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HE4 is a Beneficial Biomarker in Endometrial Cancer

HE4 is a Beneficial Biomarker in Endometrial Cancer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03459976
Acronym
HE4
Enrollment
87
Registered
2018-03-09
Start date
2017-12-01
Completion date
2019-04-01
Last updated
2019-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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).

Interventions

DIAGNOSTIC_TESTevaluate serum level HE4 in endometrial cancer

1. HE4 in beignin endometrial diseases 2. HE4 in endometrial cancer

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 70 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
: Evaluation of Serum Level of(HE4) in Benign Endometrial disease and Endometrial Cancer1 yeare* Evaluation of Serum Human Epididymis Secretory Protein 4 (HE4) in Benign Endometrial Endometrial Cancer Disease and * Evaluation of Serum Human Epididymis Secretory Protein 4 (HE4) in Benign Endometrial Endometrial Cancer Disease and c: Evaluation of Serum Human Epididymis Secretory Protein 4 (HE4) in Benign Endometrial Endometrial Cancer Disease and cas cotrol study

Countries

Egypt

Contacts

Primary ContactF abukraa Obstetrics and Gynecology, MSD
fda2017@yahoo.com001149733132
Backup ContactS sayed Professor Obstetrics and Gynecology, phD
abokrafatma@gmail.com01224227779

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026