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Identification and Characterization of Endometrial Cancer With Specific Tumor Markers in Serum and Endometrial Tissue

NCT03498924 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2020-02-11

No results posted yet for this study

Summary

Endometrial cancer is the most common malignant tumor of the female genital tract in our means. The diagnosis is made by endometrial biopsy sampling with anatomopathological analysis which pinpoints the cell line and the level of cell differentiation. Its treatment is surgical with adjuvant treatment (chemotherapy or radiotherapy) besides, depending on the staging. Thus far, in the first diagnosis it is only request the tumor marker CA125 in serum, but there are studies that identify the HE4 protein in blood as a feasible marker for endometrial cancer. Furthermore, the staging changes the surgical and the adjuvant treatment: in its early stages, surgery is based on hysterectomy and double adnexectomy, however, in later stages it is necessary to add pelvic and paraaortic lymphadenectomy with the associated comorbidity. This makes extremely important that the preoperative diagnosis is accurate. The aim of this study is to identify and characterize the HE4, Ki67, p53 and other potential biomarkers in endometrial tissue in order to diagnose patients with disease only with a biopsy. Moreover, the investigators are searching for connections among these markers and prognostic factors such as grade of cell differentiation, cell line, lymphatic affectation, tumor stage or even features as survival or disease free survival.

Conditions

  • Endometrial Neoplasm Malignant

Interventions

DIAGNOSTIC_TEST

Measure of biomarkers in serum and endometrial tissue

Blood sample and endometrial sample

Sponsors & Collaborators

  • Fundación Investigación Sanitaria en León

    lead OTHER

Principal Investigators

  • Tatiana Cuesta-Guardiola, Medicine · Hospital de Leon

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2018-08-01
Completion
2019-06-01

Countries

  • Spain

Study Locations

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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 NCT03498924 on ClinicalTrials.gov