Endometrial CancerHE4NCT03459976
HE4 is a Beneficial Biomarker in Endometrial Cancer
An observational study of Endometrial Cancer, run by Ain Shams University at 3 sites in Egypt.
Trial summary
Evaluation of Serum level of Human Epididymis Secretory Protein 4 (HE4) in Endometrial Cancer and clinical significant it Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- evaluate serum level HE4 in endometrial cancer
- How many people
- 87 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 Dec 2017to 1 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Adult, Older adult
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.
Who may be able to join
- Age (40 - 70 yr old).
Who cannot join
- Age more than 70 yr and less than 40 yr.
- Abnormal cardiac hematological renal hepatic functions.
- Breast cancer or other malignancies.
- Concomitant benign and for malignant adnexal pathologies.
- Hormonal medication.
- Patient taking or having chemo-radiotherapy.
- Patients unfit for surgical intervention.
- Smoker.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites, 3 recruiting
- Recruiting
Ain Shams University
Cairo, Abbasyia, +20
F m abukraa, master, 01149733132, abukraafatma@med.asu.edu.eg
f m dabnon, master
- Recruiting
Ain Shams University
Cairo, Abbasyia, +20
F m dabnon, master, 01149733132, abukraafatma@med.asu.edu.eg
f m dabnon, master
- Recruiting
Ain Shams University
Cairo
F m dabnon, master, 01149733132, abukraafatma@med.asu.edu.eg
f m dabnon, master
About this study
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).
- Conditions
- Endometrial Cancer
- Being tested
- evaluate serum level HE4 in endometrial cancer
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluate serum level HE4 in endometrial cancerDiagnostic test
- HE4 in beignin endometrial diseases
- HE4 in endometrial cancer
| Study group | Role | What they receive |
|---|---|---|
| 2 groups | control group case group Receives: Diagnostic Test: evaluate serum level HE4 in endometrial cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
: 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
Measured: 1 yeare
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start1 Dec 2017
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, f m dabnon, Ain Shams University
- Investigators
- M Elhafeez Assistant Professor Obstetrics and Gy, phD, Study director, Obstetrics and GynecologyH Fathy Assistant Professor Obstetrics and Gy, phD, Study director, ASU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459976
- Sponsor's protocol ID
- HE4 in endometrial cancer
- Acronym
- HE4
- Status last verified
- Mar 2018
- First submitted
- 4 Mar 2018
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HE4 is a Beneficial Biomarker in Endometrial Cancer
- ClinicalTrials.gov ID
- NCT03459976
- Acronym / sponsor ID
- HE4 / HE4 in endometrial cancer
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 groups | – | Diagnostic Test: evaluate serum level HE4 in endometrial cancercontrol group case group |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Age (40 - 70 yr old).
Key exclusion criteria (8 listed)
- Age more than 70 yr and less than 40 yr.
- Abnormal cardiac hematological renal hepatic functions.
- Breast cancer or other malignancies.
- Concomitant benign and for malignant adnexal pathologies.
- Hormonal medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluate serum level HE4 in endometrial cancer1. HE4 in beignin endometrial diseases 2. HE4 in endometrial cancer | Diagnostic test | 2 groups |
Primary outcome
: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Results publication: PubMed 28374920Benati 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.
- endometrial cancerLink provided by the sponsor.
- endometrial cancerLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M Elhafeez Assistant Professor Obstetrics and Gy, phD study director
Obstetrics and Gynecology
H Fathy Assistant Professor Obstetrics and Gy, phD study director
ASU
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Ain Shams University at 3 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact F abukraa Obstetrics and Gynecology, MSD (001149733132, fda2017@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
: Evaluation of Serum Level of(HE4) in Benign Endometrial disease and Endometrial Cancer (time frame: 1 yeare). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03459976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.