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NCT ID: NCT06469229 Not yet recruiting - Bladder Cancer Clinical Trials

Performance Evaluation of Urine DNA Methylation Testing for the Detection of Urothelial Carcinoma in Patients With Hematuria

Start date: July 1, 2024
Phase:
Study type: Observational

Background Urothelial carcinoma (UC) is the most common malignancy of the urinary system. Hematuria is a significant clinical manifestation of UC, often diagnosed through invasive procedures. Urine DNA methylation testing is a promising non-invasive method for early UC detection. Objectives To evaluate the sensitivity and specificity of urine DNA methylation testing for detecting UC in patients with hematuria, using standard clinical and pathological diagnoses as the gold standard. We also aim to investigate the association between preoperative urine DNA methylation status and prognosis in UC patients. For non-UC patients: Follow up for one year to assess the risk of UC development based on preoperative urine DNA methylation status. Sample Size Calculation Expected sensitivity: 86% Expected specificity: 90% Significance level (Alpha): 0.05 Total participants needed: 1053 (adjusted for 5% dropout rate, 1109 participants will be recruited). Study Procedure Enrollment and Sample Collection: Screen patients, obtain consent, collect urine samples. Blinding and Testing: Blinded sample processing and DNA methylation testing. Unblinding and Analysis: Statistical analysis of sensitivity and specificity. Reporting: Compilation and consolidation of clinical trial reports. We anticipate that urine DNA methylation testing will show high sensitivity and specificity for UC diagnosis in patients with hematuria, providing valuable non-invasive diagnostic information and improving patient outcomes.

NCT ID: NCT06469060 Not yet recruiting - Esophageal Cancer Clinical Trials

Neoadjuvant Immunochemotherapy for Adenocarcinoma of the Esophagogastric Junction

TRACE
Start date: June 19, 2024
Phase: Phase 2
Study type: Interventional

The investigators will conduct a prospective phase 2 study to evaluate the efficacy and safety of a modified neoadjuvant immunotherapy plus chemotherapy (one cycle of Tislelizumab monotherapy followed by four cycles of Tislelizumab plus Docetaxel, Oxaliplatin and Capecitabine) in patients with locally advanced resectable adenocarcinoma of the esophagogastric junction (AEG).

NCT ID: NCT06469047 Not yet recruiting - AML Clinical Trials

Relationship Between Serum N/OFQ and Acute Myeloid Cell Leukemia

RBSNAAMCL
Start date: June 20, 2024
Phase:
Study type: Observational

Patients diagnosed with acute myeloid leukemia in the Second Hospital of Shanxi Medical University were selected and divided into the newly diagnosed group, the relapsed group, the complete remission group as the experimental group, and the healthy physical examination subjects as the control group. The relationship between IL-1β, catecholamine and norkephalin in peripheral blood of the experimental group and the control group was observed. According to the literature, the experimental group was significantly higher than the control group. In the experimental group, the newly diagnosed group was higher than the relapse group, and the relapse group was higher than the complete remission group, and the correlation was positive, and the difference was statistically significant.

NCT ID: NCT06469008 Not yet recruiting - Solid Tumor Clinical Trials

A Study of BL-B16D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

Start date: July 2024
Phase: Phase 1
Study type: Interventional

This study is an open, multicenter, increasing dose and dose extension nonrandomized phase I clinical study to evaluate the safety, tolerance, pharmacokinetic characteristics and preliminary effectiveness of BL-B16D1 in recurrent or metastatic head and neck squamous cell carcinomas and other solid tumors.

NCT ID: NCT06468956 Not yet recruiting - Clinical trials for Moderate to Severe Atopic Dermatitis

Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis

Start date: June 2024
Phase: Phase 3
Study type: Interventional

This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with atopic dermatitis.

NCT ID: NCT06468683 Not yet recruiting - Lupus Erythematosis Clinical Trials

F01 in the Treatment of Moderate-to-severe Refractory Systemic Lupus Erythematosus

Start date: June 15, 2024
Phase: Phase 1
Study type: Interventional

This is a phase I clinical study to evaluate the safety , pharmacokinetic profile, and preliminary efficacy of F01 in patients with moderate-to-severe refractory systemic lupus erythematosus.

NCT ID: NCT06468436 Not yet recruiting - Delirium Clinical Trials

Dexmedetomidine-Esketamine Combination for Sedation and Analgesia in ICU Patients

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

Patients with mechanical ventilation in the intensive care unit (ICU) often develop anxiety and agitation, sleep distuebances, and delirium. Delirium occurrence is associated with worse early and long-term outcomes. Dexmedetomidine and ketamine are recommended for sedation and analgesia in ICU patients, but each may induce side effects. The sedative effects of dexmedetomidine can help mitigate the psychiatric side effects of esketamine. Recent studies showed that dexmedetomidine-esketamine combination improved analgesia and sleep quality without increasing psychiatric side effects. This trial is designed to test the hypothesis that dexmedetomidine-esketamine combination for sedation and analgesia in ICU patients with mechanical ventilation may reduce delirium and improve respiratory recovery.

NCT ID: NCT06468358 Not yet recruiting - Solid Tumor Clinical Trials

A Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors

TRIGGERCD8
Start date: June 20, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase Ib/II, open, dose-escalation and expansion study of an anti-PD1/TIM3 bispecific antibody,LB1410 in combination with an anti-Claudin18.2/IL-10 fusion protein, LB4330 in patients with advanced or metastatic solid tumors.

NCT ID: NCT06468280 Not yet recruiting - Gastric Cancer Clinical Trials

Synergistic Effects of PD-1 Antibody and Chemotherapy Followed by Surgery in Limited-metastatic G/GEJ Adenocarcinoma

ROSETTE
Start date: July 2024
Phase: Phase 2
Study type: Interventional

The objective of this trial is to compare the efficacy of a comprehensive treatment strategy involving PD-1 monoclonal antibody combined with XELOX chemotherapy followed by radical resection surgery, versus simple systemic treatment in patients with limited distant metastasis of gastric adenocarcinoma/gastroesophageal junction adenocarcinoma. After enrollment and successful screening, eligible participants will be randomized in a 1:1 ratio into a surgical arm and a non-surgical arm, and will undergo the following treatment: Surgical Arm: 1. Phase 1 Systemic Therapy: Administration of PD-1 monoclonal antibody in combination with XELOX chemotherapy for cycles 1-4. 2. Surgery: Performing a D2 standard gastrectomy for gastric cancer and radical resection of resectable metastatic lesions. 3. Phase 2 Systemic Therapy: Continuation of PD-1 monoclonal antibody combined with XELOX chemotherapy for cycles 5-8, followed by maintenance therapy with PD-1 monoclonal antibody and capecitabine monotherapy from the 9th cycle until two years post-enrollment. 4. During phase 2 systemic therapy, concurrent local treatments for unresected metastatic lesions are permitted, including radiotherapy, interventional embolization, radiofrequency ablation, and hyperthermic intraperitoneal chemotherapy (HIPEC). Non-Surgical Arm: 1. Phase 1 Systemic Therapy: Administration of PD-1 monoclonal antibody in combination with XELOX chemotherapy for cycles 1-4. 2. Phase 2 Systemic Therapy: Continuation of PD-1 monoclonal antibody combined with XELOX chemotherapy for cycles 5-8, followed by maintenance therapy with PD-1 monoclonal antibody and capecitabine monotherapy from the 9th cycle until two years post-enrollment.

NCT ID: NCT06467773 Not yet recruiting - Clinical trials for Central Nervous System Diseases

TSPO-PET/MRI in Surveillance of Neuroinflammation in the Central Nervous System

Start date: June 2024
Phase:
Study type: Observational

Central Nervous System (CNS) inflammation is an immune response activated in the brain and spinal cord by microglial cells and astrocytes, commonly occurring under conditions such as CNS ischemia, autoimmunity, infection, toxins, and trauma. Microglial cells, as the innate immune cells of the CNS, are responsible for driving the inflammatory response and play a crucial role in sensing environmental changes, responding to harmful stimuli, and engulfing dead neurons. They also present antigens to T lymphocytes, mediating interactions between the peripheral immune system and the CNS. Factors released by neuronal cells can either promote or inhibit inflammation, and monitoring the level of inflammation driven by microglial cells is essential for the diagnosis and treatment of CNS diseases. MRI is the primary imaging method for CNS inflammation, but it can be challenging to diagnose. PET/MR, a technology that integrates PET and MR imaging, provides high-quality diagnostic images and is valuable for the early detection, diagnosis, and assessment of CNS diseases. The radioactive ligand 18F-DPA-714 PET, targeting the translocation protein (TSPO), can visualize activated microglial cells, which may have a gain effect in detecting active CNS inflammation. This study aims to explore the application of 18F-DPA-714 PET/MR in the early diagnosis, treatment evaluation, and prognosis of CNS inflammation.