Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-28 @ 6:46 AM
Study NCT ID:
NCT07022535
Status:
RECRUITING
Last Update Posted:
2025-07-02
First Post:
2025-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalised Timing of Interval Debulking Surgery in Advanced Ovarian Cancer
Sponsor:
The University of Hong Kong
Organization:
Study Overview
Official Title:
Personalised Timing of Interval Debulking Surgery Based on KELIM After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer - a Pilot Study
Status:
RECRUITING
Status Verified Date:
2025-06
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:
PRESELECT-0
Brief Summary:
About 70% of epithelial ovarian cancer patients are diagnosed at advanced stage. When primary optimal surgery is not possible, neoadjuvant chemotherapy will followed by interval debulking surgery is one treatment option. However, there is no consensus on the optimal timing of the surgery. CA125 is a well-known tumor marker in ovarian cancer. Its kinetic change has been proven to correlate with the patients' response to chemotherapy and chance of optimal resection. This study aims to utilize the kinetic change of CA125 to customize the timing of surgery for individual patients.
Detailed Description:
Recruited patients will have additional CA125 at 4th (before administration of chemotherapy), and 5th week after the first cycle of chemotherapy. CA-125 ELIMination Rate Constant K (KELIM) will be determined. Patients with KELIM =\>1 will receive radiological assessment and undergo internal debulking surgery if the disease is operable. Patients with KELIM \<1 will have alternative management, such as addition of bevacizumab or changing to dose-dense chemotherapy, and defer the interval debulking surgery
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HKUCTR-3091 | REGISTRY | HKU Clinical Trials Registry | View |