharmacological strategies to reduce distress during these procedures represents a relevant clinical goal in oncology care. The present study aims to evaluate the effectiveness of virtual reality delivered via a head-mounted display in reducing patient-reported anxiety and pain in adult oncology patients undergoing PICC or PICC-PORT insertion. This study is designed as a prospective, interventional, randomised controlled trial with a 1:1 allocation ratio using a random number generator within REDCap. A total of 120 patients will be enrolled at a single centre, the Istituto Oncologico Veneto (IRCCS), and randomly assigned to one of two study arms. Participants allocated to the intervention arm will receive VR in addition to the standard of care (VR + SOC) throughout the vascular access placement procedure, while participants in the control arm will undergo the standard procedure alone (SOC). The VR intervention will be delivered using HypnoVR, a software-based medical device classified as Class I, non-sterile, and compliant with Regulation (EU) 2017/745 on Medical Devices. The intervention will be administered via a head-mounted display with audiovisual content designed to promote relaxation, focused attention, and emotional regulation during the procedure. The primary outcome measure is the reduction of anxiety levels at the end of the procedure, assessed using the validated Visual Analogue Scale for Anxiety (VAS-A). Secondary outcomes include patient-reported pain, qualitative assessment of procedural comfort, and perceived ease of procedural management as reported by healthcare staff. Data collection will include both quantitative and qualitative measures within a mixed-methods framework. Quantitative data will be analysed using descriptive and inferential statistical methods to assess differences between study groups, while qualitative data derived from semi-structured interviews will be analysed using the Van Kaam phenomenological method to explore patients' lived experiences. The study aims to provide evidence on the role of virtual reality as a supportive, non-pharmacological option for anxiety and pain management during vascular access placement in oncology patients.

Community-Based Exercise Oncology: Real-World Evidence of High Adherence, Improved Quality of Life and Cost-Effectiveness Across the Cancer Continuum

This prospective observational cohort study evaluates a community-based supervised exercise oncology program delivered in real-world settings in Madrid, Spain. The program is designed for adults with a cancer diagnosis across the cancer continuum, including survivors, patients undergoing active treatment, individuals receiving hormonotherapy, and patients with metastatic disease. Participants take part in a structured multimodal exercise program combining aerobic, resistance, and functional training, delivered in supervised group-based sessions either in person or through synchronous online formats. The primary aims of the study are to assess program adherence, health-related quality of life, fatigue, and cost-effectiveness, expressed as quality-adjusted life years (QALYs). Secondary outcomes include cardiorespiratory fitness, muscular strength, functional capacity, physical activity levels, body composition, and psychological well-being. Assessments are conducted at baseline and every four months over a 12-month follow-up period. This study provides real-world evidence on the feasibility, clinical impact, and economic value of community-based exercise oncology programs across different stages of the cancer trajectory.

xDRIVE for Florida-based Cancer Patients

Through this study funded by the Florida Cancer Innovation Fund, First Ascent will demonstrate state-wide feasibility of providing xDRIVE Functional Precision Medicine + Artificial Intelligence platform by assessing patient clinical benefit and health economics impacts. As this is a feasibility study, results will be returned to the physician and the physician may use the data to inform the next line of treatment. The investigator will run a prospective single-arm feasibility study providing the xDRIVE FPM AI platform to n = 210+ cancer patients throughout the state of Florida, especially those from underserved populations (pediatric patients and patients in Black, Brown, Hispanic, and rural communities).