Clinical trial NCT03459976: HE4 is a Beneficial Biomarker in Endometrial Cancer
Official title: HE4 is a Beneficial Biomarker in Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Cancer
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 87
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Control group: 40 Patients with abnormal vaginal bleeding and diagnosed benign endometrial pathology by endometrial biopsy.

Case group: 45 Patients with abnormal vaginal bleeding and diagnosed endometrial cancer at prior endometrial biopsy.

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).

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.

Primary outcomes:
measure: : Evaluation of Serum Level of(HE4) in Benign Endometrial disease and Endometrial Cancer
timeFrame: 1 yeare
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbasyia
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbasyia
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Obstetrics and Gynecology
name: M Elhafeez Assistant Professor Obstetrics and Gy, phD
role: STUDY_DIRECTOR
affiliation: ASU
name: H Fathy Assistant Professor Obstetrics and Gy, phD
role: STUDY_DIRECTOR
References:
citation: Benati M, Montagnana M, Danese E, Paviati E, Giudici S, Ruzzenente O, Franchi M, Lippi G. The clinical significance of DJ-1 and HE4 in patients with endometrial cancer. J Clin Lab Anal. 2018 Jan;32(1):e22223. doi: 10.1002/jcla.22223. Epub 2017 Apr 4.