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Status unknownNCT03459976HE4Updated Jan 25, 2019

HE4 is a Beneficial Biomarker in Endometrial Cancer

An observational study in Endometrial Cancer, sponsored by Ain Shams University. Status unknown at 3 sites in Egypt. Open to female participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-01-25.

Sponsored by Ain Shams University · Observational

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
87
Ages
40 Years to 70 Years
Sex
Female
01

Study summary

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

Read the 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).

02

Conditions studied

  • Endometrial Cancer
03

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Female
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.

Inclusion criteria

Age (40 - 70 yr old).

Exclusion criteria

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.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
87 participants (estimated)
Patient registry
No

Groups and cohorts

  • 2 groups

    control group case group

    Diagnostic Test: evaluate serum level HE4 in endometrial cancer

Interventions

  • Diagnostic testevaluate serum level HE4 in endometrial cancer

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

05

What researchers measure

Primary outcomes

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

    * 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

    Time frame: 1 yeare

06

Study locations

3 of 3 sites recruiting
  • Ain Shams University
    Cairo, Abbasyia +20, Egypt
    Recruiting
  • Ain Shams University
    Cairo, Abbasyia +20, Egypt
    Recruiting
  • Ain Shams University
    Cairo, Egypt
    Recruiting
07

References and documents

Publications

  • 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. PubMed 28374920 ↗
08

Registry details

Key details

Study ID
NCT03459976
Lead sponsor
Ain Shams University
Responsible party
f m dabnon (dr.fatma mohamed dapnon abuktaa, Ain Shams University) — Principal investigator
First posted
Mar 9, 2018
Start date
Dec 1, 2017
Primary completion
Apr 1, 2019 (estimated)
Completion
Apr 1, 2019 (estimated)
Last update
Jan 25, 2019

Study contacts

F abukraa Obstetrics and Gynecology, MSD
Contact
fda2017@yahoo.com
001149733132
S sayed Professor Obstetrics and Gynecology, phD
Contact
abokrafatma@gmail.com
01224227779
M Elhafeez Assistant Professor Obstetrics and Gy, phD
study director · Obstetrics and Gynecology
H Fathy Assistant Professor Obstetrics and Gy, phD
study director · ASU

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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