CClinicalTrials.gg
Status unknownNCT03798132Updated Jan 9, 2019

Peritoneal Carcinomatosis Extent Evaluation: Radiologic, Laparoscopic and Pathologic.

An observational study in Peritoneal Carcinomatosis, sponsored by Shimaa Abdalla Ahmed. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-01-09.

Sponsored by Shimaa Abdalla Ahmed · Observational

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
80
Ages
18 Years to 100 Years
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Peritoneal Carcinomatosis

Keywords

  • Ovarian Neoplasms, Laparoscopy, Cytoreduction Surgical Procedures.
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 80 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

This is the only study on the registry with Shimaa Abdalla Ahmed as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

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

Exclusion Criteria:recurrent ovarian cancer

-

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
80 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testlaparoscopy

    evaluation of peritoneal carcinomatosis by laparoscopy

06

What researchers measure

Primary outcomes

  1. peritoneal carcinomatosis

    Agreement in general and in each category between CT, laparoscopy, surgery and pathology was assessed using kappa agreement.

    Time frame: one year

Secondary outcomes

  1. surgical decision making.

    correlation of peritoneal carcinomatosis categorization with surgical decision

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • South Egypt Cancer Institute
    Assiut, 11517, Egypt
    Recruiting
08

References and documents

Publications

  • Fagotti A, Ferrandina G, Fanfani F, Garganese G, Vizzielli G, Carone V, Salerno MG, Scambia G. Prospective validation of a laparoscopic predictive model for optimal cytoreduction in advanced ovarian carcinoma. Am J Obstet Gynecol. 2008 Dec;199(6):642.e1-6. doi: 10.1016/j.ajog.2008.06.052. Epub 2008 Sep 17. PubMed 18801470 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03798132
Lead sponsor
Shimaa Abdalla Ahmed
Responsible party
Shimaa Abdalla Ahmed (lecturer of radiodiagnosis, South Egypt Cancer Institute) — Sponsor-investigator
First posted
Jan 9, 2019
Start date
Jan 1, 2019
Primary completion
Jun 11, 2019 (estimated)
Completion
Dec 2020 (estimated)
Last update
Jan 9, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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