Evaluation of a chemiluminescent immunoassay for serum HE4

Evaluation of a chemiluminescent immunoassay for serum HE4 - Evaluation of serum HE4 assay

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000006747

Enrollment

470

Registered

2011-12-09

Start date

2011-12-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Ovarian cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Ovarian tumor - Female 20years oled or above, less than 80 years old. - Ovarian mass suspected by ultrasound, MRI, or CT. Undergoing laparotomy/surgery. - The first treatment is a laparotomy/surgery. - Pathology results available within the study period. 2. Healthy subjects - Female 20years oled or above, less than 80 years old.

Exclusion criteria

Exclusion criteria: 1. Ovarian tumor - The dirst treatment is chemotherapy and/or radiotherapy, not laparotomy/surgery. - Pathology results on the primary tumor not available. 2. Healthy subjects - History of bilateral oophorectomy. - Abnormality found in ovary by MRI or PET. - Aware of gynecological diseases. - Aware of internal diseases. - Aware of pregnancy.

Design outcomes

Primary

Measure	Time frame
Sensitivity, Specificity	—

Countries

Japan

Outcome results