NCT03235648

Brief Summary

Evaluation of surgical excision of cardiophrenic lymph nodes in patients with advanced ovarian cancer

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable ovarian-cancer

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable ovarian-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

July 2, 2017

Last Update Submit

July 30, 2017

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • number of CPN retrieved/pathological nodes

    correlation of radiological active lymph nodes with pathological findings

    up to 3 years

Secondary Outcomes (1)

  • Progression free survival

    up to 2 years following the end of study

Other Outcomes (1)

  • Overall survival

    up to 2 years following the end of study

Study Arms (1)

cardiophrenic nodes excision in ovarian cancer

EXPERIMENTAL

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

Interventions

cardiophrenic lymph nodes resectionPROCEDURE

surgical resection

cardiophrenic nodes excision in ovarian cancer

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 )

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology center, Mansoura University

Cairo, Dakhlia, 35116, Egypt

RECRUITING

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

Central Study Contacts

Basel R. Abdelfattah, MD, MRCS

CONTACT

01001974340dr.basel@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 2, 2017

First Posted

August 1, 2017

Study Start

June 1, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2023

Last Updated

August 1, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)