Biomarkers

Researchers are studying how bite force and bone turnover markers change during the retention phase after orthodontic treatment in patients with different vertical facial growth patterns. The study compares patients with vertical (hyperdivergent) and horizontal (hypodivergent) craniofacial growth to understand relapse and bone remodeling processes over a 12-month retention period. This prospective clinical trial aims to provide insights into maintaining teeth alignment using retention appliances after fixed orthodontic treatment. The trial includes two groups of patients who have completed fixed orthodontic treatment and are ready for retainer delivery. Group 1 consists of patients with vertical growth patterns (FMA 26° or more), while Group 2 includes those with horizontal growth patterns (FMA 24° or less). Both groups will receive a Begg's retainer formed conventionally and delivered within 24 hours of debonding. Changes in bite force will be measured using a bite force device, and bone turnover markers CTX (bone resorption) and BALP (bone formation) will be assessed using ELISA at baseline and at 1, 3, 6, and 12 months after retainer delivery. Participants will undergo bite force measurements and biomarker testing at five timepoints during the 12 months retention phase: at retainer delivery, then after 1, 3, 6, and 12 months. Data on bone turnover markers and bite force changes will be collected and compared between the two groups. The study includes monitoring of functional occlusion, oral hygiene, and retainer compliance. The total participation time spans 12 months, during which researchers will assess both clinical and biochemical indicators of bone remodeling and bite function after orthodontic treatment.

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 test's clinical utility.

Researchers are evaluating a personalized self-DC vaccine that targets neo-antigens (Neo-DC vaccine) for treating advanced solid tumors, including head and neck cancer and certain types of non-small cell lung cancer without driver gene mutations. This study aims to explore the dose-limiting toxicity and identify the recommended dose for future Neo-DC vaccine research. About 9 patients will be enrolled, following a 3 plus 3 dose escalation design with two dose levels. Participants will receive infusions of the Neo-DC vaccine at either a lower dose (1 x 10^7 cells per infusion) or a higher dose (5 x 10^7 cells per infusion) given every 7 days. Four infusions make up one treatment cycle. If clinical benefit or certain immune responses are observed, treatment cycles may continue until four administrations are completed, disease progression occurs, new anti-tumor treatments begin, or treatment is stopped for other reasons. Dose-limiting toxicity is monitored within 28 days after the first infusion. During the study, participants will be monitored for adverse events within 28 days of the first vaccine infusion. Researchers will also assess the objective response rate over up to 2 years and observe dose-limiting toxicities in the same 28-day window. Participants must complete all study procedures, including blood collections and tumor assessments based on RECIST 1.1 standards. The total participation duration varies depending on treatment continuation and disease status.

Researchers are investigating the relationship between gut microbiota dysfunction and Alzheimer's disease (AD), focusing on how gut-derived short-chain fatty acids (SCFAs) may influence brain function through the "gut microbiota-SCFAs-brain networks" pathway. This observational study will explore differences in SCFAs among people across the AD spectrum, including cognitively normal individuals, those with subjective cognitive decline (SCD), mild cognitive impairment (MCI), and AD dementia. The project aims to clarify the interactions between gut microbiome, metabolites, and brain changes using high-throughput metabolomics and multi-modal MRI techniques. Participants will be grouped into four categories: cognitively normal, SCD, MCI, and AD dementia. The study involves collecting multi-omics data, including gut microbiome analysis, metabolomics, and neuroimaging, to establish a diagnostic model for SCD due to preclinical AD using machine learning methods. The study spans five years, during which gut microbiome changes, SCFAs levels, and multi-omics biomarkers related to cognitive impairment conversion will be monitored. Participants will undergo cognitive tests and brain imaging scans, along with gut microbiome and metabolite sample collection. Researchers will assess the interaction mechanisms of the gut microbiota-SCFAs-brain networks over five years. The study includes both healthy volunteers and patients aged 60 to 80. Outcome measures focus on changes in gut microbiome, SCFAs, and biomarkers linked to cognitive decline, with long-term follow-up to better understand the disease progression and its early detection.

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 focuses on kidney transplant patients to collect blood samples and clinical data for developing a non-invasive test that detects donor-derived cell-free DNA (dd-cfDNA) to assess the condition of transplanted kidneys. The study is prospective and multicenter, involving participants who have had a kidney transplant and are undergoing an indication biopsy. The goal is to improve monitoring of the transplanted organ's status. Participants will provide whole blood samples at the time of their indication biopsy, before the biopsy procedure itself. Additionally, leftover de-identified retrospective genomic DNA (gDNA) samples from the kidney donors will be collected for paired analysis. This approach helps researchers study dd-cfDNA in a real-world transplant population. Participants will be involved through blood sample collection and clinical data gathering during their biopsy visits. Researchers will monitor the detection of donor-derived cell-free DNA in whole blood over an 18-month period. The study involves no investigational treatments, focusing on observation and sample analysis. Participation duration and follow-up details align with the biopsy schedule and sample collection requirements.

Researchers are studying whether a combination of two drugs, fruquintinib and tislelizumab, can help control colorectal cancer in patients who have completed treatment but still show signs of minimal residual disease (MRD) through positive ctDNA tests. This phase 2 trial focuses on patients with microsatellite stable colorectal adenocarcinoma who have finished curative treatments including chemotherapy. The study aims to measure how well the treatment clears ctDNA at 3 and 6 months, as well as to assess disease-free survival, overall survival, and safety. Participants will receive treatment with fruquintinib taken orally and tislelizumab given intravenously. The study does not include randomization or placebo groups; all participants receive the combination therapy. The treatment period and dosing schedules are designed to evaluate the effects on MRD as detected by the Signatera assay. The trial includes careful monitoring of organ function and blood counts to ensure participant safety. Throughout the study, participants will undergo regular ctDNA testing to monitor minimal residual disease status, along with assessments for disease progression and survival. Safety and adverse events will be tracked for about one year from the start of treatment. Participants must be able to provide informed consent and will be closely observed for treatment tolerability and effectiveness. The study will continue until April 2028, allowing long-term follow-up on outcomes and safety.

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 drug's effects and safety profile throughout this period.

Researchers are evaluating the effects of a dietary supplement on blood-based nutritional biomarkers in healthy children aged 4 to 15 years. This pilot clinical study aims to gather preliminary data on how the supplement influences serum levels of vitamin D, vitamin B12, folate, omega-3 fatty acids, and other blood count parameters. The study is conducted by SF Research Institute, Inc. and focuses on understanding nutritional status through biomarker changes. The study involves a single group of participants who will take an investigational gummy dietary supplement called Kids Multi & Omegas. Children will be instructed to take two gummies once daily, with or without food, for a total of 4 weeks. Blood samples will be collected at the start and end of the study to assess changes in selected serum nutritional biomarkers. Participants will also undergo measurements of height, weight, and body mass index, and complete a socioeconomic questionnaire. Participants will attend two clinic visits: one for screening and baseline assessments and another at the end of the 4-week supplementation period. During the study, children or their caregivers will keep a daily diary recording supplement intake, medication use, and any side effects. Researchers will review compliance, collect blood samples, and assess changes in nutritional biomarkers and physical measurements. The total study duration for each participant is approximately 4 weeks.