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

NCT ID: NCT01538498

Last Updated: 2013-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2013-02-28

Brief Summary

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* 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

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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

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sang-Yoon Park

Chief, Center for Uterine Cancer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NCCCTS-08-309

Identifier Type: -

Identifier Source: org_study_id

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