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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 a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

This research aims to evaluate an online intervention for adults with misophonia, a condition involving strong emotional reactions to specific sounds that affect daily life and well-being. The study will compare the effectiveness and acceptability of a fully automated digital Acceptance and Commitment Therapy ACT program against a waitlist control group in 100 adults with clinically significant misophonia. Participants will be randomly assigned to either the intervention group, who will complete an 8-module ACT-based online program focusing on acceptance, cognitive defusion, present moment awareness, values clarification, and functional adaptations over four months, or the waitlist group, who will complete surveys without treatment during the study period and receive access to the intervention afterward. Throughout the study, participants will complete five surveys at baseline, mid-intervention, post-intervention, and at one- and two-month follow-ups to assess misophonia symptoms, psychological flexibility, distress, and quality of life. Researchers will measure outcomes using tools like the Selective Sound Sensitivity Syndrome Scale and track feasibility and acceptability of the digital program. The total participation period is four months, with ongoing monitoring and follow-up assessments.

Researchers are studying how well inotuzumab ozogamicin works when combined with frontline chemotherapy in treating young adults aged 18 to 39 years with newly diagnosed B acute lymphoblastic leukemia that is CD22 positive. This phase III trial investigates the side effects and effectiveness of this combination compared to chemotherapy alone, aiming to improve event-free survival and other outcomes. The study also explores genetic and molecular markers to better understand treatment response and risks. Participants receive a pediatric-inspired chemotherapy regimen called CALGB 10403, which includes multiple courses of treatment remission induction, remission consolidation, interim maintenance, delayed intensification, and maintenance therapy. Some patients also receive inotuzumab ozogamicin intravenously on specific days, followed by blinatumomab if minimal residual disease is detected. Treatment cycles repeat according to response and tolerance, with additional therapies like rituximab and radiation as needed. Imaging and laboratory tests are done throughout. During the trial, participants undergo regular assessments including bone marrow biopsies, blood tests, and imaging such as echocardiography or multigated acquisition scans. Researchers measure outcomes like event-free survival, disease-free survival, overall survival, response rates, and treatment side effects for up to 10 years. After treatment, patients are followed closely every few months for up to 10 years to monitor long-term effects and disease status.

Researchers are evaluating the effects of lenalidomide and dexamethasone with or without daratumumab in treating patients with high-risk smoldering multiple myeloma. This phase III trial aims to compare overall survival, progression-free survival, response rates, and safety between these treatments. The study also explores patient-reported quality of life, treatment adherence, minimal residual disease status, and imaging associations during therapy. Participants are randomly assigned to one of two treatment groups. The first group receives daratumumab intravenously on a detailed schedule across up to 24 courses, plus oral lenalidomide daily for 21 days and dexamethasone on specific days during the first 12 courses. The second group receives only oral lenalidomide and dexamethasone on a similar schedule for up to 24 courses. Treatment cycles repeat every 28 days unless disease progression or unacceptable side effects occur. During the study, participants complete quality-of-life questionnaires and undergo laboratory tests, including minimal residual disease assessments and PETCT imaging. Safety is closely monitored, especially infusion-related reactions and toxicity. After treatment, patients are followed for up to 15 years with periodic visits every 3 to 12 months to track long-term outcomes and survival.

People with dysarthria caused by Parkinsons disease often have trouble being understood, which can lead to less participation in social situations and feelings of isolation. This trial evaluates listener training as a new approach to improve communication by helping the communication partners of people with Parkinsons better understand their speech. The study aims to fill a gap where many patients cannot benefit from traditional speech therapies due to cognitive or physical challenges. The trial compares listener training, where partners listen to audio phrases along with written transcriptions to improve their understanding of dysarthric speech, against a control condition involving speech without disorders. This behavioral intervention is delivered through individual audio and text exercises that focus on perceptual learning. The study uses a randomized, double-blind design to measure immediate and retained improvements in speech intelligibility and related communication benefits. Participants will be assessed multiple times, including before training, during training, immediately after, one week later, and one month later. Researchers will measure speech intelligibility, listening effort, comprehension, and communication participation. The study also involves interviews with patients and partners to understand how well the listener training works and how it can be applied in clinical settings. The total participation period includes these assessments and follow-ups over one month.

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.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating how well radiation therapy works compared with observation in patients who have a newly diagnosed grade II meningioma that has been completely removed by surgery. This phase III trial aims to determine the clinical benefit of adding radiation therapy after complete tumor removal and also studies overall survival, disease-specific survival, side effects, neurocognitive function, patient-reported outcomes, and biomarker correlations. Participants are randomly assigned to one of two groups. One group undergoes observation with regular MRI scans and blood collection throughout the study. The other group receives intensity-modulated radiation therapy IMRT or proton beam radiation therapy five days a week for about 6.5 to 7 weeks, totaling 33 treatment sessions, unless disease progression or unacceptable side effects occur. Both groups continue to have MRI scans and blood tests during the study. Participants are followed for up to 10 years after treatment or observation, with visits scheduled at 3, 6, and 12 months, then every 6 months for years 2 and 3, and yearly thereafter. The study measures time without disease progression as the main outcome, along with survival rates, adverse events, cognitive function changes, and adherence to treatment protocols. Tissue and blood samples are also collected for ongoing research.

Researchers are evaluating how well serum tumor marker directed disease monitoring STMDDM works compared to usual care in patients with hormone receptor positive, HER2-negative metastatic breast cancer. This trial aims to see if monitoring with serum tumor markers can provide similar overall survival outcomes to the standard approach, which involves regular imaging scans. The study also looks at healthcare costs, patient anxiety, and quality of life related to these monitoring methods. Participants are randomly assigned to one of two groups. In the usual care group, patients receive imaging studies at least every 12 weeks and may have serum tumor marker tests as determined by their doctor. In the STMDDM group, patients have blood tests for specific tumor markers every 4 to 8 weeks, and imaging scans are only done if these markers indicate a possible progression of disease. Both groups continue their monitoring for up to 312 weeks unless the disease progresses. During the study, participants undergo regular assessments including blood tests for tumor markers, imaging scans as needed, and questionnaires about anxiety and quality of life. Researchers track overall survival for up to 312 weeks and compare healthcare costs and patient-reported outcomes for up to 48 to 102 weeks. The study also collects data on how often and by what methods disease monitoring is performed, along with patient and physician preferences related to monitoring.