Actively Recruiting
Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma
Led by Yung NA · Updated on 2025-04-04
20
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
Y
Yung NA
Lead Sponsor
P
Pamela Youde Nethersole Eastern Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 1 or less
- Undergoing radical cystectomy with lymph node dissection or nephroureterectomy
- Histologically confirmed muscle invasive urothelial carcinoma, mainly transitional cell carcinoma
- Tumor classification pT2-4a N0-2M0
- No microscopic or gross residual tumor after surgery (R0 resection) and no metastasis confirmed by CT or MRI within 4 weeks before enrollment
- Adequate blood counts and organ function within 28 days before first study treatment
- Able to understand and provide written informed consent and agree to study procedures
You will not qualify if you...
- Received any approved anti-cancer treatment within 3 weeks before enrollment
- Participated in another therapeutic clinical trial within 28 days before enrollment
- Had other malignancies within 5 years before enrollment
- Have conditions contraindicating chemotherapy, including creatinine clearance below 50 mL/min, hearing impairment, or poor marrow function
- History of allergic or hypersensitivity reactions to cisplatin or gemcitabine
- Active or uncontrolled infections such as HIV, hepatitis B or C, or tuberculosis
- Pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Queen Mary Hospital
Hong Kong, Hong Kong, Hong Kong
Actively Recruiting
Research Team
R
Research Assistant
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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