Dover

Researchers are conducting an observational registry to collect standardized data from adult patients receiving routine oncology care at participating cancer centers. The study aims to gather detailed information such as baseline patient characteristics, treatments administered, and outcomes to support research and improve clinical trial participation. Patient surveys are also included to enrich the data collected. No treatments or interventions are given as part of this registry. Instead, data is gathered from patients receiving their usual cancer care. This open-ended registry will continuously collect and analyze information over time to better understand treatment patterns, safety, and effectiveness. Participants will provide informed consent and contribute data through their regular care visits and surveys. Researchers will monitor treatment effectiveness mainly by tracking the time until treatment discontinuation. The registry will regularly analyze and present the data collected. Participation may last as long as the patient is receiving treatment and contributing data, with long-term follow-up possible.

Researchers are conducting an observational study to create precision external control groups using current and future data from patients with advanced or metastatic non-small cell lung cancer NSCLC. This study aims to evaluate different patient cohorts based on specific genetic mutations, PD-L1 status, and lines of therapy to better understand outcomes in this population. Participants are grouped into various cohorts depending on their treatment stage and genetic profile, including those starting first line therapy with immune checkpoint inhibitors ICI, patients with actionable EGFR or KRAS mutations, and those receiving second or later line therapies. The study collects information on patients receiving treatments such as ICI alone or in combination with chemotherapy, targeted therapies like osimertinib, and other physician-chosen regimens. During the study, participants medical data and treatment responses will be observed without intervention. Researchers will assess objective response rates, progression-free survival, overall survival, and time to next treatment across cohorts from September 2025 to April 2029. Participants will be followed over time to gather this information, with no additional treatments or procedures mandated by the study.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

Researchers are evaluating combinations of targeted drugs in people with advanced non-small cell lung cancer that has spread and shows specific changes in the EGFR and MET genes. This phase II Lung-MAP trial focuses on patients whose cancer has progressed after treatment with osimertinib and aims to compare the effectiveness of combining capmatinib, osimertinib, and ramucirumab. The study also investigates safety, response rates, and survival outcomes while collecting biological samples for further analysis. Participants are randomly assigned to one of two groups. One group receives capmatinib and osimertinib as oral medications plus ramucirumab given intravenously, while the other group receives only capmatinib and osimertinib orally. During the trial, patients undergo regular CT or MRI scans and blood sample collections to monitor their disease and treatment effects. The study includes detailed assessments of tumor responses and side effects over time. Throughout the trial, participants will have scans and blood tests at scheduled intervals to assess disease progression and treatment impact. Researchers will monitor progression-free survival as the main outcome, along with response duration and toxicity. Blood samples are also collected to study circulating tumor DNA. The study continues up to three years, with ongoing safety and efficacy evaluations. Participants must meet specific health criteria and provide informed consent before joining.

Researchers are studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

This research study focuses on participants of all ages diagnosed with Chronic Granulomatous Disease CGD, a condition characterized by defective NADPH oxidase activity or specific genetic mutations. The study aims to understand how common certain adenovirus antibodies and inflammatory cytokines are in this group by measuring their levels in the blood. This observational study is sponsored by Ensoma and seeks to provide insight into immune markers in CGD patients. Participants will provide blood samples to allow researchers to measure total adenoviral-specific antibody titers, adenoviral-specific neutralizing antibody titers, and circulating inflammatory cytokine levels. These measurements will be taken once during the study to characterize the prevalence of these immune markers in both adult and pediatric CGD patients. During the study, participants will have blood collected for analysis of the specified antibodies and cytokines. Researchers will evaluate the levels of these markers to better understand immune responses in CGD. The study requires only a single visit for sample collection and assessment. Safety and compliance will be monitored through the ability to complete the sample collection procedure, and the total participation time is limited to this one-day visit.

Researchers are building a prospective group of patients with locally advanced or metastatic non-small cell lung cancer NSCLC who have specific common EGFR mutations. This observational study collects standardized data at the start, during treatment, and when treatment ends. About 30% of patients who join before starting osimertinib treatment will have imaging done at regular intervals. Participants receive either osimertinib combined with chemotherapy or other treatments started after January 1, 2024, or receive osimertinib alone as the first treatment for metastatic NSCLC. The study tracks real-world outcomes such as how long patients live without the disease worsening, overall survival, and how long patients stay on treatment. During the study, patients will have their health and treatment progress monitored through data collection and imaging when applicable. Researchers will measure progression-free survival up to 100 months from starting first-line treatment, along with overall survival and time until treatment stops. The study is expected to continue until April 2029.

Researchers are collecting data on patients with Epidermal Growth Factor Receptor EGFR-mutant Non-Small Cell Lung Cancer NSCLC who are treated outside of a clinical trial with standard care using osimertinib alone or combined with chemotherapy. The goal is to better understand the safety and effectiveness of these treatments as they are used in routine clinical practice. This is an observational study recruiting about 250 patients per treatment group, including those receiving osimertinib alone or osimertinib plus chemotherapy. Patients are treated according to standard medical care as determined by their doctors. One group receives osimertinib by mouth once daily, while the other group receives osimertinib plus chemotherapy, with chemotherapy type chosen by the treating physician. Treatment dosing and administration follow standard guidelines. The study records planned treatments at registration and observes outcomes without altering the care given. Participants will have clinical and imaging assessments as part of their usual care, with data collected on their health and treatment progress. Researchers will measure real-world progression-free survival, overall survival, and time to stopping osimertinib for up to three years. The study follows participants over time to monitor how they respond to therapy and to gather safety information.

Researchers are evaluating patients with metastatic HER-2-positive breast cancer who are receiving trastuzumab-based therapy and are at risk of heart problems. The study includes two groups one large observational group taking beta blockers, ACE inhibitors, or ARBs alongside trastuzumab, and a smaller randomized group comparing the effects of carvedilol versus no treatment. The aim is to understand the occurrence of heart issues and whether carvedilol might help prevent cardiac side effects from chemotherapy. Participants are assigned to one of three arms based on their current medications. Patients not on beta blockers, ARBs, or ACE inhibitors are randomized to either receive carvedilol orally twice daily or no study intervention. Those already taking these heart medications enter an observational arm without additional treatment. Treatment and observation continue for up to 108 weeks unless disease progression or unacceptable side effects occur. Throughout the study, participants undergo heart function monitoring with echocardiograms every 12 weeks and provide blood samples for biomarker analysis. Researchers track the time to the first sign of heart dysfunction and any cardiac events, as well as adherence to medication and side effects. The study also collects data to develop models predicting heart risk and banks samples for future research. Participant involvement may last over two years with regular assessments to monitor safety and heart health.