NCT03459976

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

January 25, 2019

Status Verified

March 1, 2018

Enrollment Period

1.3 years

First QC Date

March 4, 2018

Last Update Submit

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

Diagnostic Test: evaluate serum level HE4 in endometrial cancer

Interventions

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

2 groups

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

RECRUITING

Ain Shams University

Cairo, Abbasyia, +20, Egypt

RECRUITING

Ain Shams University

Cairo, Egypt

RECRUITING

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.

Related Links

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • M Elhafeez Assistant Professor Obstetrics and Gy, phD

    Obstetrics and Gynecology

    STUDY DIRECTOR
  • H Fathy Assistant Professor Obstetrics and Gy, phD

    ASU

    STUDY DIRECTOR

Central Study Contacts

F abukraa Obstetrics and Gynecology, MSD

CONTACT

S sayed Professor Obstetrics and Gynecology, phD

CONTACT

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

Locations