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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sang-Yoon Park, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01538498
First received: February 17, 2012
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose
  • 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

Condition
Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Clinical Trial to Develop a Peritoneal Carcinomatosis Index (PCI) in Ovarian

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Devleopment for the peritoneal carcinomatosis index (PCI) [ Time Frame: 55 months ] [ Designated as safety issue: No ]

Enrollment: 134
Study Start Date: April 2008
Study Completion Date: February 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • primary ovarian cancer
  • non-neoadjuvant
  • Debulking operation
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538498

Locations
Korea, Republic of
National Cancer Center
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: Sang-Yoon Park, Chief, Center for Uterine Cancer, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01538498     History of Changes
Other Study ID Numbers: NCCCTS-08-309
Study First Received: February 17, 2012
Last Updated: March 26, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by National Cancer Center, Korea:
PCI
Ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Carcinoma
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 23, 2013