Easton

Researchers are collecting blood and tissue samples from people with and without cancer to help evaluate new tests that could detect cancer early. This study aims to create a set of blinded blood samples from both cancer and non-cancer patients to validate these tests, focusing on multiple cancer types and stages. The goal is to improve early cancer detection through laboratory research. Participants complete a questionnaire at the start and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also have tissue samples collected at these times. The study includes patients with various cancer types and stages, as well as individuals without cancer, with some allowing enrollment before full cancer confirmation under specific conditions. During the study, researchers review the collected samples and questionnaire data to assess test performance by tumor type and clinical stage at diagnosis. Participants are followed for one year after completing the study. Key measurements include the provision of a blinded reference set of cancer versus non-cancer blood samples to support future clinical trials focused on blood-based multi-cancer early detection.

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.

Researchers are evaluating two digital mindfulness-based interventions to improve mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III randomized trial focuses on women diagnosed at or before age 50, who completed primary cancer treatments at least six months earlier. The study aims to compare the effectiveness of live instructor-led sessions via Zoom and a self-paced app-based program, exploring which approach best supports psychological health in this population. Participants will be assigned to one of three groups the live online mindfulness sessions MAPs LO conducted weekly for 6 weeks via Zoom, the MAPs App delivering the same content in shorter sessions over 6 weeks, or a meditation-only control group accessing guided audio meditations. Both English and Spanish speakers can participate in the live online and meditation groups, while the app is only available in English. Tablets and internet hotspots are provided if needed. All groups have access to the UCLA MARC mindfulness meditation app throughout the 6-month follow-up. During the study, participants will attend weekly sessions for the live group or engage with app content at home, with usage tracked to measure intervention dose. Researchers will assess depressive symptoms shortly after the intervention and again up to 6 months later, along with fatigue symptoms. They will also investigate factors influencing intervention effects, such as baseline distress and social determinants, and evaluate the cost-effectiveness of the programs. The total study duration includes a 6-week intervention period plus follow-up assessments out to 6 months.

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 treatments for patients with high-risk, locally advanced cervical cancer that has spread to nearby tissue or lymph nodes. This Phase III trial compares adding induction chemotherapy with carboplatin, paclitaxel, and pembrolizumab before standard chemotherapy, radiation, and pembrolizumab maintenance against the standard treatment of chemotherapy, radiation, and pembrolizumab maintenance alone. The study aims to investigate whether this induction approach improves progression-free survival and overall survival, while assessing treatment toxicity and biomarker effects. Participants are randomly assigned to one of two groups. In the standard care group, patients receive weekly cisplatin and pembrolizumab every three weeks alongside daily radiation therapy for 5 weeks, followed by brachytherapy for 4 to 5 treatments, and then pembrolizumab maintenance every six weeks for up to 15 cycles. In the experimental group, patients first receive induction chemotherapy with carboplatin and paclitaxel weekly for 3 weeks, plus pembrolizumab every three weeks for 2 cycles, then receive the same chemoradiation and pembrolizumab maintenance schedule, with radiation delivered in weeks 7 to 13. Treatment is given unless disease progression or unacceptable side effects occur. Throughout the trial, participants undergo imaging scans including PET, CT, chest x-ray, and MRI, along with blood sample collection to monitor disease and biomarkers. After completing treatment, patients are followed every 3 months for 2 years, then every 6 months for up to 3 more years. Researchers measure progression-free survival as the primary outcome and assess overall survival, adverse events, treatment completion, biomarker levels, and radiation quality. Safety and treatment effects are closely monitored during the study period lasting several years.

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 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.

This trial evaluates whether a shorter duration of HER2-targeted therapy is as effective as the standard length for treating early-stage HER2-positive breast cancer in patients who had a complete response after preoperative chemotherapy with trastuzumab. The study focuses on comparing 6 months versus 12 months of combined neoadjuvant and adjuvant HER2 blockade and also assesses quality of life and safety outcomes. The trial aims to determine if shorter treatment can maintain similar recurrence-free survival and reduce side effects. Participants are randomly assigned to receive trastuzumab and possibly pertuzumab either intravenously or subcutaneously every 21 days. One group receives treatment for up to 17 cycles about 12 months, while the other group receives treatment for up to 9 cycles about 6 months, as long as no disease progression or unacceptable toxicity occurs. Throughout the trial, patients undergo heart function tests echocardiography or MUGA and breast imaging mammography, ultrasound, or MRI. Optional blood and tissue samples may be collected for additional studies. Participants are followed for recurrence and survival for up to 10 years after treatment begins, with check-ins every 6 months for the first 5 years and then yearly afterward. The study measures recurrence-free survival, overall survival, local and distant cancer recurrence, and patient-reported quality of life using specific questionnaires. It also monitors serious side effects and symptoms like diarrhea, fatigue, and rash. This comprehensive follow-up helps evaluate long-term outcomes and treatment impact.

Researchers are investigating treatments for small cell lung cancer that has spread to the brain, focusing on whether stereotactic radiosurgery SRS is better at preserving memory and thinking abilities compared to whole brain radiation therapy that avoids the hippocampus HA-WBRT combined with the drug memantine. This phase III trial evaluates cognitive function, symptom burden, survival outcomes, and side effects in patients receiving these treatments. The study also explores brain imaging biomarkers and the economic impact of therapies. Participants are randomly assigned to one of two groups. One group receives stereotactic radiosurgery, which delivers a high dose of radiation directly to brain tumors over one or several days. The other group receives hippocampal-avoidant whole brain radiation daily for two weeks along with memantine taken orally once or twice daily for up to 24 weeks. Both groups undergo blood sample collection and magnetic resonance imaging MRI throughout the study period. During the study, participants complete neurocognitive tests measuring memory and thinking skills, as well as patient-reported questionnaires about cognitive difficulties and symptoms. After treatment, follow-up visits occur every 2 to 3 months for one year and then every six months thereafter to monitor disease progression, survival, adverse events, and other outcomes. The main measurement focuses on the time until neurocognitive failure, assessed up to one year after treatment.