NCT07532356

Integrating Tumor Genomics and Urinary Exosomal Proteomics to Establish a Multi-Layer Biomarker Framework for Early Risk Stratification and Post-Treatment Surveillance in Fresh Thyroid Cancer Patients

Not yet recruiting Last updated 15 April 2026

What this trial tests

trial in Genomics in 100 participants. Not yet recruiting.

Timeline

1 August 2026

Primary endpoint
31 July 2030

31 July 2031

Quick facts

Lead sponsor	National Taiwan University Hospital
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	100
Start date	1 August 2026
Primary completion	31 July 2030
Estimated completion	31 July 2031

Conditions studied

• Genomics — all drugs for Genomics →
• Thyroid Cancer — all drugs for Thyroid Cancer →
• NGS — all drugs for NGS →

Sponsor

National Taiwan University Hospital

Who can join

Adults 18 to 80, any sex, with Genomics or Thyroid Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Thyroid cancer is the most common endocrine malignancy, and although differentiated thyroid cancer (DTC) generally confers favorable outcomes, 10-20% of patients still face substantial postoperative risks, including local recurrence, distant metastasis, and inadequate response to radioactive iodine therapy. Current risk stratification, largely based on tumor size, lymph node involvement, and histopathology, fails to adequately represent tumor heterogeneity and evolutionary changes, potentially resulting in both overtreatment and undertreatment. Next-generation sequencing (NGS) has revealed a stepwise accumulation of genomic alterations from early driver mutations (e.g., BRAF, RAS, RET/PTC, PAX8-PPARG) to late-stage progression events (e.g., TERT promoter, TP53, PI3K/AKT/mTOR), while metastatic lesions often harbor high-risk mutations absent in primary tumors, underscoring the limitations of single-time-point tissue sampling. Furthermore, serum thyroglobulin (Tg) surveillance is hindered in patients with anti-Tg antibodies. Extracellular vesicles (EVs), particularly those obtained from urine, provide a compelling liquid biopsy modality due to their non-invasiveness, repeatability, and reduced interference by abundant serum proteins. The investigators' previous findings demonstrate that urinary exosomal peptides-including U-Ex Tg, ANXA2, TIMP, and Angiopoietin-1-correlate with malignancy, capsular invasion, and nodal metastasis, and exhibit dynamic postoperative variation, suggesting their utility in detecting molecular residual disease.

This prospective study will recruit 100 fresh thyroid cancer cases and integrate tumor genomic profiling, urinary exosomal proteomics via LC-MRM/MS, and clinical phenotype assessment-including nodal involvement, subsequent therapies, and long-term outcomes-to delineate causal links between genomic drivers, proteomic execution signals, and clinical progression. The overarching aim is to establish an early risk-stratification and molecular recurrence-alerting model capable of identifying high-risk trajectories earlier than conventional approaches, thereby enhancing surveillance precision and enabling timely intervention. This multi-layered biomarker framework holds strong potential to redefine postoperative monitoring standards and advance the clinical and policy implementation of precision medicine in thyroid cancer.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.