ISRCTN45238573
Completed
未知
HE4/ROMA (Risk of Ovarian Malignancy Algorithm) Evaluation Study in Malaysian Women
Abbott Laboratories (Singapore)0 sites600 target enrollmentApril 4, 2014
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Ovarian cancer
- Sponsor
- Abbott Laboratories (Singapore)
- Enrollment
- 600
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Malaysian females consenting to undergo surgery based on the finding of adnexal mass.
- •2\. Adnexal mass must be verified by imaging.
- •3\. Presence of at least one of the ACOG/SCO guideline criteria.
- •4\. Able to understand and sign the Informed Consent forms. For females \<18 years old, consent will be obtained from their parents or guardian.
Exclusion Criteria
- •1\. Previous history of ovarian or primary peritoneal cancer
- •2\. Subject previously confirmed with endometriosis
- •3\. Any women with any known active malignancy
- •4\. Subjects with previous bilateral oophorectomy
- •5\. Subjects known to be pregnant
- •6\. Subjects with end\-stage renal failure
- •7\. Subjects who previously underwent an organ transplantation
Outcomes
Primary Outcomes
Not specified
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