Endometrial waves in women with suspected gynaecological malignancy

Recruiting

Conditions: ovarian tumours
Postmenopausal bloodloss
10038594
10074469

Registration Number: NL-OMON51675

Lead Sponsor: Catharina-ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

Group 1:
- Age >18 years
- Postmenopausal: lack of menstrual cycle for >1 year
- Symptoms vaginal bleeding
Group 2:
- Age >18 years
- Diagnosis of ovarian tumour or mass

Exclusion Criteria

- Mental disability
- Significant language barrier
- History of hysterectomy
- Uterine anomalies (congenital or not congenital)
- Uterine pathologies (leiomyomas, adenomyosis, endometriosis)
- Caesarean section in the past,
- Endometrial ablation in the past,
- Presence of IUD

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints:<br /><br>The primary outcomes investigated were the following uterine contraction<br /><br>features on TVUS:<br /><br>Frequency, in contractions per minute<br /><br>Amplitude (unitless)<br /><br>Direction, in median velocity (from Cervix to Fundus or Fundus to Cervix)<br /><br>Coordination, unitless (via mean squared error, or cross correlation)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>- Histopathological diagnosis based on histopathological examination (benign<br /><br>vs. malignant)<br /><br>- TNM classification of gynaecological malignancy if applicable<br /><br>- 1-year survival and treatment outcomes<br /><br>- Hormonal status</p><br>