Tifton

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

Researchers are evaluating how factors like age, gender, other medical conditions, and the type of immunotherapy affect the development of side effects in patients with malignant solid tumors receiving immune checkpoint inhibitor (ICI) therapy. The study aims to develop and validate a risk prediction model for serious immune-related side effects during the first year of ICI treatment. Additional goals include tracking the occurrence of various side effects, quality of life, patient-reported symptoms, and treatment patterns over 12 months, along with studying biological markers that may predict side effect risk. Participants will have tissue samples collected at the start of their cancer treatment and will complete questionnaires at baseline and at weeks 4, 12, 24, and 52. Blood samples may also be collected at multiple times during the study. The study focuses on patients receiving standard-of-care ICI therapy for solid tumors, without combination chemotherapy or other non-ICI treatments. During the study, participants will complete patient-reported outcome forms and health questionnaires to assess side effects and quality of life. Researchers will monitor the occurrence of severe immune-related side effects over 52 weeks and evaluate biological markers from blood and tissue samples. The study also assesses the use of electronic methods for collecting patient data. Total participation includes assessments over approximately one year following treatment start.

Researchers are studying cancer cachexia (CC), a syndrome involving weight, muscle, and fat loss in patients with advanced colorectal, lung, or pancreatic cancer that cannot be removed by surgery or is at stage IV. This study aims to identify different diagnostic subtypes of CC based on host characteristics such as symptoms, physical activity, blood biomarkers, and body composition. The goal is to better understand the varied causes of CC to improve diagnosis and develop more effective treatments tailored to individual patients. Participants will complete surveys and physical function tests that each take about 30 minutes. They will provide blood and archived tumor samples and wear a device called an actigraph for 7 days to monitor sleep and activity. Standard care scans like CT or PET/CT will be done during the study. Data will be collected at the start and again at 3 months, with continued review of medical records up to 1 year. These procedures help researchers study changes in CC characteristics over time and explore tumor factors linked to this condition. During the study, patients will undergo assessments of weight, muscle loss, symptoms, physical activity, and function. Researchers will analyze blood samples, tumor tissue, and medical images while reviewing health records. The main outcome is identifying distinct CC subtypes and their association with survival. Follow-ups occur at 3 months and 1 year to track changes and outcomes. The study involves no treatment but focuses on observation and data collection to support future CC diagnosis and therapy improvements.

Researchers are conducting the FLEX Registry to study patients with stage I to III breast cancer who receive MammaPrint and BluePrint testing on a primary breast tumor. This large-scale, population-based, prospective registry aims to create a comprehensive database of full genome expression linked with clinical data to explore new gene associations that may have prognostic or predictive value. The registry uses an adaptive design, allowing additional targeted substudies and arms to be added over time. The study involves patients from over 125 U.S. institutions, with an anticipated enrollment of around 30,000 participants. Treatment decisions are made by physicians following NCCN-approved regimens or recognized alternatives. MammaPrint and BluePrint tests are performed by Agendia using the full genome testing array. Data collection occurs at enrollment, during treatment, and at follow-up intervals of 1, 3, 5, and 10 years after diagnosis. Participants will have clinical data entered online at specified time points, with the goal of generating hypotheses for targeted subset analyses and further trials based on the genetic data collected. Outcome measures include the creation of a large registry for gene expression and clinical data over 10 years and the development of shared registry infrastructure to study smaller patient groups. This is an observational phase IV study focused on long-term data gathering and analysis.

Researchers are evaluating two chemotherapy treatments, mFOLFIRINOX and mFOLFOX, with or without the immunotherapy drug nivolumab, for advanced, unresectable, or metastatic HER2 negative adenocarcinoma of the esophagus, gastroesophageal junction, and stomach. This phase III trial aims to determine whether adding irinotecan to the usual FOLFOX regimen improves overall survival and other outcomes such as progression-free survival, response rates, and treatment tolerability. The study also explores biomarkers like PD-L1 combined positive score and cell free DNA to understand treatment effects better. Participants are randomly assigned to one of two treatment groups. One group receives fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with nivolumab as needed, while the other group receives fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with nivolumab as needed. All drugs are given intravenously. Throughout the trial, patients undergo MRI and CT scans and may provide blood samples for additional testing. During the study, participants are closely monitored for overall survival for up to two years after randomization. Researchers assess safety, side effects, and patient-reported outcomes to evaluate treatment tolerability. The trial also tracks progression of disease and response to therapy using imaging and other clinical evaluations. Participation includes regular imaging, blood collection, and completing questionnaires to help understand the impact of these treatments.

Researchers are evaluating whether using the PAGODA algorithm to guide chemotherapy dosing can reduce unplanned delays during chemotherapy for cancers in the gastrointestinal system compared to usual care. This study focuses on patients receiving FOLFOX chemotherapy, a standard treatment for various gastrointestinal cancers including esophageal, stomach, colon, rectal, and others. The trial aims to compare the proportion of chemotherapy cycles with unplanned delays, as well as secondary measures like healthcare contact days, incidence of moderate-to-severe neutropenia, and relative dose intensity of chemotherapy drugs. Participants are randomized into two groups. One group receives chemotherapy delays and dose changes based on the treating clinician's judgment during cycles 2 to 7 of FOLFOX chemotherapy. The other group receives dose modifications guided by the PAGODA algorithm, with final decisions by the clinician, during the same cycles. The chemotherapy drugs used include oxaliplatin, folinic acid, and fluorouracil, all given intravenously. The study is interventional and compares the algorithm-guided treatment to standard care. Throughout the trial, participants will be monitored for unplanned chemotherapy delays across cycles 2 to 7, with each cycle lasting 14 days. Researchers will also track healthcare contact days, neutrophil counts, and dose intensity of chemotherapy drugs. Safety and effectiveness measures will be assessed during the treatment period to understand how the PAGODA algorithm affects treatment delivery and patient outcomes.