Bryan

Researchers are evaluating how well active surveillance helps doctors monitor patients with low-risk germ cell tumors after surgical removal. The study also compares chemotherapy treatments using carboplatin versus cisplatin in pediatric, adolescent, and young adult patients with metastatic standard risk germ cell tumors. It aims to determine overall survival, event-free survival, and side effects such as hearing loss among these patients. The study includes patients with low-risk stage I ovarian immature teratoma or stage I non-seminoma or seminoma germ cell tumors who undergo observation. Patients with standard risk tumors are randomly assigned to receive one of four chemotherapy regimens combining bleomycin, etoposide, carboplatin, or cisplatin, given intravenously on specific days over cycles repeating every 21 days. Treatments continue for up to 3 or 4 cycles if no disease progression or unacceptable side effects occur. Throughout treatment and observation, patients undergo imaging scans, blood sample collection, tumor biopsies if needed, and pulmonary function tests. Participants will be followed with regular imaging and blood tests to monitor tumor response and recurrence, including CT, MRI, and chest x-rays. Follow-up visits occur every 2 months for the first year, then every 3 to 6 months through year 2, every 6 months for years 3 to 5, and annually up to 10 years. The study also assesses hearing outcomes, body composition, tumor marker decline, neuropathy, and serum microRNA over time to better understand treatment effects and patient quality of life.

Researchers are evaluating the addition of olaparib, a targeted therapy that blocks the PARP enzyme involved in DNA repair, in patients with pancreatic cancer who have had surgery to remove their tumor and carry a mutation in BRCA1, BRCA2, or PALB2. This phase II trial aims to determine if olaparib can improve relapse-free survival compared to placebo after chemotherapy completion. The study also explores overall survival and differences based on mutation type and chemotherapy received. Participants are randomly assigned to one of two groups. One group receives oral olaparib twice daily for 28-day cycles, up to 12 cycles, while the other group receives a placebo on the same schedule. Throughout treatment, patients undergo CT or MRI scans and blood collection. After treatment, patients are followed for up to 10 years with regular visits to monitor health and disease status. During the study, participants complete imaging scans and blood tests to assess disease progression and treatment effects. Researchers track relapse-free survival from the time of randomization until disease recurrence or death, with assessments extending up to 44 months. Safety and survival outcomes are monitored for up to 10 years. Follow-up visits occur 30 days after treatment and then every 4 months in the first year, followed by every 6 months for years 2 through 10.

Researchers are collecting blood and tissue samples from patients with and without cancer to evaluate tests that might help detect cancer early. This observational study aims to create a blinded reference set of blood samples from both cancer and non-cancer patients to validate blood-based multi-cancer early detection tests. The study also assesses test performance at the time of initial cancer diagnosis by tumor type and clinical stage. Participants complete a questionnaire at the start of the study and provide blood samples at registration and again 12 months later. Patients diagnosed with cancer may also provide tissue samples at these same time points. The study collects samples to support the development and validation of early detection assays, with no treatment interventions involved. During the study, participants fill out questionnaires and provide blood and possibly tissue samples. Researchers follow up with participants one year after study completion. The main outcome is the creation of a blinded reference set of blood samples to test early cancer detection methods. The study monitors test performance based on cancer type and stage, with all evaluations completed within one year of enrollment.

This research aims to collect data and samples from patients who experience side effects from immunotherapy used in cancer treatment. The goal is to better understand, predict, prevent, and treat these immune-related side effects, including serious adverse events, rare infections, or accelerated tumor growth. This observational study is led by the Alliance for Clinical Trials in Oncology and focuses on patients treated with immuno-oncology therapies who have experienced significant immune-related adverse events. Participants provide tissue and blood samples, with optional stool samples for those experiencing colitis, within 72 hours of confirming a serious immune-related adverse event and again one month later. The study also includes a review of patients' medical records for up to one year. This approach helps establish a national biorepository of biospecimens and clinical data for future research. During the study, participants will undergo sample collection at two time points and have their medical history reviewed over a year. Researchers will monitor the establishment of the biorepository and collect clinical data to support future studies. This process aims to improve knowledge about immune-related side effects from immunotherapy and contribute to better patient care over time.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer based on the presence or absence of circulating tumor DNA (ctDNA) after surgery. This Phase II/III trial focuses on patients with Stage IIB, IIC, or Stage III colon adenocarcinoma who have undergone tumor removal. The study aims to use ctDNA status to better predict the risk of cancer recurrence and guide decisions about adjuvant chemotherapy. Participants will be assigned to different treatment groups based on their ctDNA status after surgery. Patients without detectable ctDNA will undergo serial ctDNA monitoring without immediate treatment or receive standard chemotherapy regimens such as mFOLFOX6 or CAPOX for varying durations. Patients with detectable ctDNA will receive either standard chemotherapy or intensified regimens like mFOLFIRINOX. Treatments involve intravenous and oral chemotherapy drugs given over several cycles spanning weeks to months. Throughout the study, participants will have ctDNA testing using the Signatera test and be monitored for disease-free survival, overall survival, and recurrence up to five years after randomization. Safety and treatment adherence will also be tracked. Regular imaging and laboratory tests will assess disease status and organ function. The study may include re-randomization for patients who develop positive ctDNA during monitoring. Total involvement may last several years with follow-up for long-term outcomes.

This research aims to assess colorectal cancer rates in participants aged 45 to 70 who have 1 to 2 non-advanced adenomatous polyps. The study compares the outcomes of surveillance colonoscopy performed once at 10 years versus twice at 5 and 10 years after the initial colonoscopy. Colorectal cancer is a common and serious disease, and while colonoscopy screening reduces its incidence, the best timing for follow-up exams after finding small non-advanced adenomas is unclear. Participants are randomly assigned to one of two groups: one group receives surveillance colonoscopies at both 5 and 10 years after the qualifying colonoscopy, and the other group receives a single surveillance colonoscopy at 10 years. Colonoscopies follow standard quality guidelines and preparation instructions. All polyps found during the initial colonoscopy must have been completely removed for participants to be eligible. Throughout the study, participants will undergo colonoscopies according to their group assignment and will be monitored for the development of colorectal cancer over 10 years. Researchers will evaluate the incidence of colorectal cancer as the primary outcome. Participants' adherence to scheduled colonoscopies and any additional procedures will be tracked. This study is designed to provide clear evidence on the optimal timing of surveillance colonoscopy after detection of small adenomas, informing future guidelines and clinical practice.

Researchers are studying how certain factors like age, gender, other medical conditions, and the type of immunotherapy affect whether patients with malignant solid tumors develop mild or serious side effects from immune checkpoint inhibitor treatments. This observational study aims to develop and validate a model that predicts severe immune-related side effects during the first year of immunotherapy, while also assessing quality of life and adverse events over 12 months. The study is sponsored by the SWOG Cancer Research Network and includes translational medicine goals such as evaluating cytokine levels as predictors and establishing a tissue and blood sample repository. Participants will provide a tissue sample at the start of their routine cancer treatment and complete questionnaires at multiple time points: at treatment start, and weeks 4, 12, 24, and 52. They may also provide optional blood samples during the study. This design allows researchers to monitor immune-related side effects and patient-reported outcomes over time. During the study, participants will complete various questionnaires to report their quality of life, cognitive function, and side effects. Blood and tissue samples will be analyzed to explore predictive markers of toxicity. Researchers will track the occurrence of severe immune-related side effects over 52 weeks and assess changes in patient-reported outcomes. The study includes ongoing monitoring and data collection, with participation lasting approximately one year from treatment start.

This research aims to assess the feasibility and acceptability of adolescent and young adult (AYA) cancer patients completing patient-reported outcomes (PROs) based on their own priorities. The study involves a pilot randomized controlled trial comparing two groups: one group chooses five health-related quality of life (HRQOL) domains to report on (Choice PRO), while the other group completes five standard HRQOL domains (Fixed PRO). The study focuses on AYAs aged 18 to 39 with various cancer types who have been diagnosed within the past 12 weeks and are receiving or planning to receive cancer treatment. Participants will be randomized to either select five PRO domains from a dashboard at each assessment or complete a fixed set of five PRO domains including physical function, pain, cognitive function, social support, and finances. Assessments will be completed online at baseline, 1, 3, 6, and 12 months, using a combination of computerized adaptive tests and short forms. Reminder calls and text messages will be used to encourage adherence and reduce missing data. During the study, participants will complete questionnaires online through a system called EASEE-PRO. Researchers will evaluate completion rates and acceptability of PROs between the two groups, aiming for at least 75% completion and acceptability. Participants will also be asked about their preferences for sharing their PRO data with themselves, their families, and their healthcare providers. The study will help improve patient-centered care by incorporating AYA feedback into clinical trials and supportive care.

This research investigates how genetic factors influence the body's response to medications in patients with various conditions such as diabetes, cholesterol issues, cancer, blood pressure disorders, heart disease, respiratory illnesses including COPD, and adverse drug reactions. The study aims to help doctors select better medications by collecting genetic and health information from patients, especially those taking multiple medications or experiencing harmful side effects. The program also seeks to impact insurance coverage and government policies to support personalized medication care. Participants in this observational study are mainly patients who take five or more medications, including over-the-counter and recreational drugs, or those on blood pressure or depression treatments even if taking fewer medications. The study involves collecting medical history and genetic samples, such as blood, urine, and buccal swabs, and storing this information securely. Participants will be followed for five years to monitor medication effects and adverse drug reactions using tools like the Naranjo Scale and drug concentration tests. During the study, participants will complete detailed questionnaires, including quarterly surveys about adverse drug reactions, cognitive tests like mini-mental status exams, and quality of life assessments. Researchers will track changes in health status over five years and share deidentified data with the research community. This long-term observation helps evaluate how genetics affect medication safety and effectiveness, with ongoing monitoring of participants' health records and medication responses.

Researchers are evaluating adverse drug reactions (ADRs) related to taking multiple medications (polypharmacy) in patients at risk, using advanced pharmacogenomic technology. The study aims to improve medication management by integrating genomic data into electronic decision support tools. It also seeks to assess the activity of liver enzymes involved in drug metabolism and test the feasibility of combining whole genome sequencing data with electronic medical records and clinical workflows. Participants will be observed using pharmacogenomic tests, including genotyping and research-use-only whole genome sequencing, alongside comprehensive clinical assessments. The study will develop and refine a clinical decision support dashboard to help identify medication regimens that may need adjustment, replacement, or discontinuation. The research involves collecting genetic, urine, and blood samples and linking this information with patient medical histories and medication use patterns. During the study, participants will provide samples and undergo history and physical examinations. Researchers will track adverse drug reactions and emergency department visits over 180 days. The study will monitor pharmacogenomic genotypes paired with ADRs, using data to improve personalized medication guidance. Participants' safety and medication responses will be closely followed, with results aimed at supporting better care decisions in polypharmacy management.