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Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma

NCT06257017 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-04

No results posted yet for this study

Summary

Urothelial carcinomas are one of the most commonly diagnosed cancers worldwide. Postoperative patients carry a poor prognosis with an estimated five-year disease-specific survival rate of 50%. To improve overall survival and reduce the recurrent risk, chemotherapy is recommended as a standard of care. However, currently in Hong Kong, neoadjuvant (preoperational) chemotherapy and adjuvant (postoperative) chemotherapy are not commonly or regularly provided due to the concern of the potential harm from both physicians and patients. Recently, genetic signature from circulating tumor DNA (ctDNA) is emerging as a pivotal biomarker for detecting caner in early stage and molecular residual disease (MRD). With strengths of non-invasive and superior sensitivity, ctDNA is hopefully to serve as a cancer-agnostic surrogate analyte for risk stratification of tumor recurrence, thereby guiding individually tailored treatment. Therefore, this study is proposed to exploratively assess the benefit of ctDNA-guided approach for postoperative adjuvant therapy.

Conditions

  • Muscle Invasive Bladder Urothelial Carcinoma
  • Muscle-Invasive Bladder Carcinoma

Interventions

DRUG

gemcitabine

1,000 mg/m2 intravenous gemcitabine on day 1 and day 8

DRUG

Cisplatin

70 mg/m2 intravenous cisplatin (split into 2 doses on day 1 and day 8)

Sponsors & Collaborators

  • Pamela Youde Nethersole Eastern Hospital

    collaborator OTHER

  • Queen Mary Hospital, Hong Kong

    collaborator OTHER

  • Yung NA

    lead OTHER

Principal Investigators

  • Yung Na, PHD · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-02
Primary Completion
2025-09-30
Completion
2025-12-30

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06257017 on ClinicalTrials.gov