Peritoneal Carcinomatosis Extent Evaluation: Radiologic, Laparoscopic and Pathologic.

January 7, 2019 updated by: Shimaa Abdalla Ahmed

Imaging Evaluation of Peritoneal Carcinomatosis Extent

pathologically proved ovarian cancer patients that underwent contrast enhanced abdomino-pelvic CT and diagnostic laparoscopy before cytoreductive surgery (CRS) will be included in the study. Calculation of PCI (peritoneal cancer index) using Sugarbaker's method, peritoneal carcinomatosis extent will be categorized into low, moderate and large. Agreement in general and in each category between CT, laparoscopy, surgery and pathology will be assessed using kappa agreement.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

we will search medical records of primary ovarian cancer patients underwent CT abdomen, laparoscopy followed by cytoreductive surgery to calculate peritoneal carcinomatosis extent by each modality.

Regional PCI was calculated in each of the 13 anatomical abdominopelvic regions, then total PCI by summation of the lesion size score, it ranged from 0 to 39. Categorization of peritoneal carcinomatosis was classified into 3 categories low if PCI < 10, moderate if 10-20, and large if >20.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 11517
        • Recruiting
        • South Egypt Cancer Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

pathologically proved ovarian cancer patients recived cytoreductive surgery and underwent preoperative CT and diagnostic laparoscopy

Description

Inclusion Criteria:pathologically proved ovarian cancer patients underwent contrast enhanced abdominopelvic CT and diagnostic laparoscopy before cytoreductive surgery -

Exclusion Criteria:recurrent ovarian cancer

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
peritoneal carcinomatosis
Time Frame: one year
Agreement in general and in each category between CT, laparoscopy, surgery and pathology was assessed using kappa agreement.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgical decision making.
Time Frame: one year
correlation of peritoneal carcinomatosis categorization with surgical decision
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shimaa Abdalla Ahmed

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ANTICIPATED)

June 11, 2019

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 7, 2019

First Posted (ACTUAL)

January 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 9, 2019

Last Update Submitted That Met QC Criteria

January 7, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SouthECI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peritoneal Carcinomatosis

Clinical Trials on laparoscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe