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Application of Multi-Component Liquid Biopsy (ctDNA, utDNA, Exosomes, and Protein Biomarkers in Blood and Urine) for Auxiliary Diagnosis, Therapeutic Response Evaluation, and Recurrence Monitoring in Urothelial Carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-Component Liquid Biopsy for Urothelial Carcinoma | Diagnostic Test | This intervention is a non-invasive, multi-component liquid biopsy assay specifically designed for patients with urothelial carcinoma (including bladder cancer and upper tract urothelial carcinoma). It integrates multiple tumor-derived analytes from paired blood and urine samples: circulating cell-free DNA (cfDNA)/circulating tumor DNA (ctDNA) from peripheral blood plasma, urinary tumor DNA (utDNA)/cell-free DNA from urine, exosomal RNAs (e.g., miRNAs, lncRNAs) and proteins from urine-derived exosomes, and selected tumor-associated proteins. Serial sampling is performed at key clinical time points to enable longitudinal assessment:
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Concordance | The proportion of patients in whom the molecular alterations (e.g., somatic mutations in key genes such as FGFR3, TP53, TERT promoter, PLEKHS1; methylation signatures; or multi-omic features) detected in multi-component liquid biopsy (blood ctDNA/cfDNA + urine utDNA/exosomal components) match those identified in the reference tissue biopsy or surgical specimen (gold standard). | At baseline (pre-treatment/diagnosis confirmation) or within the diagnostic window. |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic concordance during treatment/follow-up | The degree of agreement between longitudinal changes in multi-component liquid biopsy markers (primarily variant allele frequency [VAF] of key somatic mutations in ctDNA from blood and utDNA from urine, as well as exosomal RNA/protein levels where applicable) and clinical/radiological/pathological response endpoints | Serial assessments at baseline, during treatment (e.g., after each cycle or at predefined intervals such as 4-8 weeks), post-treatment (e.g., 3, 6, 12 months, and annually thereafter), up to 24-36 months or until progression/recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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This observational cohort study enrolls adult patients (≥18 years) with suspected or histologically confirmed urothelial carcinoma (UC), including non-muscle-invasive bladder cancer (NMIBC), muscle-invasive bladder cancer (MIBC), metastatic urothelial carcinoma, and upper tract urothelial carcinoma (UTUC) of the renal pelvis or ureter. Participants are recruited from urology/oncology clinics at participating centers.
The study population consists: Patients with clinical suspicion of UC and patients with pathologically confirmed UC at any stage.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hailong Hu, MD | Contact | +8613662096232 | huhailong@tmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second hospital of Tianjin Medical University | Recruiting | Tianjin | 300000 | China |
Individual participant data (IPD) will not be shared. The primary reason is to protect participant privacy and confidentiality, as the study involves sensitive clinical and molecular data (e.g., ctDNA/utDNA profiles, exosomal components) from patients with urothelial carcinoma. De-identification alone may not fully eliminate re-identification risks in this context, particularly given the rarity of certain genomic alterations and potential linkage to clinical records. Additionally, the informed consent and institutional ethics committee approval did not include provisions for broad secondary use or sharing of raw individual-level data beyond the study team. Results will be disseminated through peer-reviewed publications and aggregate summaries to maintain transparency while prioritizing participant protection.
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Paired peripheral blood plasma and urine samples will be retained from participants with urothelial carcinoma. These include:
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| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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