Evaluation of Surgical Excision of Cardiophrenic Lymph Nodes in Patients With Advanced Ovarian Cancer

July 30, 2017 updated by: Basel Refky, MD, Mansoura University
Evaluation of surgical excision of cardiophrenic lymph nodes in patients with advanced ovarian cancer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The role of cardiophrenic lymph node assessment and excision in advanced ovarian cancer is still debatable , correlation of radiological finding with pathological findings after reaction of radiological positive lymph nodes and its impact in diseases free survival and over all survival

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
    • Dakhlia
      • Cairo, Dakhlia, Egypt, 35116
        • Recruiting
        • Oncology center, Mansoura University
        • 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

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria

  • Ovarian cancer patient (FIGO stage III-IV)
  • Preoperative CT showing CPLN with short axis diameter > 5mm.
  • Anathestically fit patient (ASA score I or II).
  • Accepted pulmonary function test.
  • Patient who received neoadjuvant chemotherapy or recurrent cases may be enrolled
  • Written informed consent.
  • Achievement of optimal cytoreduction intra-abdominal( No residual disease more than 1 cm )

Exclusion Criteria:

  • Anathestically unfit patient
  • Unresectable disease
  • Patient refusal
  • No detected CPLN by preoperative radiology

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: cardiophrenic nodes excision in ovarian cancer
We are going to evaluate the comorbidites and impact of cardiophrenic lymph nodes excision in cases of advanced ovarian cancer with positive cardiophrenic lymph nodes
Procedure: cardiophrenic lymph nodes resection
surgical resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of CPN retrieved/pathological nodes
Time Frame: up to 3 years
correlation of radiological active lymph nodes with pathological findings
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: up to 2 years following the end of study
2 years progression without disease recurrence
up to 2 years following the end of study

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: up to 2 years following the end of study
2 years survivals of the patients
up to 2 years following the end of study

Collaborators and Investigators

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

Sponsor

Mansoura University

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)

June 1, 2017

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

July 2, 2017

First Submitted That Met QC Criteria

July 30, 2017

First Posted (ACTUAL)

August 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 30, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R/17.05.162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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