NCT01538498

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 28, 2013

Status Verified

March 1, 2013

Enrollment Period

4.6 years

First QC Date

February 17, 2012

Last Update Submit

March 26, 2013

Conditions

Ovarian Cancer

Keywords

PCIOvarian cancer

Outcome Measures

Primary Outcomes (1)

  • Devleopment for the peritoneal carcinomatosis index (PCI)

    55 months

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* primary ovarian cancer * non-neoadjuvant * Debulking operation

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Center for Uterine Cancer

Study Record Dates

First Submitted

February 17, 2012

First Posted

February 24, 2012

Study Start

April 1, 2008

Primary Completion

November 1, 2012

Study Completion

February 1, 2013

Last Updated

March 28, 2013

Record last verified: 2013-03

Locations

KR(1)