Thief River Falls

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.

Researchers are evaluating different combinations of drugs to treat newly diagnosed multiple myeloma in patients who are not eligible for stem cell transplant and are considered frail or intermediate-fit based on age, other health conditions, and functional status. This phase III trial compares three induction regimens followed by either single or double maintenance therapy to see which combination works best to control the cancer and improve survival. The study also examines patient quality of life, safety, and other treatment effects over time. Patients are randomly assigned to one of three treatment groups. The first group receives bortezomib, lenalidomide, and dexamethasone for up to nine 28-day cycles, followed by lenalidomide maintenance. The second group receives daratumumab and hyaluronidase-fihj, lenalidomide, and dexamethasone for induction, followed by lenalidomide maintenance. The third group has the same induction as the second group but receives both daratumumab and lenalidomide during maintenance. Treatments are given by injection or orally on specific days within each cycle, and continue as long as the disease does not progress or side effects are unacceptable. Participants undergo assessments including tumor measurements, blood tests, patient-reported questionnaires, and blood sample banking for future research. After completing treatment, patients are followed up every three months for one year, then every six months for two years, and annually for up to ten years to monitor progression, survival, and quality of life. The main outcomes measured are progression-free survival and overall survival, with additional evaluations of response rates, safety, and symptom reports up to ten years after starting the study.

Researchers are comparing two treatment approaches for patients with stage II to IIIB non-small cell lung cancer (NSCLC) that can be surgically removed. The study evaluates whether giving standard therapy both before and after surgery (perioperative) is more effective than giving it only after surgery (adjuvant). The trial is phase III and aims to understand which approach leads to better survival and fewer complications in patients with resectable lung cancer. Participants are randomly assigned to one of two treatment groups. In the first group, patients have surgery within 28 days of joining the study, followed by up to four cycles of platinum-based chemotherapy and up to one year of immunotherapy if the cancer does not progress or cause unacceptable side effects. In the second group, patients receive chemotherapy combined with immunotherapy before surgery, then undergo surgery, and continue immunotherapy after surgery for up to one year under similar conditions. Throughout the study, patients may have CT scans, and possibly MRI or PET/CT scans at the start. During the trial, researchers will monitor patients closely over time, including follow-up visits every six months for up to 10 years after treatment ends. They will assess outcomes such as survival without events like cancer recurrence or progression, overall survival, rates of surgery and complete tumor removal, side effects leading to treatment stops or hospitalizations, and the body's response to treatment. This comprehensive monitoring helps evaluate the benefits and risks of each treatment approach.

Researchers are evaluating two different monitoring approaches for pancreatic cysts and associated biomarkers to improve risk detection of progression to pancreatic cancer. This observational study aims to compare more frequent versus less frequent monitoring schedules and identify biomarkers from blood tests and imaging that may better predict the development of concerning features or high-risk signs. The study also assesses patient quality of life, financial distress, anxiety, and healthcare costs related to these surveillance programs. Participants undergo magnetic resonance imaging (MRI), computed tomography (CT), or endoscopic ultrasound (EUS) scans, as well as blood sample collections throughout the trial. The study originally randomized patients into two surveillance arms: a low-intensity group with less frequent imaging and a high-intensity group with more frequent imaging based on cyst size. Patients may also undergo biopsies, fine needle aspiration, and surgery as clinically needed. The study is closed to new accrual but continues follow-up. Participants are followed every 6 to 12 months for up to 5 years after enrollment. Researchers collect imaging results, blood samples, and clinical data to track the development of worrisome cyst features or high-risk stigmata. They also evaluate patient-reported outcomes including quality of life, anxiety, and financial distress. Safety and treatment pathways are documented, and the primary outcome focuses on the time to detecting concerning cyst features on imaging over the 5-year period.

Researchers are studying hair loss caused by endocrine therapy in both postmenopausal and premenopausal women with breast cancer. Hair loss is a common and distressing side effect of cancer treatments, and this study aims to better understand how often it occurs, its timing, duration, and severity, especially related to different types of endocrine therapies. The study compares women receiving tamoxifen, aromatase inhibitors, aromatase inhibitors with CDK4/6 inhibitors, and those not receiving endocrine therapy. This observational study involves patients completing questionnaires and surveys about their hair loss. Medical records will also be reviewed to gather information. The study includes four main groups of postmenopausal women and a premenopausal group that has already completed enrollment. Participants answer questions every three months, starting within two weeks of beginning endocrine therapy or CDK4/6 inhibitor treatment. Participants will provide detailed reports about their hair loss symptoms and complete regular surveys to measure the impact on quality of life. Researchers will analyze patient-reported data on hair loss incidence and severity up to two years. The study helps characterize treatment-related alopecia and its effects, supporting better understanding of this side effect during breast cancer therapy.

Researchers are evaluating whether adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival in premenopausal women with early-stage, estrogen receptor-positive, HER2-negative breast cancer. This Phase III trial focuses on patients with specific 21-gene recurrence scores and aims to clarify the best treatment approach for younger women, who face higher risks despite current therapies. The study addresses the uncertainty about the role of ovarian suppression combined with chemotherapy versus ovarian suppression alone in this patient group. Participants are randomly assigned to one of two treatment groups: one receiving ovarian function suppression with an aromatase inhibitor for 5 years, and the other receiving adjuvant chemotherapy followed by the same ovarian suppression and aromatase inhibitor regimen. The choice of drugs and dosing schedules for the aromatase inhibitor and GnRH agonist are determined by the investigators, with common options including monthly or every-three-months administration of agents like goserelin, leuprolide, or triptorelin. Endocrine therapy may continue beyond five years at the investigator’s discretion, and bilateral oophorectomy can substitute for ovarian suppression if preferred. Throughout the trial, participants will be closely monitored over 11 years for outcomes including invasive breast cancer-free survival, overall survival, distant recurrence-free interval, and breast cancer-free interval. Evaluations of menopausal symptoms and pain during aromatase inhibitor therapy will be conducted one year after randomization. The study involves regular assessments and follow-up to track the effectiveness and impact of the treatments on patients’ health and quality of life.

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.