Development for the Peritoneal Carcinomatosis Index (PCI) in Ovarian Cancer

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT01538498
• Lead Sponsor: National Cancer Center, Korea

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

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2012-02-17
• Study First Submitted QC: 2012-02-23
• Study First Posted: 2012-02-24
• Primary Completion: 2012-11
• Study Completion: 2013-02
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-26
• Last Update Posted: 2013-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 134

Inclusion Criteria

1. Preoperative clinical diagnosis of ovarian cancer, tubal cancer, and primary peritoneal carcinoma (all stage)
2. Available preoperative image study (CT and/or MRI and/or PET)
3. Patients who gave a written informed consent
4. Patients must be surgical candidate considering medical and psychological condition

Exclusion Criteria

• Patients who refuse to participate or want to withdraw at anytime.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Devleopment for the peritoneal carcinomatosis index (PCI)	55 months

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of