Clinical trial · Observational
The Role of HE4 in the Follow-up of Advanced Ovarian, Fallopian Tube and Primary Peritoneal Cancer
The Role of HE4 in the Follow-up of Advanced Ovarian, Fallopian Tube and Primary Peritoneal Cancer: First Prospective Multicentre Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate and to compare the effectiveness of CA-125 and HE4 serum levels in epithelial ovarian cancer (OC) in follow-up in terms of time to detection of elevation after the end of the first line treatment. To evaluate the lead-time of the rise of marker levels before epithelial OC recurrence diagnosis by Computed tomography (CT) imaging method. To evaluate the appropriate HE4 cut-off value for follow-up of patients after the treatment of ovarian, Fallopian tube and primary peritoneal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Determination of CA 125 and HE4, Computed tomography | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Advanced ovarian cancer patients
- description
- Patient with histologically confirmed advanced (FIGO III and IV) epithelial ovarian, fallopian tube or primary peritoneal carcinoma with complete remission after first line treatment are included into the study. The patient is regularly followed up every 3-4 months, blood sample collection is performed to determinate tumor marker found in blood, elevated by the presence of cancer recurrence. In case of one or both of tumor markers are elevated, computed tomography examination with intravenous contrast agent of chest and abdomen is performed to detect the recurrence of the disease.
- interventionNames
- Other: Determination of CA 125 and HE4, Computed tomography
Primary outcomes (2)
- measure
- Serum levels of tumor marker CA-125
- timeFrame
- two years after study enrollment
- description
- kU/l
- measure
- Serum levels of tumor marker HE4
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * advanced ovarian cancer, stage FIGO III and IV * histology types: high-grade serous, low-grade serous, endometrioid, clear cell, undifferentiated * completed ovarian cancer surgery and platinum-based chemotherapy Exclusion Criteria: * positivity of tumor markers CA 125 and HE4 during study enrollment * signs of cancer at computed tomography scan during study enrollment
References
Publications (0)
Data not yet available