HE4 is a Beneficial Biomarker in Endometrial Cancer
HE4
1 other identifier
observational
87
1 country
3
Brief Summary
Evaluation of Serum level of Human Epididymis Secretory Protein 4 (HE4) in Endometrial Cancer and clinical significant it
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2017
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 4, 2018
CompletedFirst Posted
Study publicly available on registry
March 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedJanuary 25, 2019
March 1, 2018
1.3 years
March 4, 2018
January 24, 2019
Conditions
Outcome Measures
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
1 yeare
Study Arms (1)
2 groups
control group case group
Interventions
1. HE4 in beignin endometrial diseases 2. HE4 in endometrial cancer
Eligibility Criteria
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.
You may qualify if:
- Age (40 - 70 yr old).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Ain Shams University
Cairo, Abbasyia, +20, Egypt
Ain Shams University
Cairo, Abbasyia, +20, Egypt
Ain Shams University
Cairo, Egypt
Related Publications (1)
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.
PMID: 28374920RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
M Elhafeez Assistant Professor Obstetrics and Gy, phD
Obstetrics and Gynecology
- STUDY DIRECTOR
H Fathy Assistant Professor Obstetrics and Gy, phD
ASU
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- dr.fatma mohamed dapnon abuktaa
Study Record Dates
First Submitted
March 4, 2018
First Posted
March 9, 2018
Study Start
December 1, 2017
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
January 25, 2019
Record last verified: 2018-03