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Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.

Researchers are evaluating whether breast conservation surgery combined with endocrine therapy can achieve a similar rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery followed by breast radiation and endocrine therapy in patients with Stage I, hormone sensitive, HER2-negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial builds on the established role of radiation after lumpectomy, aiming to identify if radiation can be safely omitted in certain low-risk patients to reduce treatment burden and side effects. Participants receive either breast radiation plus endocrine therapy or endocrine therapy alone. Radiation therapy involves external beam radiation to the whole breast with or without a boost, partial breast irradiation, or accelerated partial breast irradiation, starting within 12 weeks after the last breast surgery. Endocrine therapy is given for a minimum of 5 years, with the specific drug choice and schedule determined by the treating physician. Endocrine therapy may begin before, during, or after radiation therapy, depending on the treatment group. Throughout the study, participants undergo regular assessments including imaging such as mammograms or MRI within six months before enrollment, and clinical evaluations to monitor tumor recurrence. The main outcome measured is the time to invasive or non-invasive ipsilateral breast tumor recurrence over five years. Safety, adherence to therapy, and recovery from surgery are also monitored. The total participation period includes at least five years to evaluate long-term recurrence rates.

Misophonia is a condition where specific sounds cause strong emotional reactions, impacting daily life and quality of life. Researchers are evaluating a fully automated online Acceptance and Commitment Therapy (ACT) program designed to help adults with misophonia. This study aims to compare the effectiveness and acceptability of the online intervention against a waitlist control group in adults who meet clinical criteria for misophonia. Participants will be randomly assigned to either the intervention group or the waitlist control group. Those in the intervention group will complete an 8-module digital ACT program focusing on acceptance, cognitive defusion, present moment awareness, values clarification, and practical adaptations. The program is based on a previously developed ACT protocol adapted for self-help use. Those in the waitlist group will complete surveys over four months and receive access to the intervention after the study finishes. During the study, participants will complete five surveys over four months to assess symptoms and other outcomes. Researchers will measure misophonia symptoms using the Selective Sound Sensitivity Syndrome Scale at 16 weeks, along with quality of life, general distress, and psychological flexibility at several time points. The study will analyze changes over time to determine the intervention's feasibility and impact, aiming to offer accessible, evidence-based treatment for misophonia.

Researchers are evaluating how well inotuzumab ozogamicin works when combined with frontline chemotherapy in treating young adults aged 18 to 39 years who have newly diagnosed B acute lymphoblastic leukemia (ALL). This Phase III trial aims to confirm the safety and effectiveness of adding inotuzumab ozogamicin, a monoclonal antibody that targets cancer cells, to a pediatric-inspired chemotherapy regimen called CALGB 10403. The study also explores the impact of this combination on survival, minimal residual disease, genetic factors, treatment side effects, and medication adherence. Participants begin with remission induction therapy that includes oral allopurinol, intravenous and intrathecal chemotherapy drugs such as daunorubicin, vincristine, dexamethasone, pegylated L-asparaginase, and methotrexate, along with bone marrow tests. Those who respond to induction are randomized to one of two groups: one receives standard chemotherapy courses including consolidation, maintenance, and intensification phases, while the other receives inotuzumab ozogamicin infusions in addition to the same chemotherapy regimen. Treatments are given by mouth, intravenous, subcutaneous, or intrathecal routes on specific days over several courses lasting up to three years for maintenance therapy. Throughout the study, participants undergo regular bone marrow biopsies, blood tests, and biomarker analyses to monitor disease status and treatment effects. Researchers assess event-free survival, disease-free survival, overall survival, treatment toxicity, genetic markers, and medication adherence using electronic monitoring. After treatment ends, patients are followed monthly for the first year, then less frequently up to ten years to track long-term outcomes and safety.

Researchers are investigating treatments for patients with high-risk smoldering multiple myeloma in this phase III trial. The study compares the effects of lenalidomide and dexamethasone given with or without daratumumab. These drugs work in different ways to stop tumor growth, and the combination with daratumumab, an immunotherapy, may better interfere with tumor cell growth and spread. The trial aims to assess overall survival, progression-free survival, treatment safety, and quality of life among participants. Participants are randomly assigned to one of two treatment groups. One group receives daratumumab intravenously on specific days across up to 24 cycles, combined with daily oral lenalidomide for 21 days and oral dexamethasone on days 1, 8, 15, and 22 for 12 cycles. The other group receives only lenalidomide and dexamethasone on the same schedule for up to 24 cycles. Treatment continues every 28 days until disease progression or unacceptable side effects occur. During the study, participants undergo regular assessments including blood tests, bone marrow biopsies, imaging scans, and patient questionnaires to monitor treatment effects and quality of life. Researchers track overall survival for up to 15 years, evaluate minimal residual disease, and monitor medication adherence and adverse events. Follow-up visits occur every 3, 6, or 12 months after treatment ends to continue monitoring health outcomes.

Researchers are evaluating listener training to improve communication for people with dysarthria caused by Parkinson's disease (PD). Dysarthria often reduces speech intelligibility, leading to social isolation and difficulty participating in conversations. Traditional speech therapies can be challenging for people with advanced PD due to cognitive and physical limitations. This study aims to shift the focus from the patient to their primary communication partners by training them to better understand dysarthric speech and enhance overall communication outcomes. The intervention involves partner participants listening to audio phrases of the patient's speech accompanied by written transcriptions. They use these to improve their ability to understand the patient's speech. This behavioral training is designed to help communication partners adapt to the speech changes associated with PD. The study uses a randomized controlled trial design with repeated measures to assess the effectiveness of this listener training. Participants and their partners will undergo assessments before training, during training, immediately after, and at one week and one month post-training. The study measures speech intelligibility to evaluate improvements. Additional evaluations include listening effort, comprehension, and communication participation. Researchers will also collect feedback through interviews to understand the intervention's feasibility and effectiveness in real-world settings.

Researchers are evaluating a screening and multi-sub-study randomized phase II/III trial called Lung-MAP, designed for patients with previously treated non-small cell lung cancer. The trial aims to establish a genomic screening method to assign patients to biomarker-driven or non-matched sub-studies. Depending on the cancer biomarker type, participants may receive new targeted cancer therapies or combinations compared to standard care, with the goal of approving new treatments. An optional ancillary study explores patient and physician attitudes about returning genetic findings related to germline mutations. The study involves testing patient specimens to determine eligibility for various sub-studies under the Lung-MAP protocol. Patients undergo screening to analyze tumor tissue and blood samples for biomarkers including PD-L1 and c-MET. Those requiring a fresh biopsy also submit blood for circulating tumor DNA testing. Sub-study assignment depends on the molecular profile results. This screening process includes both patients progressing after prior therapy and those pre-screened before progression on current treatment. Participants provide informed consent and tumor tissue that meets quality standards for testing. Researchers collect clinical data including smoking history and performance status. Outcomes focus on screening success, such as adequate tissue submission and matching to biomarker-driven sub-studies, tracked for up to three years. The study also monitors patient and physician knowledge and preferences regarding genomic findings. Participation duration varies based on screening and sub-study assignment.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating how well radiation therapy works compared to observation in patients with newly diagnosed grade II meningioma that has been completely removed by surgery. This phase III trial aims to determine the clinical benefit of adding radiotherapy after gross total resection of the tumor, while also assessing overall survival, disease-specific survival, side effects, cognitive function, patient-reported outcomes, and biomarker validation. Participants are randomly placed into one of two groups: the first group undergoes observation with regular MRI scans and blood collections, while the second group receives intensity-modulated radiation therapy or proton beam radiation therapy five days a week for about 6.5 to 7 weeks. Treatment continues up to a total of 33 radiation sessions unless the disease progresses or unacceptable side effects occur. Both groups are monitored with imaging and blood samples throughout the study. After treatment, participants are followed up at 3, 6, and 12 months, then every six months for the second and third years, and yearly up to 10 years. Researchers measure progression-free survival from randomization until disease progression or death. The study also collects tissue and specimen samples for future research and monitors patients for side effects and quality of life over the long term.

Researchers are evaluating ways to improve advance care planning (ACP) among underserved communities, who often receive lower quality end-of-life care and unwanted, costly treatments. This study compares two conversation-based tools designed to encourage discussions about end-of-life wishes and motivate ACP behaviors. The goal is to increase high-quality end-of-life care, reduce health disparities, and lessen unnecessary suffering for patients and families. The study is a cluster randomized controlled trial involving 75 underserved communities across the US. It compares a serious conversation game called Hello, the widely used Conversation Project (CP) Starter Kit, and usual care where only an advance directive is distributed. The Hello game has 32 questions prompting sharing of values and beliefs about end-of-life issues, while the CP Starter Kit is a workbook with prompts and resources to facilitate conversations. The third group receives a general conversation game called Table Topics. Participants include adults from underserved populations who have not completed an advance directive in the past 5 years. Researchers will assess completion of a visually verified advance directive six months after the intervention. Other ACP behaviors will also be measured. The study involves community events, follow-up, and data collection to understand which tools best engage underserved groups in ACP and improve end-of-life care outcomes.