The primary objective of this study is to evaluate the additional value of biomarker HE4, as second step after the RMI score, in the triage of patients with an ovarian mass. We aim to improve the referral process to oncological centers. Secondary…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Correct characterization of an ovarian mass is important for the referral of
patients with a high risk of malignancy, to a specialized oncologic center.
Currently, the Risk of Malignancy Index (RMI), with a cut-off value of 200, is
used in the Netherlands to select patients with a high risk of ovarian cancer.
However, the sensitivity and specificity of the RMI score are not optimal.
Currently, 40% of the referred patients have benign disease in the final
pathology. This incorrect characterisation of the ovarian mass causes an
increase in health care costs and may lead to anxiety in the patient because of
the referral to an oncologic centre. Serum biomarker Human Epididymal protein 4
(HE4) is increased in patients with epithelial ovarian cancer and to a lesser
extent in patients with a benign ovarian mass. Multiple retrospective studies
have shown that mainly the specificity to distinguish a benign ovarian mass
from ovarian cancer is improved when HE4 is used compared with CA125.
Study objective
The primary objective of this study is to evaluate the additional value of
biomarker HE4, as second step after the RMI score, in the triage of patients
with an ovarian mass. We aim to improve the referral process to oncological
centers. Secondary outcomes are cost-effectiveness and impact of referral to an
oncology center.
Study design
Prospective observational cohort study.
Study burden and risks
No risk or benefit for the specific patient. THe group of patients might
benefit it a better triage of patients with an ovarian mass will be possible.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58253.031.16 |