Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257017
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-02-05
Brief Title:
Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma A Pilot Randomized Controlled Trial
Sponsor:
Yung NA
Organization:
The University of Hong Kong
Study Overview
Official Title:
Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma A Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None