Pre-operative Studies for Prediction of Lymph Nodes Invol... | NCT02560571

Studies
Pre-operative Studies for Prediction of Lymph Nodes Involvement in Endometrial Cancer Patients

NCT02560571

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Sep 20, 2016Estimated

Enrollment

200Estimated

Phase

Phase 2

Conditions

Endometrial Cancer

Interventions

ultrasound
blood test

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Oct 2020Estimated

Completion Date

Not provided

First Submitted Date

Sep 21, 2015

First Submission Date that Met QC Criteria

Sep 24, 2015

First Posted Date

Sep 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2016

Last Update Posted Date

Sep 20, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
all patients	Experimental	all study patients will undergo ultrasound and blood test	Device: ultrasound Other: blood test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound	Device		all patients
blood test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of participants with positive nodes		4 weeks after surgery (4-6 weeks from enrollment)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Endometrial cancer patients
Surgical candidates

Exclusion Criteria:

Fertility preservation therapy
Contraindication for surgery
Stage 2 and higher

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
yfat kadan, md	Contact	972-9-7471575		yfat_ka@clalit.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir medical center	Recruiting	Kfar Saba			Israel

Condition Browse Module

MeSH Terms

ID	Term
D016889	Endometrial Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014463	Ultrasonography
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D019411	Clinical Laboratory Techniques

Browse Leaves

Not provided

Browse Branches

Not provided