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NCT01538498 Clinical Trial

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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01538498
Other study ID # NCCCTS-08-309
Secondary ID
Status Completed
Phase N/A
First received February 17, 2012
Last updated March 26, 2013
Start date April 2008
Est. completion date February 2013

Study information
Verified date March 2013
Source National Cancer Center, Korea
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 134
Est. completion date February 2013
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of National Cancer Center Goyang-si Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Devleopment for the peritoneal carcinomatosis index (PCI) 55 months No
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