Manchester

Researchers are conducting a multicenter observational patient registry to collect information on outcomes from patients undergoing cryoablation of the intercostal nerves, also known as cryoanalgesia, for managing post-operative pain after cardiothoracic surgery. This registry includes both retrospective and prospective data to better understand the effectiveness and safety of this pain management approach over time. The study involves the use of the AtriCure Cryo Nerve Block Device Family to create cryoanalgesia for post-operative pain control. Patients who have undergone or are scheduled to undergo cryoablation using these devices, or similar patients treated without cryoablation, are included in the registry. The study captures data from the time of enrollment up to five years following the initial procedure. Participants contribute data through their clinical treatment records as part of this registry. The research team monitors the efficacy and safety of the cryo nerve block method for pain management over a five-year period from the date of the index procedure. This long-term follow-up helps researchers understand both the benefits and any risks associated with this treatment. The overall participation duration varies depending on when the patient was treated and enrolled.

Researchers are evaluating the long-term safety of lonapegsomatropin in children with growth hormone deficiency who are already being treated with this medication. This study is observational and aims to gather real-world safety data over time after the drug has been authorized for use. The focus is on monitoring potential risks such as the development of tumors and type 2 diabetes over a period of five years. Participants receive lonapegsomatropin, administered once weekly by subcutaneous injection as part of their usual care. The study does not involve additional interventions but observes patients who are already treated with this therapy. The observational period extends for at least five years to collect safety data and compare it with historical information from previous studies. During the study, researchers will monitor for the occurrence of benign and malignant tumors, type 2 diabetes, and other adverse events affecting the kidneys, liver, immune system, and nervous system. They will also track medication errors and measure the response of Insulin-like Growth Factor-1 (IGF-1) to treatment. Participants are followed up regularly to collect this information, with the study lasting until March 2033.

Researchers are evaluating the combination of Navlimetostat (BMS-986504), pembrolizumab, and chemotherapy compared to placebo plus pembrolizumab and chemotherapy in participants with first-line metastatic non-small cell lung cancer (NSCLC) who have a homozygous MTAP deletion. This randomized phase 2/3 study focuses on metastatic NSCLC participants with no prior systemic treatment for metastatic disease and aims to assess clinical benefits of adding Navlimetostat to standard treatments. Participants are assigned to one of several study groups receiving either the combination of BMS-986504, pembrolizumab, and chemotherapy drugs (including cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel) or placebo with pembrolizumab and chemotherapy. Each drug is given at specified doses on specified days. The study uses a quadruple-blind method to compare these treatments over time. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, evaluations of progression-free survival and overall survival up to five years, and monitoring for treatment-related side effects. Researchers will also track the duration and timing of tumor responses and collect safety data up to 90 days after last treatment. The total participation duration may extend up to five years for long-term outcome assessments.

This research aims to gather long-term evidence on the safety and effectiveness of SKYTROFA (lonapegsomatropin) in patients with growth hormone deficiency who are receiving routine clinical care. The study focuses on understanding how patients respond to this treatment over time without altering their usual medical management. It is a non-interventional observational study conducted across multiple centers in the USA. Patients will continue their regular treatment with SKYTROFA as managed by their healthcare providers, with no additional visits, examinations, or tests required beyond standard clinical care. The study will collect data from clinical outcome assessments (COAs) to evaluate treatment results and safety over a period of five years. No experimental interventions or placebos are involved. Participants will be monitored through their routine clinical visits, with researchers reviewing their health status and treatment effectiveness using standard assessments. The primary outcomes include measuring safety and treatment effectiveness over five years, along with evaluating clinical outcomes through COAs. This approach allows for natural observation of patient experiences without extra procedures or disruptions to their care.

Researchers are investigating treatments for patients with stage IV or recurring non-small cell lung cancer who have previously received platinum chemotherapy and immunotherapy. This phase II/III trial compares the effects of adding cemiplimab, an immune system-stimulating monoclonal antibody, to the usual combination of docetaxel and ramucirumab. The goal is to see if adding cemiplimab helps the immune system better attack tumor cells and improves survival outcomes. Participants are randomly assigned to one of two groups. One group receives docetaxel and ramucirumab along with dexamethasone, while the other group receives these same treatments plus cemiplimab. Treatments are given in cycles every 21 days, with infusions lasting from 30 minutes to an hour depending on the drug. Patients undergo regular blood sample collections and imaging scans such as CT or MRI throughout the study. During the trial, participants are monitored for overall survival, disease progression, tumor response, and side effects. After completing treatment, follow-up visits occur every 3 to 6 months for up to 3 years. Blood tests and imaging help assess treatment effects and safety. Researchers also collect and store blood and tissue samples to support future studies.

Researchers are evaluating camizestrant, a new oral drug, compared to standard adjuvant endocrine therapies for patients with early breast cancer that is estrogen receptor positive and HER2 negative. This trial focuses on patients at intermediate-high or high risk for the cancer returning who have completed local treatments like surgery, with or without chemotherapy. The study is a Phase III open-label trial sponsored by AstraZeneca, aiming to see if camizestrant improves invasive breast cancer-free survival over a planned treatment duration of seven years. Participants will be randomly assigned to one of two treatment groups: one receiving standard endocrine therapy chosen by the doctor (including aromatase inhibitors such as exemestane, letrozole, or anastrozole, or tamoxifen) with or without abemaciclib, and the other receiving camizestrant with or without abemaciclib. Treatments are taken orally, and both groups are followed for up to 10 years from the last patient's randomization to monitor outcomes and safety. During the study, participants will have regular assessments to monitor invasive breast cancer-free survival, overall survival, and other outcomes like distant relapse-free survival and quality of life. Safety evaluations include tracking side effects using established criteria and patient-reported measures. Pharmacokinetics of camizestrant will be studied for six months, with adverse events monitored up to 28 days after the last treatment dose. The total involvement can last up to 14 years including treatment and follow-up periods.

Researchers are studying the safety and effectiveness of Cardiac Contractility Modulation (CCM) therapy in people with heart failure who have a left ventricular ejection fraction (LVEF) between 40% and 70%. This clinical trial includes two parts with separate scientific goals: Part I focuses on functional capacity and health status, while Part II evaluates clinical outcomes. The study is randomized, quadruple-blind, and sham-controlled, involving subjects from about 225 sites worldwide. Participants will have an OPTIMIZER Smart Mini System implanted that delivers CCM therapy. They will be randomly assigned in a 2:1 ratio to either have CCM therapy turned ON continuously or to a sham group with CCM therapy turned OFF for the first 18 months. After 18 months, the sham group will also have CCM therapy turned ON. CCM therapy consists of seven one-hour sessions distributed evenly over each 24-hour period. The study includes follow-up through both parts, lasting up to several years. During the study, participants will undergo screening and baseline testing before implantation. Researchers will measure changes in walking distance over six minutes and health status by the Kansas City Cardiomyopathy Questionnaire after six months. Safety will be assessed by tracking device- or procedure-related complications for 12 months. Clinical outcomes including mortality, morbidity, and health status will be reviewed after 18 months. Participants will be monitored regularly for these outcomes throughout the study duration.

Researchers are evaluating how newly diagnosed Stage I HER2-positive invasive breast cancer responds to one of two different combinations of HER2-directed therapies after surgery. The study compares the effects and side effects of trastuzumab-emtansine (T-DM1) followed by subcutaneous trastuzumab versus paclitaxel combined with subcutaneous trastuzumab. This phase II randomized trial also aims to understand the long-term benefits and disease-free survival for participants treated with these therapies. Participants are randomly assigned to one of two treatment groups. The first group receives intravenous T-DM1 every three weeks for six cycles, followed by subcutaneous trastuzumab every three weeks for eleven cycles. The second group receives weekly intravenous paclitaxel for twelve weeks alongside subcutaneous trastuzumab every three weeks for the first four doses, then continues with trastuzumab alone every three weeks for seventeen cycles. Treatment lasts about one year in total. During the study, participants undergo screening and regular evaluations including laboratory tests and follow-up visits. Researchers monitor the occurrence of clinically relevant toxicities during the first 18 weeks and track disease-free survival for up to 72 months. Additional assessments include quality of life, symptoms related to therapy, side effects, cardiac function, gene profiling, and overall survival. Participants will be followed for five years after completing treatment to assess long-term outcomes.

Researchers are collecting blood and tissue samples from patients with and without cancer to evaluate tests that might help detect cancer early. This observational study aims to create a blinded reference set of blood samples from both cancer and non-cancer patients to validate blood-based multi-cancer early detection tests. The study also assesses test performance at the time of initial cancer diagnosis by tumor type and clinical stage. Participants complete a questionnaire at the start of the study and provide blood samples at registration and again 12 months later. Patients diagnosed with cancer may also provide tissue samples at these same time points. The study collects samples to support the development and validation of early detection assays, with no treatment interventions involved. During the study, participants fill out questionnaires and provide blood and possibly tissue samples. Researchers follow up with participants one year after study completion. The main outcome is the creation of a blinded reference set of blood samples to test early cancer detection methods. The study monitors test performance based on cancer type and stage, with all evaluations completed within one year of enrollment.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer based on the presence or absence of circulating tumor DNA (ctDNA) after surgery. This Phase II/III trial focuses on patients with Stage IIB, IIC, or Stage III colon adenocarcinoma who have undergone tumor removal. The study aims to use ctDNA status to better predict the risk of cancer recurrence and guide decisions about adjuvant chemotherapy. Participants will be assigned to different treatment groups based on their ctDNA status after surgery. Patients without detectable ctDNA will undergo serial ctDNA monitoring without immediate treatment or receive standard chemotherapy regimens such as mFOLFOX6 or CAPOX for varying durations. Patients with detectable ctDNA will receive either standard chemotherapy or intensified regimens like mFOLFIRINOX. Treatments involve intravenous and oral chemotherapy drugs given over several cycles spanning weeks to months. Throughout the study, participants will have ctDNA testing using the Signatera test and be monitored for disease-free survival, overall survival, and recurrence up to five years after randomization. Safety and treatment adherence will also be tracked. Regular imaging and laboratory tests will assess disease status and organ function. The study may include re-randomization for patients who develop positive ctDNA during monitoring. Total involvement may last several years with follow-up for long-term outcomes.