Sentinel Lymph Node in Early Ovarian Cancer (SENTOV)

October 17, 2019 updated by: Instituto de Investigacion Sanitaria La Fe
This research study evaluates the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with early stage ovarian cancer.

With this research study it will be evaluated the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

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

  • Spain
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico La Fe

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Informed consent signed previously to performing any procedure related to the clinical trial.
  • Patients who are women 18 years of age or older at the moment of the randomization.
  • Patients with anatomopathological diagnosis of malignant ovarian tumor in a deferred study proposals for staging surgery or patients with suspicious tumor of malignancy who are going to be subjected to exploratory lapaotomy or laparoscopy and operative biopsy, and in the case this is positive, surgery of staging will be performed .

Exclusion Criteria:

  • Informed consent not obtained or withdraw.
  • Benign result in extemporaneous study
  • Previous history of vascular surgery in the aorta, cava or pelvic vessels
  • Previous pelvic or para-aortic lymphadenectomy
  • Previous lymphoma
  • Previous abdomino-pelvic tumor
  • Previous allergic reaction to indocyanine green
  • Pregnancy / lactation
  • Severe adherent syndrome

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with ovarian cancer
Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection
Other: sentinel node technique
Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of performing the sentinel node technique (Detection rate)
Time Frame: Intraoperative (day 0)
The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with previous ovarian surgery injecting the tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.
Intraoperative (day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of realization of the technique
Time Frame: Intraoperative (day 0)
Intraoperative (day 0)
Rate of realization of the technique
Time Frame: After anatomopathological study (day 30)
After anatomopathological study (day 30)
Anatomical location of the sentinel node(s)
Time Frame: Intraoperative (day 0)
Assessed by radiation (99Tc-nanocoloides) and staining with indocyanine green
Intraoperative (day 0)
Anatomical location of the sentinel node(s)
Time Frame: After anatomopathological study (day 30)
Assessed by the pathologist
After anatomopathological study (day 30)
Number of detected sentinel nodes
Time Frame: Intraoperative (day 1)
Intraoperative (day 1)
Number of detected sentinel nodes
Time Frame: After anatomopathological study (day 30)
After anatomopathological study (day 30)
Characterization of the sample by collecting baseline characteristics
Time Frame: Screening (day 0)
Age (years)
Screening (day 0)
Characterization of the sample by collecting baseline characteristics
Time Frame: Screening (day 0)
Weight (kilograms)
Screening (day 0)
Characterization of the sample by collecting baseline characteristics
Time Frame: Screening (day 0)
Height (centimeters)
Screening (day 0)
Characterization of the sample by collecting baseline characteristics
Time Frame: Screening (day 0)
BMI (kg/m^2)
Screening (day 0)
Characterization of the sample by collecting baseline characteristics
Time Frame: Screening (day 0)
Previous gynecological surgery and previous pathological anatomy
Screening (day 0)
Characterization of the sample by collecting tumor markers
Time Frame: Day 0
Ca 125 and Ca 19.9.
Day 0
Characterization of the sample by collecting intraoperative findings
Time Frame: Day 0
Ascites (milliliters)
Day 0
Characterization of the sample by collecting intraoperative findings
Time Frame: Day 0
Tumor size (centimeters) of: right ovary, left ovary, right tube, left tube, uterus, pelvic nodes, para-aortic nodes, and tumor in upper hemiabdomen.
Day 0
Characterization of the sample by collecting surgical procedures
Time Frame: Day 0
Hysterectomy, adnexectomy, appendectomy, peritonectomy / peritoneal biopsy, omentectomy, lymphadenectomy and blood transfusion (Realized or Unrealized)
Day 0
Characterization of the sample by collecting surgical procedures
Time Frame: Day 0
Intraoperative complications
Day 0
Characterization of the sample by collecting surgical procedures
Time Frame: Day 0
Result of intraoperative biopsy (unrealized, malignant, benign)
Day 0
Characterization of the sample by collecting surgical procedures
Time Frame: Day 0
Estimated blood loss (milliliters)
Day 0
Characterization of the sample by collecting surgical procedures
Time Frame: Day 0
Surgical time (minutes)
Day 0

Collaborators and Investigators

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

Sponsor

Instituto de Investigacion Sanitaria La Fe

Investigators

  • Principal Investigator: Victor Lago, Instituto de Investigación Sanitaria La Fe

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)

March 23, 2018

Primary Completion (Actual)

August 21, 2019

Study Completion (Actual)

August 21, 2019

Study Registration Dates

First Submitted

February 12, 2018

First Submitted That Met QC Criteria

February 26, 2018

First Posted (Actual)

March 2, 2018

Study Record Updates

Last Update Posted (Actual)

October 18, 2019

Last Update Submitted That Met QC Criteria

October 17, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SENTOV

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

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 Ovarian Cancer

Clinical Trials on sentinel node technique

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe