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Biomarker clinical trials

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NCT ID: NCT05764356 Not yet recruiting - Bleeding Clinical Trials

Imapct of bioMarkers on Pharmacodynamics and Bleeding Risk of Direct Oral AntiCoagulants and Ticagrelor Study II

Start date: March 2023
Phase:
Study type: Observational

Individual differences in drug efficacy and adverse reactions are common in the clinical application of drugs. Individual differences are caused by many factors, among which genetic factors account for more than 20%. Novel oral anticoagulant drugs (NOACs, including rivaroxaban, apixaban, edoxaban, dabigatran, etc.) and novel antiplatelet drug ticagrelor have the advantages of convenient use and no need for monitoring. But novel oral antithrombotic drugs also increase the risk of bleeding, and there is currently a lack of effective antagonists when antithrombosis is excessive or emergency surgery is required. At present, there are few studies on the causes of individual differences in novel antithrombotic drugs, and there is a lack of predictable biomarkers or drug genotypes, especially in China. Therefore, on the basis of previous studies on NOACs and ticagrelor individualized medication cohorts, this study plans to establish a validation cohort for novel antithrombotic drugs bleeding related biomarkers, conduct multi-omics testing and long-term follow-up, and explore markers related to pharmacodynamics of antithrombotic drugs, adverse bleeding reactions and clinical outcomes.

NCT ID: NCT05752890 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

A Novel Biomarker for Response and Prognosis of HBV-related Hepatocellular Carcinoma

Start date: March 1, 2023
Phase:
Study type: Observational [Patient Registry]

The investigators will first use our previously collected serum samples and surgical/biopsied tissues from HBV-related HCC patients undergoing radiotherapy. The consistency of junctional clones by Capture NGS needs to be tested between both pre- and post-RT serums, and serial changes in copy numbers of vh-DNA by ddPCR are quantified in the representative cases. The same junction clones from pre-post-RT serums and surgical tissues will be confirmed and the copy number changes of vh-DNA be correlated with RT response and disease-control status. The investigators plan to identify HBV integrations by Capture NGS and quantify the specific vh-DNA by ddPCR as personalized biomarkers from the same-patient serum samples. The investigators will further correlate clinical response and recurrence/metastasis with serial changes of vh-DNA copy numbers. The investigators have been prospectively collecting plasma samples from HBV-related HCC patients before/after RT, at 1, 4, 7 months, and at recurrence/metastasis. The investigators plan to confirm the viable role of pre-/post-RT changes of plasma vh-DNA copies of the same junction clone in post-RT response and prognosis. Moreover, The investigators will explore the recurrent/metastatic tumors arising from the original or a de novo one by identifying their clonality with HBV integration patterns. The true value of this novel HBV chimera vh-DNA will be revealed. The results will also support the consolidative use of personalized vh-DNA for earlier evaluating treatment response after RT, for post-RT disease monitoring, and for differentiating clonality at recurrence to design future clinical trial on combinational treatment.

NCT ID: NCT05428410 Not yet recruiting - Biomarker Clinical Trials

Study on Biomarkers to Predict the Efficacy of IL-4R Monoclonal Antibody for Chronic Rhino-sinusitis With Polyps

Start date: June 17, 2022
Phase:
Study type: Observational

The prevalence of chronic rhinosinusitis in China is about 8%, and some patients still suffer from recurrences after surgery and drug treatment. Monoclonal antibody is considered to be a new drug strategy that can significantly improve the control rate of such patients, but there is a lack of markers to guide the selection of monoclonal antibodies. The price of monoclonal antibody is expensive, which calls for screening markers for predicting the efficacy of monoclonal antibody and precisely implementing this treatment strategy. In addition, it can also improve the quality of life of patients and reduce the social and economic burden. Beijing Tongren Hospital, Capital Medical University recently completed a randomized, double-blind, placebo-controlled, phase II clinical study which included multiple subcutaneous administration of CM310 recombinant humanized monoclonal antibody injection in patients with chronic sinusitis and nasal polyps to evaluate the efficacy and safety as well as the pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy(NCT04805398). The therapeutic target of CM310 recombinant humanized monoclonal antibody injection is IL-4R. The unblinded data showed significant differences in the efficacy of the subjects and we started the investigator-initiate trial (IIT) study aiming at investigating the remaining samples of the project and carrying out a biomarker study to screen and predict the efficacy of IL-4R monoclonal antibody.

NCT ID: NCT04966000 Not yet recruiting - Stroke Clinical Trials

Neurobiomarker for Prism Adaptation Treatment Response

Start date: January 2024
Phase: N/A
Study type: Interventional

Preliminary data will be collected about which individuals with spatial neglect from right hemisphere stroke (aiming vs perceptual neglect) improve with Prism Adaptation Training and if there is a particular pattern of damage in the brain that predicts both the type of neglect experienced and whether neglect is improved following Prism Adaptation Training

NCT ID: NCT03739892 Not yet recruiting - Stroke Clinical Trials

Biomarkers to Predict Gain From Therapy in Motor Stroke

GAIN
Start date: November 2018
Phase: N/A
Study type: Interventional

The aim is to determine predictors of treatment response, i.e gain from rehabilitation training, in post stroke upper limb deficits. The investigators will like to answer the following question: "What is this patient's potential for recovery, given his profile?" The investigators propose to conduct a longitudinal physiopathological study on the stroke patients with motor deficits who entered the rehab center of Pitié Salpêtrière hospital. The investigators will benefit from the organization, which is already in place (clinical asssessments and training) to add MRI, TMS and EEG recordings, as well as genotype analysis before the training offered in the rehabilitation unit. The investigators will repeat these assessments after the training (immeadiately and 6 weeks after).

NCT ID: NCT03390946 Not yet recruiting - Osteosarcoma Clinical Trials

Feasibility Study of Interval Compressed Regimen Using Four-drugs for Osteosarcoma

Start date: February 1, 2018
Phase: Phase 2
Study type: Interventional

The aim of the study is to test the feasibility of four-drug, interval-compressed regimen in osteosarcoma. Primary objective is to explore the toxicity and mortality related to treatment. Secondary objectives are to examine tumor necrosis rates after neoadjuvant chemotherapy, and to evaluate the usefulness of circulating cell-free DNA, survivin, or transforming growth factor-beta1 levels as well as programmed cell death ligand 1 expression in tumor specimen as a predictive or prognostic biomarker in osteosarcoma patients.

NCT ID: NCT02931136 Not yet recruiting - Clinical trials for Mild Cognitive Impairment

Early Diagnosis and Early Treatment of Alzheimer's Disease Based on Senile Plaque Imaging

Start date: November 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is based on the Flutemetamol-PET senile plaque imaging to investigate the peripheral blood biochemical and brain MRI imaging biomarkers and to research completely independent intellectual property rights neuropsychological test tool for the MCI due to AD. At the same time, the investigators will study the efficacy and safety of early treatment of MCI due to AD by Huperzine A in 52 weeks.