Rocklin

Hidradenitis suppurativa HS is a painful inflammatory skin condition affecting areas like the underarms, groin, and genital regions. This trial evaluates the safety and effectiveness of upadacitinib, an oral drug approved for other inflammatory diseases, in adults and adolescents with moderate to severe HS who have not responded well or cannot tolerate anti-TNF therapies. The study is double-blinded and involves multiple treatment periods to assess disease activity and side effects. Participants will take oral tablets of either upadacitinib or a placebo once daily during the first two periods, each lasting 36 weeks. In Period 1, participants are randomly assigned to receive either upadacitinib or placebo. Period 2 assigns participants to one of six groups based on their response in Period 1, with treatment continuing for 20 weeks. In Period 3, eligible participants continue their assigned treatment for an additional 68 weeks, followed by a 30-day follow-up. Throughout the study, participants will attend regular outpatient visits where medical assessments will monitor treatment effects and side effects. Questionnaires and clinical evaluations will be completed to measure changes in disease activity and quality of life. The trial aims to track the percentage of participants achieving clinical response and the occurrence of adverse events over the entire study duration, which may be longer than standard care treatments.

Researchers are evaluating whether adding immunotherapy drugs brentuximab vedotin and nivolumab to the standard treatment of chemotherapy with or without radiation improves survival for patients aged 5 to 60 with early stage classical Hodgkin lymphoma. This phase III trial compares progression-free survival and overall survival between the standard therapy and the immunotherapy-enhanced approach, as well as patient-reported outcomes and long-term side effects. Participants initially receive two cycles of ABVD chemotherapy every 28 days and then undergo imaging to classify their early response. Based on risk level and response, patients are assigned to one of eight treatment arms that include either continuing standard chemotherapy, receiving immunotherapy drugs, or combinations with involved-site radiation therapy. Treatments are delivered intravenously or orally in cycles lasting 28 days. Imaging and blood samples are collected throughout the trial. Participants are monitored regularly with PET scans, CT or MRI imaging, and blood tests. Follow-up visits occur every 3 months in the first year, then every 6 months for years two and three, and annually up to 12 years from registration. Researchers assess survival outcomes, adverse events, patient-reported symptoms and quality of life, and metabolic tumor burden. Long-term effects such as cardiovascular and pulmonary health are also evaluated using questionnaires and clinical assessments.

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 evaluating the effectiveness of remibrutinib compared to dupilumab as add-on treatments for adults with moderate to severe chronic spontaneous urticaria CSU that is not well controlled by second generation H1-antihistamines sgH1-AH. This Phase 3b, multi-center, randomized, double-blind, double-dummy study focuses on early treatment effects within 4 weeks. The study addresses the need for better management of CSU symptoms such as hives and itch. Participants will be assigned to one of two treatment groups one group will receive remibrutinib tablets twice daily plus placebo injections, while the other group will receive dupilumab injections with matching placebo tablets. Both groups continue their stable background therapy of sgH1-AH daily. The study includes a screening period up to 4 weeks, a 12-week core double-blind treatment period, and an optional 12-week open-label extension where all participants may receive remibrutinib if it is not commercially available. After treatment, safety follow-up occurs for up to 12 weeks, with phone calls and possible site visits. Participants will be monitored through regular assessments including symptom severity scores, urticaria activity scores, and daily diaries. Safety follow-up includes phone calls and visits depending on treatment continuation. The main outcome is the change in weekly urticaria activity score at Week 4. Other measures include severity of hives and itch at Weeks 1 and 4. Total study participation may last up to 24 weeks, including optional extension and follow-up phases.

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 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 the use of carboplatin chemotherapy given before surgery in patients with high-risk prostate cancer who have inherited mutations in the BRCA1 or BRCA2 genes. This phase II trial aims to determine how well carboplatin works in shrinking tumors prior to surgery and to assess its impact on disease progression and survival. The study also monitors treatment side effects and collects tissue samples for future research. Participants receive carboplatin intravenously before undergoing prostate surgery. Those who show signs of disease progression after surgery will have imaging tests such as CT, MRI, chest X-ray, or PSMA PET scans. Blood samples are collected throughout the trial to monitor health and support additional studies. The study includes detailed follow-up to evaluate treatment outcomes and safety. During the trial, participants will have regular assessments including physical exams, PSA tests, and imaging scans if needed. Researchers will review the rate of complete tumor response after carboplatin treatment at surgery and track progression-free survival and overall survival over time. Safety and side effects of the treatment are closely monitored. Participation may last up to five years with ongoing collection of health data and specimens.

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.

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.