A Clinical Trial to Develop a Peritoneal Carcinomatosis Index (PCI) in Ovarian
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ovarian Cancer
- Sponsor
- National Cancer Center, Korea
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Devleopment for the peritoneal carcinomatosis index (PCI)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
- Primary objectives: To develop peritoneal carcinomatosis index (PCI) for ovarian cancer, tubal cancer and primary peritoneal cancer that can represent perioperative intraperitoneal tumor burden objectively
- Secondary objectives: To establish the relationship and find out clinical significance between PCI, tumor location and tumor characteristics
Detailed Description
Patients with primary ovarian cancer * Informed consent * Digital photography \& Checking PCI (tumor size, number, and Characteristics) * Postoperative surveillance(tumor marker, image and physical examination) 1. Developing the best fitting PCI model to reflect recurrence-free survival and overall survival * Selection of items * Weighting by items and tumor characteristics 2. Analysis of prognostic impact of PCI compared to conventional staging system (FIGO stage) for ovarian cancer
Investigators
Sang-Yoon Park
Chief, Center for Uterine Cancer
National Cancer Center, Korea
Eligibility Criteria
Inclusion Criteria
- •Preoperative clinical diagnosis of ovarian cancer, tubal cancer, and primary peritoneal carcinoma (all stage)
- •Available preoperative image study (CT and/or MRI and/or PET)
- •Patients who gave a written informed consent
- •Patients must be surgical candidate considering medical and psychological condition
Exclusion Criteria
- •Patients who refuse to participate or want to withdraw at anytime.
Outcomes
Primary Outcomes
Devleopment for the peritoneal carcinomatosis index (PCI)
Time Frame: 55 months