Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

HE4 is a Beneficial Biomarker in Endometrial Cancer (HE4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03459976
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
f m dabnon, Ain Shams University

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

Condition or disease Intervention/treatment
Endometrial Cancer Diagnostic Test: evaluate serum level HE4 in endometrial cancer

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).


Layout table for study information
Study Type : Observational
Estimated Enrollment : 87 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: HE4 is a Beneficial Biomarker in Endometrial Cancer
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : April 1, 2019

Group/Cohort Intervention/treatment
2 groups
control group case group
Diagnostic Test: evaluate serum level HE4 in endometrial cancer
  1. HE4 in beignin endometrial diseases
  2. HE4 in endometrial cancer




Primary Outcome Measures :
  1. : Evaluation of Serum Level of(HE4) in Benign Endometrial disease and Endometrial Cancer [ Time Frame: 1 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459976


Contacts
Layout table for location contacts
Contact: F abukraa Obstetrics and Gynecology, MSD 001149733132 fda2017@yahoo.com
Contact: S sayed Professor Obstetrics and Gynecology, phD 01224227779 abokrafatma@gmail.com

Locations
Layout table for location information
Egypt
Ain Shams University Recruiting
Cairo, Abbasyia, Egypt, +20
Contact: F m abukraa, master    01149733132    abukraafatma@med.asu.edu.eg   
Principal Investigator: f m dabnon, master         
Ain Shams University Recruiting
Cairo, Abbasyia, Egypt, +20
Contact: F m dabnon, master    01149733132    abukraafatma@med.asu.edu.eg   
Principal Investigator: f m dabnon, master         
Ain Shams University Recruiting
Cairo, Egypt
Contact: F m dabnon, master    01149733132    abukraafatma@med.asu.edu.eg   
Principal Investigator: f m dabnon, master         
Sponsors and Collaborators
Ain Shams University
Investigators
Layout table for investigator information
Study Director: M Elhafeez Assistant Professor Obstetrics and Gy, phD Obstetrics and Gynecology
Study Director: H Fathy Assistant Professor Obstetrics and Gy, phD ASU

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 10.1002/jcla.22223
DJ-1; HE4; PARK7; endometrial cancer

Publications of Results:
Layout table for additonal information
Responsible Party: f m dabnon, dr.fatma mohamed dapnon abuktaa, Ain Shams University
ClinicalTrials.gov Identifier: NCT03459976     History of Changes
Other Study ID Numbers: HE4 in endometrial cancer
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: March 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female