Mount Vernon

Researchers are studying two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 genetic mutations. This trial compares bilateral salpingectomy, which removes only the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The goal is to find out if removing just the fallopian tubes with delayed ovary removal is nearly as effective as removing both from the start. Participants choose between two groups one undergoes bilateral salpingectomy with the option of later ovary removal, and the other undergoes bilateral salpingo-oophorectomy. Both groups have imaging tests like pelvic ultrasounds or pelvic MRIs during screening and provide blood samples throughout the study. Follow-up visits occur at multiple time points, including 10 to 60 days, 6 months, 12 months, 24 months, and then yearly for up to 20 years. During the study, researchers track if ovarian or related cancers develop and assess symptoms related to estrogen loss, quality of life, cancer-related distress, sexual function, menopausal symptoms, medical decision making, and any adverse events. Various questionnaires and imaging tests support these evaluations. Long-term safety and cancer risk reduction are monitored for up to two decades after surgery.

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.

This research aims to establish a national biorepository by collecting research data and samples from patients who experience side effects from immunotherapy treatments used in cancer care. It focuses on patients who have serious immune-related reactions, rare infections, or accelerated tumor growth after receiving immuno-oncology therapies. The goal is to help researchers better predict, prevent, and treat these side effects in the future. Participants will have tissue and blood samples collected within 72 hours after confirmation of a serious immune-related side effect and again one month later. For patients experiencing colitis, stool samples may also be collected. Alongside sample collection, medical records will be reviewed for up to one year. This study is observational and involves no experimental treatments. During the study, participants will provide biospecimens at two time points and allow access to their medical records for a year. Researchers will analyze these samples and clinical data to build a resource for future studies on immune-related adverse events. The main outcome is the establishment of this biorepository, which will be maintained for up to one year after enrollment.

This research aims to compare two methods of monitoring pancreatic cysts and to identify biomarkers that may help detect the risk of these cysts turning into pancreatic cancer. The study evaluates whether more frequent monitoring or less frequent monitoring leads to better patient outcomes and explores various blood and imaging biomarkers for improved risk prediction. Participants are observed through two different surveillance approaches that were previously randomized but are now closed to new enrollment. One approach involves lower intensity monitoring with MRI, CT, or endoscopic ultrasound EUS scans spaced out over years, while the other involves higher intensity monitoring with more frequent imaging based on cyst size. Throughout the study, patients may also provide blood samples and undergo biopsies, fine needle aspirations, or surgery as needed. Participants are followed up regularly for five years from registration, with imaging and blood tests at intervals depending on their assigned monitoring method. Researchers collect data on clinical features, anxiety, quality of life, financial distress, healthcare costs, and outcomes such as the development of concerning pancreatic cyst features or pancreatic cancer. The study uses these measures to assess the effectiveness of monitoring strategies and the predictive value of biomarkers.

Researchers are evaluating the effect of the Cost Communication and Financial Navigation CostCOM intervention on adherence to cancer care and financial burden in patients with malignant solid neoplasms. This study focuses on how financial hardship caused by out-of-pocket costs, employment changes, and insurance affects cancer treatment and quality of life. CostCOM aims to provide financial counseling and resource connections to reduce these burdens and improve adherence to care. Participants are randomized into two groups. One group receives a brochure describing financial navigation services Enhanced Usual Care, while the other group receives usual financial care plus CostCOM financial counseling sessions within 30 days of enrollment and again at 3, 6, and 12 months. Non-patient participants complete surveys and participate in interviews 15 to 39 months after the first patient enrollment. Participants complete surveys at baseline and at 3, 6, and 12 months to report on cost-related care non-adherence, financial hardship, financial worry, quality of life, and satisfaction with care. The study includes follow-up for 12 months after intervention completion. Non-patient participants also provide feedback on the CostCOM intervention through interviews. Researchers will monitor patient experiences and financial outcomes throughout the study.

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 investigating whether adding the drug Docetaxel to the usual hormone treatments, Androgen Deprivation Therapy ADT and Androgen-Receptor Pathway Inhibitor ARPI, can better control metastatic castration sensitive prostate cancer in men who have not responded optimally to initial hormone therapy. This phase III, international, open-label, randomized trial seeks to compare the effectiveness of this combined approach against the standard hormone therapy alone. Participants will be randomly assigned to receive either the standard hormone therapy with ADT plus ARPI or the same hormone therapy combined with Docetaxel chemotherapy. The trial focuses on men with metastatic prostate cancer who continue to have elevated PSA levels after 6 to 12 months of hormone-targeting treatment. Treatments are administered according to physician choice and assignment, and the study evaluates outcomes over a long period. During the trial, participants will be closely monitored with assessments including PSA levels and clinical progression over 39 months. Researchers will measure overall survival as the primary outcome, along with secondary outcomes such as PSA progression, PSA response, PSA kinetics, and progression-free survival. Participants must be accessible for treatment and follow-up to allow for complete documentation of treatment effects and adverse events throughout the study duration.

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 studying adolescent and young adult AYA cancer survivors who had Hodgkin or non-Hodgkin lymphoma to understand how social and genetic factors affect their health outcomes after treatment. These survivors face unique biological, clinical, psychological, and social challenges that may influence their risks for illness and early death compared to older or childhood cancer patients. The study aims to identify conditions increasing these risks and to better meet the needs of AYA cancer survivors. Participants will complete questionnaires about their quality of life and provide blood samples at the start of the study and again at 6, 12, 18, and 24 months. This observational study collects health and treatment information without administering any medical treatments. The study assesses social-environmental risks, individual resilience factors, and gene expression changes to understand their impact on survival and quality of life. Participants will be asked to fill out health-related questionnaires and provide blood samples multiple times over two years. Researchers will measure disease-free survival, overall survival, comorbidities, and quality of life during this period. The study involves ongoing monitoring through questionnaires and blood tests to gather detailed data on how social and genetic factors influence long-term outcomes for AYA lymphoma survivors.

Researchers are evaluating an online educational program called Current Together After Cancer CTAC to see if it helps colorectal cancer survivors who had surgery receive follow-up care that matches current guidelines. This phase III trial focuses on patients with stage II or III colorectal cancer who have had their tumors surgically removed. The study aims to improve patients knowledge about surveillance, their confidence in managing follow-up care, and satisfaction with the involvement of a supporter in their care. Patients in the trial are randomly assigned to one of two groups. One group and their supporter get access to the CTAC intervention website, which contains educational content and interactive modules related to colorectal cancer surveillance. The other group and their supporter receive access to a general health education website. Participants may review their assigned website as often as they like for up to 16 months. During the study, participants will complete questionnaires at baseline, 3 months, and 16 months to assess knowledge, self-efficacy, cancer worry, preferences, and satisfaction with supporter engagement. Researchers will measure whether patients receive colorectal cancer surveillance aligned with guidelines at 16 months. The study also explores how supporters participation relates to patient outcomes. Participants may be contacted via email or phone for study activities and are encouraged to complete all scheduled assessments.