NCT02560571

Brief Summary

The study evaluates pre-operative prediction of the risk for lymph nodes involvement in endometrial cancer patients. Patients will undergo ultrasound exam (bi and three dimensional) and biomarker test - Ca 125, in addition to routine physical and laboratory exams, before surgery. The sonographic evaluation will include endometrial characteristics and myometrial invasion, pelvic findings and enlarged lymph nodes.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

September 21, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

5 years

First QC Date

September 21, 2015

Last Update Submit

September 18, 2016

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

  • number of participants with positive nodes

    4 weeks after surgery (4-6 weeks from enrollment)

Study Arms (1)

all patients

EXPERIMENTAL

all study patients will undergo ultrasound and blood test

Device: ultrasoundOther: blood test

Interventions

ultrasoundDEVICE
all patients
blood testOTHER
all patients

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Endometrial cancer patients
  • Surgical candidates

You may not qualify if:

  • Fertility preservation therapy
  • Contraindication for surgery
  • Stage 2 and higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir medical center

Kfar Saba, Israel

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

UltrasonographyHematologic Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisClinical Laboratory TechniquesInvestigative Techniques

Central Study Contacts

yfat kadan, md

CONTACT

972-9-7471575yfat_ka@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 25, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2020

Last Updated

September 20, 2016

Record last verified: 2016-09

Locations

IL(1)