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Clinical Trials/NCT01538498
NCT01538498
Completed
Not Applicable

A Clinical Trial to Develop a Peritoneal Carcinomatosis Index (PCI) in Ovarian

National Cancer Center, Korea1 site in 1 country134 target enrollmentApril 2008
ConditionsOvarian Cancer

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

Registry
clinicaltrials.gov
Start Date
April 2008
End Date
February 2013
Last Updated
13 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

Study Sites (1)

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