Clinical trial · Interventional
HE4 as a Relapse Biomarker in Ovarian Cancers
Determination of the Interest of HE4 as a Relapse Biomarker in Ovarian Cancers Stages IIIb, IIIc and IV After Neo-adjuvant Chemotherapy and Surgery.
- 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)
HE4 is a more sensitive marker than CA-125 in patients with ovarian cancers. The interest of serum HE4 before surgery has been demonstrated to predict overall survival and its interest has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk patients. To date, no study shows clearly the predictive potential of serum HE4 as an early relapse biomarker in ovarian cancers.
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 Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Experimental arm | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study arm
- interventionNames
- Other: Experimental arm
Primary outcomes (1)
- measure
- To evaluate the predictive and prognostic value of HE4 marker
- timeFrame
- 24 months
- description
- Serum concentration of HE4 (pMol) will be analysed at each visit
Secondary outcomes (3)
- measure
- Compare the evolution of HE4 and CA-125 serum concentration
- timeFrame
- 24 months
- description
- Serum concentration of HE4 and CA-125 (pMol) will be analysed and compared at the time of diagnosis, at each neoadjuvant chemotherapy cycle, before the surgery, and at each chemotherapy cycle
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ovarian adenocarcinoma stage IIIa, IIIb or IV pleural, cytologically or histologically proven * Patient scheduled to undergo neoadjuvant chemotherapy based on platinum followed by surgery and adjuvant chemotherapy * Age ≥ 18 years . * Performance status ECOG \> or = 2 * Adequate haemoglobin rate ≥ 10 g/dL * Ability to provide written informed consent * Patient's legal capacity to consent to study participation Exclusion Criteria: * Any previous treatment with platinum for ovarian carcinoma * Patient with visceral metastases * Contraindication for blood test * Contraindication for surgery * Contraindication for bevacizumab treatment
References
Publications (0)
Data not yet available