Nags Head

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 well serum tumor marker directed disease monitoring (STMDDM) works for patients with hormone receptor positive, HER2 negative metastatic breast cancer. The study compares STMDDM with the usual care approach to see if overall survival is not worse using STMDDM. The trial also looks at healthcare costs, patient anxiety, quality of life, and preferences related to disease monitoring. Patients are randomly assigned to one of two groups. One group receives usual care with imaging at least every 12 weeks and other monitoring at the doctor's discretion for up to 312 weeks if the disease does not progress. The other group has their serum tumor markers checked every 4 to 8 weeks, with imaging only if markers are elevated, also for up to 312 weeks without progression. Additional assessments include quality-of-life and anxiety questionnaires. Throughout the study, participants undergo regular evaluations including imaging, blood tests for tumor markers, and patient-reported outcome questionnaires. Researchers track overall survival up to 312 weeks after randomization, along with healthcare costs and patient experiences. Participants must provide informed consent and are monitored for safety during the study period.