Clinical trial · Observational
Elecsys HE4 Chinese Reference Value Study
A Multi-center Reference Value Study of Elecsys HE4 in Chinese Population
- 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)
Aim of this study is to provide specimens for establishing reference values of HE4 in an apparently healthy Chinese population using the Roche Elecsys HE4 assay tested on variety of Elecsys and cobas brand immunoassay analyzers. This reference range will be compared to population of subjects who have signs and symptoms of various benign and malignant diseases, including ovarian cancer. This reference range will also be compared to the levels of HE4 in individual subjects who have been diagnosed with ovarian cancer and are being followed longitudinally for recurrence or progression of their disease.
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 Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Apparently healthy subjects
- label
- Non-malignant conditions subjects
- label
- Malignant conditions subjects
Primary outcomes (1)
- measure
- Establish reference in Chinese population
- timeFrame
- October 2012 - March 2013
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (all cohorts): * appropriate clinical data * normal appearance of sample * minimum 0.5 ml volume available Exclusion Criteria (all cohorts): * \< 18 years of age * insufficient volume * insufficient clinical information * \> 3 freeze/thaw cycles of samples * Stored or shipped at \> 0°C * Icteric, lipemic, hemolytic, substantial particulates
References
Publications (0)
Data not yet available