Seneca

Researchers are evaluating the effectiveness of a peer recovery coaching intervention called RC-Link for patients hospitalized due to medical complications from Alcohol Use Disorder AUD. This study aims to improve recovery outcomes by reducing heavy drinking, enhancing biopsychosocial functioning, and achieving remission from AUD, guided by the new NIAAA definition of recovery. The study will also explore mechanisms behind heavy drinking using daily ecological momentary assessment EMA and assess the cost-effectiveness of the RC-Link program through a randomized controlled trial design. The trial compares two groups one receiving bedside peer recovery coaching initiated during hospitalization plus six months of ongoing support, and a control group receiving a brief intervention, usual care with a referral list, and follow-up contact after the study period. The RC-Link program involves personalized recovery planning with a peer coach and regular contact at least twice a week via phone, virtual, or in-person meetings, using a standardized coaching checklist to provide socioemotional, instrumental, and informational support. Participants will be assessed at baseline, monthly during the six-month intervention, and six months after intervention completion. Evaluations include heavy drinking frequency, remission status based on DSM-5 criteria, biopsychosocial functioning, cost-effectiveness, coping, treatment and social support engagement, hospital utilization, breath alcohol content levels, and craving changes. This comprehensive monitoring aims to understand how peer recovery coaching affects long-term recovery outcomes for hospitalized AUD patients.

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.

This trial investigates monitoring and treatment options for patients with low risk and standard risk metastatic germ cell tumors, which are cancers that start in the cells that produce sperm or eggs. The study aims to find out if active surveillance after surgical removal of low risk tumors can maintain high survival rates, and whether carboplatin or cisplatin chemotherapy works better for treating standard risk tumors in children, adolescents, and young adults. Patients with low risk tumors undergo observation after surgery and may transfer to a standard risk treatment arm if the tumor recurs. Those with standard risk tumors are randomly assigned to receive one of two chemotherapy regimens one containing carboplatin, bleomycin, and etoposide, or the other containing cisplatin, bleomycin, and etoposide. Treatments are given intravenously in cycles every 21 days for up to 3 or 4 cycles depending on the group. Throughout the study, patients have imaging scans, blood tests, tumor biopsies, and pulmonary function tests to monitor response and side effects. Participants are followed closely during treatment and afterward with regular check-ups including CT, MRI, and chest X-rays, as well as blood sample collections. Follow-up visits occur every 2 months for the first year, then every 3-6 months up to 2 years, every 6 months for years 3 to 5, and annually up to 10 years. Researchers measure overall survival, event-free survival, hearing loss, body composition, tumor markers, and patient-reported outcomes related to hearing and neuropathy. This long-term monitoring helps assess the effects and safety of chemotherapy and surveillance strategies.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy regimen can improve outcomes for patients with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial focuses on comparing breast cancer event-free survival and other measures between patients receiving chemotherapy alone and those receiving chemotherapy with durvalumab. Immunotherapy may help enhance the bodys immune response against cancer, while chemotherapy works to stop tumor growth in various ways. Participants are first tested for MP2 status using MammaPrint on previously collected tissue. Those with MP2 results are randomized into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for six cycles, followed by doxorubicin and cyclophosphamide intravenously every 14 days for four cycles. The other group receives the same chemotherapy schedule combined with durvalumab given intravenously over 60 minutes on specific cycles. Mammography and optional tumor tissue and blood sample collections occur during the study. During the study, participants undergo assessments including mammography, tumor biopsies, blood tests, and quality-of-life questionnaires. Researchers measure outcomes such as event-free survival, response rates, relapse-free survival, overall survival, treatment side effects, and patient-reported fatigue and physical health. After treatment completion, participants are followed for up to 10 years to monitor long-term outcomes and survival. Specimens are also banked for future research.

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors ICIs. The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.

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 treatment options for patients newly diagnosed with multiple myeloma who are considered frail or intermediate-fit and who are not candidates for stem cell transplant. This phase III trial compares three different three-drug induction regimens followed by either single or double drug maintenance therapies. The study aims to find which drug combination best controls the cancer and improves patient outcomes while considering patients age, other health conditions, and physical function. Participants are randomly assigned to one of three treatment arms. In Arm 1, patients receive bortezomib, lenalidomide, and dexamethasone with bortezomib given subcutaneously and the others taken orally for up to 9 cycles, followed by lenalidomide maintenance. Arm 2 involves daratumumab with hyaluronidase-fihj given subcutaneously, lenalidomide, and dexamethasone for induction, followed by lenalidomide maintenance. Arm 3 includes the same induction as Arm 2, but maintenance therapy combines daratumumab with hyaluronidase-fihj and lenalidomide. Each cycle lasts 28 days, and treatment continues without disease progression or unacceptable side effects. During the trial, participants undergo regular assessments including tumor measurements, blood tests, and quality-of-life questionnaires. Researchers monitor progression-free survival, overall survival, response rates, minimal residual disease status, and patient-reported symptoms and health status. After completing treatment, patients are followed up every 3 months for one year, every 6 months for two years, and then annually for up to 10 years to monitor long-term outcomes and safety.

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.

The trial investigates treatments for younger patients with intermediate risk acute myeloid leukemia AML. It compares three therapy combinations cytarabine with daunorubicin, cytarabine with daunorubicin plus venetoclax, and venetoclax with azacitidine. This phase II study aims to evaluate whether adding venetoclax improves the elimination of leukemia cells compared to standard treatment, focusing on measurable residual disease MRD after remission. Participants are randomly assigned to one of three arms. Arm I receives daunorubicin intravenously on days 2-4, cytarabine intravenously on days 2-8, and venetoclax orally daily on days 1-11, with possible reinduction based on bone marrow assessment. Arm II receives azacitidine intravenously or subcutaneously on days 1-7 or 1-5 and 8-9, plus venetoclax orally daily on days 1-28 for two cycles. Arm III receives daunorubicin intravenously on days 1-3 and cytarabine intravenously on days 1-7, with possible reinduction depending on bone marrow results. Treatment continues unless disease progresses or side effects become unacceptable. During the trial, participants undergo bone marrow aspiration, blood sample collection, and heart function tests like echocardiography or MUGA scans. After treatment, follow-up visits occur at 4 weeks, then every 3 months for one year, every 6 months for the second year, and yearly afterward. Researchers assess outcomes such as undetectable MRD rates, remission rates, survival, relapse, and treatment side effects over several years.

This trial investigates treatments for older adults newly diagnosed with acute myeloid leukemia AML who have a specific gene mutation called IDH2. It compares the combination of ASTX727 and venetoclax with or without the addition of enasidenib. The study aims to see if adding enasidenib helps more patients achieve remission by targeting the IDH2 mutation that contributes to leukemia growth. Participants are randomly assigned to one of two groups. One group receives ASTX727, an oral combination of cedazuridine and decitabine, plus venetoclax daily for 28 days in repeated 28-day cycles. The other group receives the same treatment with the addition of enasidenib every day in the cycle. Treatment continues unless the disease worsens or side effects become unacceptable. Throughout the trial, patients undergo blood and bone marrow tests to monitor their response. During the study, participants have regular blood sample collections, bone marrow aspirations, and biopsies to assess disease status and treatment effects. After completing treatment, follow-up visits occur monthly for the first year, then every two months in the second year, every three months in the third year, and every six months up to five years or until death. The main outcome measured is the rate of remission without detectable leukemia after two treatment cycles. Safety and long-term outcomes are also tracked.