NCT02856841

Brief Summary

44 patients were enrolled in this study as they had malignant epithelial ovarian tumor.Pre-operative staging was assessed by CT scan based on FIGO classification and compared to the standard laparotomy surgical staging. Maximal surgical effort for Optimum cytoreduction was achieved and the risk factors for sub-optimal cytoreduction were studied

Trial Health

100
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

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

January 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
Last Updated

August 5, 2016

Status Verified

August 1, 2016

Enrollment Period

1.4 years

First QC Date

August 1, 2016

Last Update Submit

August 2, 2016

Conditions

Ovarian Cancer

Keywords

epithelial ovarian canceroptimum cytoreduction

Outcome Measures

Primary Outcomes (1)

  • feasibility of optimum cytoreduction

    ability to remove all gross lesions from the tumor intraoperatively and leaving no ovarian lesion seen by naked eye of the expert surgeon

    1 year after surgery

Study Arms (2)

optimum cytoreduction

without any gross tumor residue after surgery

Suboptimum cytoreduction

with any gross tumor residue after surgery

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

44 patients were enrolled in this study as they had malignant epithelial ovarian tumor (EOC), FIGO stage II, III, and IV.

You may qualify if:

  • malignant epithelial ovarian tumor (EOC)
  • FIGO stage II, III, and IV.

You may not qualify if:

  • Patients with previous abdominal or pelvic major surgery, synchronous abdominal or pelvic pathology or medically unfit for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

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 DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Ahmed Maged, MD

    Kasr Alainy medical school

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 5, 2016

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 5, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share