Prospective evaluation of Human Epididymal protein 4 (HE4) as predictor of malignancy in patients with a ovarian mass.

Completed

• Conditions: Ovarian cancer; 10038594

• Registration Number: NL-OMON47242
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1. Age >=18 years
2. Presence of a complex ovarian mass
3. Understanding of Dutch or English language
4. Risk of malignancy score determined in referral hospital
5. General criteria:
a. Fit for laparotomy or laparoscopy to obtain a histologic diagnosis
b. Written informed consent
c. Normal Glomerular Filtration Rate (GFR): >60 ml/min/1,73 m2

Exclusion Criteria

1. Age <18 years
2. Benign aspect of cyst including simple unilocular cyst for which RMI score is not calculated
3. Multiple malignancies at the same time
4. WHO performance status >= 3
5. Cancer already confirm in biopsy or ascites
6. Suspicion of extra-abdominal metastases

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The sensitivity and specificity with the addition of serum HE4 measurement, as<br /><br>2nd step after calculation of the RMI score, for triage of patients with an<br /><br>ovarian mass.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Calculation of cost-effectiveness of addition of serum HE4 measurement.<br /><br>Evaluation of impact of referral to an oncology center. Residual blood will be<br /><br>storred for future research. Possible implication will be the predictive value<br /><br>of cell-free tumor DNA (ctDNA).</p><br>