Clinical Research Directory

TRTRM (ACTTOP) -Guided Dosing Strategy in Older Patients With Cancer

Older adults receiving systemic cancer treatments are at increased risk of developing severe treatment-related toxicities (TRT). Existing prediction tools such as CARG and CRASH have limited applicability in Chinese populations and do not fully address toxicities associated with newer therapies, including immunotherapy and targeted agents. The Treatment-related Toxicity Risk Model (TRTRM) was recently developed and validated in Hong Kong using data from 700 older cancer patients and has demonstrated better predictive accuracy and clinical relevance compared with existing tools. This multi-center, open-label, randomized controlled trial aims to evaluate the clinical utility of the TRTRM by guiding treatment dose intensity and monitoring strategies. Participants aged 65 years or older who are starting a new systemic anti-cancer treatment will be randomized in a 1:1 ratio to receive either usual care or TRTRM-informed care. In the intervention arm, patients identified as having intermediate or high risk of toxicity will receive a "start-low, go-slow" dosing strategy with close monitoring, while low-risk patients will receive standard dosing. The primary outcome is the incidence of grade 3 or higher treatment-related toxicities within the first two months of treatment initiation. Secondary outcomes include emergency visits, unplanned hospitalizations, premature treatment termination, early mortality, quality of life, and overall survival.

WellSpan-THRIVE Cancer QOL Study

Cancer affects millions of people worldwide and can significantly impact not only survival, but also day-to-day quality of life. Treatments such as surgery, chemotherapy, and radiation can cause side effects like fatigue, pain, and neuropathy, which may affect physical function, emotional well-being, and social relationships. While many studies have examined factors that influence quality of life; such as age, type and stage of cancer, and treatment-related symptoms; there is still a need for tools that more fully reflect patients' lived experiences. This study aims to develop and implement a patient-centered quality of life (QOL) survey designed specifically for individuals with cancer. By directly involving patients in sharing what matters most to them, the survey seeks to provide a more complete and accurate understanding of how cancer and its treatment affect daily life. The results will help patients, families, and healthcare providers better identify needs, guide supportive care, and improve overall well-being throughout the cancer journey.

Comparative Effectiveness of Verbal Instruction Versus Simulation Video Education Among Cancer Patients Undergoing Radiation Therapy

The goal of this Randomized Controlled Trial is to compare the effectiveness of radiotherapy-specific, physician-led educational videos introduced before the initial Radiation Therapy consultation . The primary objective is to assess the impact on patient-reported knowledge of RT, with secondary objectives including assessment of patient-reported anxiety and satisfaction with the educational process. Patients will be randomly assigned to two groups. 1. Video Group - Patients will receive a WhatsApp message containing the educational video prior to their consultation. 2. Verbal Instruction Group - Patients will receive standard verbal education from a radiation oncologist during their consultation. The participants will fill Pre and post intervention questionnaire forms

A Phase 1 Study of JMT108 in Participants With Advanced Solid Tumors

The goal of this clinical trial is to test JMT108, a type of drug called a bispecific antibody in adult patients with locally advanced or metastatic solid tumors. The main questions it aims to answer are: * To assess the safety and tolerability of JMT108 at increasing doses and determine the dose and schedule to be used in the second part of the study (Phase 1a) * To assess effectiveness of JMT108 in participants with locally advanced or metastatic tumors (Phase 1b) * To evaluate how quickly JMT108 is metabolized by the body (pharmacokinetics or PK) * To evaluate if antibodies to the study drug develop (immunogenicity) * To evaluate preliminary efficacy to the drug * To explore the pharmacodynamic (PD) characteristics of JMT108 * To explore the correlation between biomarker levels and preliminary efficacy Participants will: * Provide written informed consent * Undergo screening tests to ensure they are eligible for study treatment * Attend all required study visits and receive JMT108 by intravenous injection every 2 weeks until the study doctor determines study treatment should be stopped, based on how well a participant is doing on treatment * Be followed for progression every 3 months for up to 2 years

Immune Adverse Events Registry in Onco-Hematologic Patients Treated With Immunotherapy

Immunotherapy is a therapeutic strategy aimed at inducing the immune system to identify and combat cancer cells and, alongside the evident clinical success observed in many patients, a specific toxicity profile has emerged, associated with the modulation of the immune system achieved with this type of drugs, known as Immune-Related Adverse Events (irAEs). irAEs encompass a highly heterogeneous spectrum of autoimmune manifestations that can potentially involve any organ or system, occurring in \~ 80% of patients treated with anti-CTLA-4 agents and in \~ 60-70% of patients treated with PD-1/PD-L1 inhibitors. However, severe (grade 3-4) irAEs affect only \~ 15% of patients treated with CTLA-4 inhibitors and \~ 5-10% of patients receiving anti-PD-1/PD-L1 agents, with a mortality rate ranging from 0.36% to 1.23%. The main characteristic of irAEs is their unpredictability in terms of time of onset, severity and responsiveness to immunosuppressive agents. Therefore, the management of irAEs often requires clever interpretation of clinical symptoms, proper choice of laboratory tests and imaging tools, and ability to perform differential diagnosis with other condition associated to tumour itself or to unrelated concomitant events (i.e., infections). Although international societies (i.e.; ESMO) have provided detailed guidelines for the management of irAEs or algorithms for the administration of ICI in patients with pre-existing autoimmune disease, they are sometimes difficult to be applied to certain complex situations. Furthermore, given the scarcity of data from clinical trials, some of these recommendations are mainly based on highly heterogeneous patients' population included in relatively small real world studies. Therefore, recommendations should always be adapted to specific clinical conditions and challenges. Studies investigating these aspects have particularly focused on the autoimmune antibody response, correlating its positivity in various ways with clinical outcomes. However, the results across different studies are not consistent. Moreover, additional prospective data are needed to confirm which information can guide the management of irAEs in order to optimize therapy and improve prognosis without negatively impacting oncological outcomes. The adoption of a therapeutic strategy tailored to irAEs is essential for improving both the immunological and oncological prognosis of patients affected by this group of manifestations. A prospective and cross-sectional observational approach to study irAEs is fundamental to the development of such therapeutic innovation. This study approach must be based not only on monitoring patients who have already developed irAEs but also on profiling patients even before the development of irAEs to determine which factors are associated with this group of pathologies and the different characteristics they may assume once they arise. The protocol will be based on the retrospective acquisition of data concerning the clinical history of the patients involved, from birth until recruitment into the study, and the prospective recording of information regarding the disease characteristics (both immuno-rheumatological and oncological) and the subsequent evolution of the clinical picture. Study procedures will take place during visits scheduled as part of routine clinical practice and will include the collection of data-clinical, laboratory, and imaging-related to the patient's oncological disease and irAEs, the characteristics of the diagnostic-therapeutic procedures performed, and the subsequent immuno-oncological outcomes. All patients scheduled to begin immunotherapy treatment will be enrolled in the study, as well as those who have developed irAEs without being enrolled prior to the onset of immuno-mediated manifestations. Enrolled patients who do not develop irAEs will be considered as the control group, providing essential information on risk profiling for the development of irAEs.

N-Acetylcysteine Roles in Preserving Renal Function Measured by Urinary KIM-1 (Kidney Injury Molecule-1) and Serum Creatinine on Cancer Patients With Cisplatin Based Chemotherapy: A Randomized Placebo-Controlled Trial

The goal of this clinical trial is to learn if N-Acetylcysteine drug works to protect kidney function in adults patient with cancer. Kidney function will be measured by laboratory parameter using urine sample (KIM-1 urine) and blood sample (serum creatinine). The main questions it aims to answer are: 1. Does N-Acetylcysteine lower the level of KIM-1 (Kidney Injury Molecule) in patients urine indicating kidney function protection? 2. Does N-Acetylcysteine lower the level of creatinine in patients blood indicating kidney function protection? Participants will: 1. Had their blood and urine sample taken before taking the drugs (N-Acetylcysteine or placebo) 2. Underwent cisplatin based chemotherapy 3. Taken placebo or N-Acetylcysteine for seven days (1 day before chemotherapy, on the chemotherapy day, and 5 days after chemotherapy) 4. Had their blood and urine sample taken twice after taking the drugs (1 week and 3 weeks after chemotherapy) 5. Had their symptoms monitor during and after taking the drugs. Every possible side effect, hospitalization, or death will be recorded.

Cardiovascular Risk in Children With Chronic Conditions Study

Children living with chronic health conditions face a higher risk of developing cardiovascular diseases than their peers, largely due to the accelerated aging of the heart and blood vessels. Although experts recognize this elevated risk and recommend close monitoring and early intervention, the underlying mechanisms driving this phenomenon remain poorly understood. At present, no effective interventions specifically target its root causes. Recent research shows that both large blood vessels (such as the carotid artery) and small vessels (such as those in the retina) can display early signs of damage decades before clinically apparent heart or vascular disease emerges. This accelerated vascular aging can result from multiple factors - including disease-related processes such as persistent inflammation and metabolic disturbances, treatment-related effects such as chemotherapy or long-term steroid use, and lifestyle changes associated with chronic illness, such as reduced physical activity and altered eating habits. However, it is still unclear how these factors influence the development and progression of vascular changes in children as they grow. Importantly, these changes can be monitored through non-invasive methods, offering a unique opportunity to study at-risk patients many years before overt cardiovascular disease develops. Identifying these early changes may enable us to detect and track individuals at heightened risk well in advance of clinical disease. This study aims to deepen our understanding of the causes of increased cardiovascular risk in children with chronic conditions and to lay the groundwork for earlier, more targeted prevention strategies.

Salutare One Referral Software Impact on Multi-Disciplinary Team (MDT) Meetings Effectiveness and Safety

Multi-Disciplinary Team (MDT) meetings are crucial for planning patient care in the National Health Service (NHS), but they can be time-consuming and sometimes lack complete patient information. This can lead to delays in treatment decisions, potentially incomplete care plans, or the need to repeatedly discuss the same patient cases. This study aims to test a new software called Salutare One Referral. One Referral is designed to make these meetings more efficient and effective. We want to see if this software can help healthcare staff prepare MDT referral information more easily and facilitate a more informed MDT discussion, which could lead to better patient care. If successful, this could help improve how MDTs operate across the NHS.