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Clinical Trials/ISRCTN45238573
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.

Registry
who.int
Start Date
April 4, 2014
End Date
TBD
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Abbott Laboratories (Singapore)

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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