Status:

TERMINATED

Study Into a New Diagnostic Tool (Simple Ultrasound-based Rules) in Patients With Adnexal Masses

Lead Sponsor:

Maastricht University Medical Center

Collaborating Sponsors:

Laurentius Hospital Roermond

St.Jans Gasthuis Weert

Conditions:

Ovarian Carcinoma

Ovarian Cancer

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

This study is performed to compare the diagnostic performance and cost-effectiveness of different diagnostic methods for differentiating benign from malignant adnexal (ovary or Fallopian tube) masses:...

Detailed Description

Estimating whether an adnexal mass is malignant or not is essential in the preoperative management of adnexal masses. Recognizing cancer means treatment is not delayed and appropriate staging or debul...

Eligibility Criteria

Inclusion

  • Female patient;
  • Diagnosed in one of the participating centers with at least one pelvic mass that is suspected to be of ovarian origin;
  • Are to undergo surgery in order to obtain a final histological diagnosis;
  • 18 years of age or older.

Exclusion

  • Pregnant patients;
  • Patients aged under 18 years;
  • Patients in whom the surgery does not take place, or takes place more than 120 days after RMI and simple ultrasound-based rules are performed;
  • Patients with a prior bilateral oophorectomy;
  • Patients with insufficient or missing data;
  • Patients who do not give or are incapable of giving an informed consent;
  • Patients who are not able or willing to travel to the center hospital for additional diagnostic procedures.

Key Trial Info

Start Date :

September 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2015

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT02218502

Start Date

September 1 2014

End Date

October 1 2015

Last Update

March 28 2017

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Maastricht University Medical Centre (MUMC+)

Maastricht, Netherlands

2

Laurentius Ziekenhuis Roermond

Roermond, Netherlands

3

Orbis Medical Sittard

Sittard, Netherlands, 6162 BG

4

VieCuri Venlo

Venlo, Netherlands