Health TrialsbyHealthPanel

Korean Prospective Upper Tract Urothelial Carcinoma Cohort

ConditionUrothelial Carcinoma (UC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSamsung Medical Center

About this trial

This is a single-center, prospective, non-interventional observational cohort study designed to establish a structured recurrence monitoring platform in Korean patients with high-grade non-metastatic upper tract urothelial carcinoma (UTUC).

Eligible adult patients scheduled to receive neoadjuvant chemotherapy followed by radical nephroureterectomy will undergo circulating tumor DNA (ctDNA) sampling prior to chemotherapy initiation and once between 1-6 months after surgery.

Clinical, imaging, pathological, and longitudinal follow-up data will be prospectively collected to enable long-term monitoring of recurrence and survival outcomes.

The primary objective is to establish a prospective cohort integrating clinical and molecular data to support future translational research and recurrence prediction modeling in UTUC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 19 years

Disqualifiers

Evidence of distant metastasis (M1)

Trial population

Adult Korean patients with high-grade non-metastatic upper tract urothelial carcinoma (cT2-T4, cN0-1, M0) who are candidates for neoadjuvant chemotherapy followed by radical nephroureterectomy at a single tertiary referral center.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Peripheral blood collection for ctDNA analysis

    Other intervention

    Peripheral blood samples (20-30 mL) will be collected prior to neoadjuvant chemotherapy initiation and once between 1-6 months after surgery for circulating tumor DNA (ctDNA) analysis. No investigational drug or device is administered. All oncologic treatments are conducted according to standard clinical practice.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: High-grade non-metastatic UTUC prospective cohort1 intervention

Trial outcomes

Primary outcomes

1

Recurrence-free survival (RFS)

Recurrence is defined as radiographic and/or pathologic evidence of local recurrence, regional nodal recurrence, distant metastasis, or intravesical recurrence documented during routine follow-up.

Time frame
From date of radical nephroureterectomy to first documented recurrence or last follow-up (up to 5 years)

Secondary outcomes

1

Overall survival (OS)

Time frame
From date of surgery to death from any cause or last follow-up (up to 5 years)
2

Cancer-specific survival (CSS)

Time frame
From date of surgery to death due to UTUC or last follow-up (up to 5 years)
3

ctDNA positivity rate at each time point

Time frame
Baseline (pre-NAC) and postoperative 1-6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samsung Medical Center

Lead sponsor

Source ClinicalTrials.gov
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