HE4 is a Beneficial Biomarker in Endometrial Cancer

Brief Title

HE4 is a Beneficial Biomarker in Endometrial Cancer

Official Title

HE4 is a Beneficial Biomarker in Endometrial Cancer

Brief Summary

      Evaluation of Serum level of Human Epididymis Secretory Protein 4 (HE4) in Endometrial Cancer
      and clinical significant it

Detailed Description

      .Endometrial cancer represents the most common gynecologic cancer, and it is expected to
      become an even greater public health concer as the prevalence of obesity, one of the most
      common risk factors for endometrial cancer, increases worldwide, Approximately 42,160 cases
      are diagnosed annually, 7,780 deaths occur, and more than 4,000 new cases are diagnosed
      yearly (Renehan et al., 2008).

      National Cancer Institute (NCI) statistics shows that while there was an. insignificant
      decline in the incidence of endometrial cancer (EC) from 1997 to 2006 (-0.4 annual percentage
      change), the mortality rate increased significantly in the same time period (+0,3 annual
      percentage change). These data seem to suggest a trend for an increasing frequency of more
      aggressive forms of EC in the United States, which underscores the need for a better
      understanding of the molecular mechanisms and pathways involved in EC pathogenesis (National
      Cancer Institute, 2013).

      The diagnosis is usually done at an early stage, and approximately 70% of endometrial cancers
      are diagnosed as stage I; this results in better prognosis, with a 5-year overall survival
      rate of 90% to 95% (Jemal et al., 2009).

      Almost 20% of patients with endometrial cancer are in the premenopausal state and 10% are
      asymptomatic. In such a case, it is much harder to make an early diagnosis and usually they
      are probably diagnosed at advanced stages (Li et al., 2009).

      An earlier diagnosis represents an imperative goal to improve survival and prognosis of
      patients of endometrial cancer. Actually, there are no certified screening tools for
      endometrial cancer. Pelvic ultrasound as screening for endometrial cancer reaches 80.5% of
      sensitivity, when endometrial echo is > 5 mm, but it dramatically decreases to 20% in
      asymptomatic women; moreover, specificity is low (61%) (Jacobs et al., 2011).

      HE4, a putative protease inhibition containing two (Whey Acid Protein) WAP domains, is
      significantly increased in the endometrioid subtype of EC (Drapkin et al., 2005).

      Tissue microarray and real-time ploymerais chain reaction PCR studies confirmed a high level
      of HE4 expression in both endometrioid and serous types of EC (Jiang et al., 2013), these
      results are consistent with those from other laboratories showing increased HE4 mRNA and
      protein expression in endometrial cancer tissues (Moore el al., 2008; Bignotti et al., 2011).

      Subsequent investigation demonstrated that HE4 are detectable in various normal tissues with
      varying expression levels, yet their levels are significantly increased in EC compared to
      normal endometrium (Jiang et al., 2013).

Study Type

Observational

Primary Outcome

: Evaluation of Serum Level of(HE4) in Benign Endometrial disease and Endometrial Cancer

Condition

Endometrial Cancer

Intervention

evaluate serum level HE4 in endometrial cancer

Study Arms / Comparison Groups

 2 groups

Description:  control group case group

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Diagnostic Test

Estimated Enrollment

Start Date

December 1, 2017

Completion Date

April 1, 2019

Primary Completion Date

April 1, 2019

Eligibility Criteria

        Inclusion Criteria:

        Age (40 - 70 yr old).

        Exclusion Criteria:

          1. Age more than 70 yr and less than 40 yr.

          2. Abnormal cardiac hematological renal hepatic functions.

          3. Breast cancer or other malignancies.

          4. Concomitant benign and for malignant adnexal pathologies.

          5. Hormonal medication.

          6. Patient taking or having chemo-radiotherapy.

          7. Patients unfit for surgical intervention.

          8. Smoker.

Gender

Female

Ages

40 Years - 70 Years

Contacts

M Elhafeez Assistant Professor Obstetrics and Gy, phD, 001149733132, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations

NCT ID

NCT03459976

Organization ID

HE4 in endometrial cancer

Responsible Party

Principal Investigator

Study Sponsor

Ain Shams University

Study Sponsor

M Elhafeez Assistant Professor Obstetrics and Gy, phD, Study Director, Obstetrics and Gynecology

Verification Date

March 2018