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
87
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