Liquid Biopsy

Biliary tract carcinoma BTC includes cancers of the gallbladder, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma. It is a highly aggressive cancer with poor outcomes, ranking sixth in gastrointestinal cancer incidence and tenth in cancer-related deaths worldwide. Because early symptoms are often absent and the disease tends to recur and spread, only about 16.5% of patients can have curative surgery, and the overall 5-year survival rate is under 5%. Early and accurate detection is crucial to improve patient outcomes. This research aims to assess the use of cell-free DNA cfDNA methylation in blood as a liquid biopsy for diagnosing and managing BTC. The study involves several groups, including healthy individuals, patients with confirmed benign biliary lesions, other gastrointestinal cancers, and those with confirmed or suspected BTC. Researchers will analyze methylation patterns in circulating tumor DNA ctDNA, a small fraction of cfDNA that carries tumor genetic and epigenetic information. This approach is studied for its potential to detect BTC early, assist in differential diagnosis, monitor prognosis, and guide therapy. Different cohorts serve as internal training, validation sets, and independent validation groups. Participants will provide blood samples and undergo clinical evaluations to measure the accuracy of the ctDNA methylation test in diagnosing BTC. The study will assess diagnostic performance by cancer subtype and stage, and ability to distinguish BTC from other conditions. Vital signs, organ function, and other health markers will be monitored to ensure participant safety. The study welcomes adults aged 18 to 80 years, with follow-up and assessments continuing until May 2026 to evaluate the tests clinical utility.

Esophageal squamous cell carcinoma ESCC is a common and deadly cancer in China, with many patients diagnosed at advanced stages. This study evaluates a combined treatment approach using induction immunochemotherapy followed by concurrent chemoradiotherapy, aiming to improve outcomes for patients with locally advanced, unresectable ESCC. Researchers also focus on using circulating tumor DNA ctDNA to monitor treatment response and predict tumor progression, as ctDNA changes can appear before imaging detects recurrence. Participants receive induction immunochemotherapy consisting of toripalimab combined with paclitaxel and cisplatin every three weeks for two cycles. This is followed by radical concurrent chemoradiotherapy with weekly paclitaxel and cisplatin for five cycles along with radiotherapy delivered five days per week. The study dynamically monitors ctDNA levels at several points before treatment, before chemoradiotherapy, after 20 radiotherapy fractions, and every three months after treatment completion. During the study, participants undergo regular assessments including blood tests for ctDNA analysis and monitoring of tumor status. The main outcome measured is progression-free survival at one year. Safety and efficacy are tracked throughout the treatment and follow-up periods. The total participation duration and timing of assessments are carefully planned to evaluate the treatment strategy and its correlation with patient prognosis.

This research investigates adjuvant chemotherapy decision-making for patients with high-risk stage III colorectal cancer, specifically those with T4N or T1-3N2 disease. It evaluates the use of plasma circulating tumor DNA ctDNA methylation to guide treatment choices. The study is a randomized controlled trial sponsored by Fudan University, focusing on how adding bevacizumab to standard chemotherapy affects patient outcomes. Participants will be randomly assigned to one of two groups the control group will receive standard chemotherapy with FOLFOX or CAPOX for six months, while the intervention group will receive the same chemotherapy combined with bevacizumab for six months. Blood samples will be collected at one, three, and six months after surgery to monitor plasma ctDNA dynamically. During the study, participants will undergo regular assessments including blood draws for ctDNA analysis. Researchers will measure outcomes such as the patients two-year progression-free survival and ctDNA clearance rate at six months. The study aims to follow participants over a two-year period to evaluate treatment effects and safety.

Researchers are evaluating the safety and effectiveness of a new drug delivery method using dexamethasone-loaded exosomes compared to standard intratympanic dexamethasone and exosome vehicle alone in adults with sudden sensorineural hearing loss SSNHL. This condition involves rapid hearing loss of 30 decibels or more over three frequencies within 72 hours, with causes often unknown but possibly related to infections, immune responses, or blood flow issues in the ear. The study aims to improve drug delivery to the inner ear and reduce systemic side effects. The trial includes three treatment groups one receiving standard dexamethasone injections into the middle ear, another receiving exosomes alone, and the third receiving exosomes loaded with dexamethasone. These treatments are given as a single course through intratympanic administration. The researchers will assess how well the treatments improve hearing and how the drugs distribute within the ear, using advanced imaging and hearing tests over several weeks. Participants will undergo hearing assessments including pure-tone average tests, auditory brainstem response, and otoacoustic emissions at baseline and follow-up visits at 1, 4, and 12 weeks after treatment. Safety and tolerability will be closely monitored. The main measurement is the change in hearing levels four weeks after treatment. The study will last up to six months for each participant, with detailed evaluations to understand the drugs effects and safety profile throughout this period.

Researchers are investigating ways to improve the detection and study of circulating tumor cells CTCs in patients with metastatic prostate cancer. This observational study compares two blood sampling methods, leukapheresis and peripheral blood collection, to understand their advantages and disadvantages for diagnosis and treatment. The study also aims to explore tumor biology and the processes behind prostate cancer invasion and metastasis. Participants will undergo two procedures a 7.5 mL peripheral blood draw and leukapheresis, which is a device-based method that selectively separates leukocytes and enriches CTCs by processing multiple blood volumes without significantly changing the patients blood volume. Leukapheresis takes about 2 hours and is routinely performed in clinical settings. Throughout the study, researchers will measure the number of CTCs obtained by each method within 24 hours after sampling. Participants will be assessed for their general health, blood, liver, and kidney function. The study will monitor participants until completion in 2028, focusing on comparing the sampling methods and gathering information on tumor characteristics and disease mechanisms.

This research aims to collect various human biological samples such as blood, urine, body fluids, skin swabs, and skin biopsies to support medical studies conducted by the National Institute of Allergy and Infectious Diseases Vaccine Research Center. These samples help researchers study diseases including HIV and hepatitis, understand immune responses to infections or vaccinations, and assist in vaccine development. The study is observational and involves volunteers aged 3 years and older. Participants may provide samples through standard blood draws or apheresis, a process that collects larger amounts of blood components by separating them and returning the rest to the body. The apheresis procedure lasts about 1 to 3 hours and is performed with participants resting on a recliner. Depending on the specific research needs, volunteers may donate samples once or multiple times during their enrollment, which lasts for one year and can be extended. Throughout the study, participants will provide specimens that are stored and used for various laboratory research projects related to immunity and vaccine development. Personal information linked to the samples is limited to a participant ID to maintain privacy. The study does not have specific endpoints but focuses on collecting samples safely and according to good clinical practices. Participants may be asked to provide proof of identity and complete informed consent, and their health status will be assessed to ensure safe participation.

Researchers are studying the effects of adjuvant radiotherapy on patients with non-metastatic breast cancer, focusing on circulating epithelial tumor cells CETCs in the blood and their immunohistochemical features. The study compares younger high-risk premenopausal and older low-risk postmenopausal patients to explore how age influences these cells and immune system markers. The goal is to find potential prognostic biomarkers by analyzing molecular and immune changes during treatment. The study involves patients receiving guideline-based adjuvant radiotherapy after tumor removal, with some also having neoadjuvant or adjuvant chemotherapy. Blood samples are collected at multiple time points during therapy to detect, isolate, and genetically characterize CETCs. Immunophenotyping of peripheral blood mononuclear cells is performed, and tumor tissue is analyzed for immunohistochemical features and tumor-infiltrating lymphocytes. The study also examines therapy-resistant tumor cell phenotypes through in vitro cultivation. Participants will have blood drawn and tissue samples analyzed to track changes in CETCs and immune markers over two years. The study evaluates the relationship between these markers and tumor characteristics, with follow-up monitoring for recurrence-free survival over three years. This research aims to better understand molecular and immune responses to radiotherapy without altering the patients treatment plans.

Researchers are evaluating a combination of two investigational drugs, sacituzumab govitecan and atezolizumab, as a treatment for patients with triple negative breast cancer who have residual cancer in the breast or lymph nodes and circulating tumor DNA in their blood. This phase II trial aims to determine if these drugs work together to prevent cancer recurrence after prior treatments including chemotherapy and surgery. The study includes patients with HER2-negative, hormone receptor-negative breast cancer who have completed neoadjuvant chemotherapy and locoregional therapy. Participants will receive the combination therapy for 18 weeks, consisting of six cycles of treatment. Atezolizumab is given intravenously on day 1 of each 21-day cycle, while sacituzumab govitecan is given intravenously on days 1 and 8 of each cycle. After completing treatment, participants will be followed every six months for up to three years to monitor their health and cancer status. During the study, participants will undergo screening to confirm eligibility, laboratory tests, stool collection, and regular follow-up visits. Researchers will measure the rate at which circulating tumor DNA becomes undetectable after treatment cycles, as well as track treatment-related side effects and long-term outcomes such as disease-free survival and overall survival over three years. This comprehensive monitoring aims to assess both the immediate and lasting effects of the drug combination.

Researchers are conducting a large observational study to evaluate new biochemical and electrocardiographic markers, both alone and combined with the standard 12-lead exercise ECG, to detect exercise-induced myocardial ischemia, which is linked to coronary artery disease CAD. The study also aims to assess these markers ability to predict the risk of cardiovascular death and heart attacks over long-term follow-up. This approach is important since current imaging techniques for CAD detection involve risks, are costly, and mainly provide anatomical rather than functional information. The study involves enrolling about 4200 patients suspected of having exercise-induced myocardial ischemia who are referred for rest or exercise myocardial perfusion SPECT testing. Before the exercise stress test, venous blood samples will be collected to measure various biochemical markers possibly related to ischemia, such as cardiac troponins, B-type natriuretic peptide, IL-6, and cardiac microRNA. Additionally, continuous ECG recordings will be obtained before, during, and after exercise using advanced devices and processing methods to identify new electronic markers. All tests will be analyzed without knowledge of patient clinical data to ensure unbiased results. Participants will undergo the exercise stress testing and blood sampling at baseline. Follow-up will be conducted at 1, 2, 5, and 8 years to record clinical outcomes including death, cardiovascular death, heart attacks, and coronary revascularization. The research team will evaluate the diagnostic usefulness of the new biochemical and ECG signatures at baseline and monitor long-term event-free survival. This comprehensive approach aims to improve non-invasive detection and risk assessment for patients with suspected CAD, potentially simplifying current testing and reducing exposure to radiation and contrast agents.

Breast cancer, particularly the hormone receptor-positive HR, HER2-negative subtype, accounts for about 70% of cases and remains a major cause of illness and death worldwide. This trial evaluates the use of circulating tumor DNA ctDNA to guide personalized treatment, aiming to reduce the need for toxic chemotherapy in early-stage, high-risk breast cancer patients. The study focuses on the impact of neoadjuvant therapy combining CDK46 inhibitors with endocrine therapy and explores whether ctDNA can help safely adjust post-surgery treatment. Participants receive 4 cycles of neoadjuvant therapy with a CDK46 inhibitor plus endocrine therapy. After surgery, treatment is tailored based on ctDNA status those who are ctDNA-negative continue CDK46 inhibitor with endocrine therapy for 2 to 3 years, while ctDNA-positive patients may receive optional adjuvant chemotherapy followed by the same CDK46 inhibitor and endocrine therapy. Premenopausal women additionally receive ovarian suppression using LHRH agonists. Some patients are randomly assigned to receive chemotherapy or not based on their ctDNA results and tumor markers. During the study, participants undergo ctDNA testing to monitor treatment response, along with assessments of tumor response, including pathological complete response and markers like Ki67. Researchers track safety by recording treatment-related adverse events and measure long-term outcomes such as event-free survival over three years. The study duration includes neoadjuvant therapy, surgery, and extended follow-up with personalized treatment adjustments based on ctDNA findings.