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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47242

Enrollment

300

Registered

2018-10-11

Start date

2017-04-12

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer

Interventions

Ovarian cancer

Prediction

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria: 1. Age = 3 5. Cancer already confirm in biopsy or ascites 6. Suspicion of extra-abdominal metastases

Design outcomes

Primary

Measure	Time frame
The sensitivity and specificity with the addition of serum HE4 measurement, as 2nd step after calculation of the RMI score, for triage of patients with an ovarian mass.	—

Secondary

Measure	Time frame
Calculation of cost-effectiveness of addition of serum HE4 measurement. Evaluation of impact of referral to an oncology center. Residual blood will be storred for future research. Possible implication will be the predictive value of cell-free tumor DNA (ctDNA).	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)