MedTrace Logo

HE4 in the Diagnostic Approach of Endometrial Cancer in Patients With Postmenopausal Bleeding

NCT04867109 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-09-17

No results posted yet for this study

Summary

This study aims to explore the sensitivity of an innovative marker, HE4, in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings.

Conditions

  • Endometrial Neoplasms
  • Postmenopause
  • Uterine Hemorrhage
  • Cancer Biomarker
  • CA 125 Antigen

Interventions

OTHER

Patients with Post menopausal bleeding

Any patient presenting post-menopausal bleeding who is to undergo hysteroscopy or hysterectomy will have an additional blood tube taken during her pre-operative blood work-up for the determination of the serum markers HE4 and CA125, after having obtained her non-opposition to participate in the study. The blood tube collected for the research will be sent to the biochemistry laboratory of the Nantes University Hospital for a centralized analysis. This analysis will be done sequentially and the results will not be transmitted to the investigator. At D0, the day of surgery, the operative report will be retrieved as well as the quality of life questionnaires SF12 and PGI-I and the acceptability questionnaire completed before surgery. At 1 month after surgery, the anatomopathological results will be retrieved as well as the value of the tumour markers CA125 and HE4.

DIAGNOSTIC_TEST

CA125 and HE4 assays

Blood was collected in a standard heparinized vial. Samples were sent to a central laboratory unit (biochemistry laboratory at the Nantes university hospital), centrifuged and plasmas were stored at -20°C until analysis. Plasma CA125 and HE4 concentrations were determined by run in single measurements using an electrochemiluminescence Elecsys immunoassay (ECLIA) on a Roche Diagnostics Cobas 8000® e602 analyser (Roche Diagnostics, Mannheim, Germany).

Sponsors & Collaborators

  • Roche Diagnostics GmbH

    collaborator INDUSTRY

  • Nantes University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-25
Primary Completion
2022-08-01
Completion
2022-09-01

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04867109 on ClinicalTrials.gov