Sentinel Node Detection in Endometrial Cancer: A Consolid... | NCT03838055

Studies
Sentinel Node Detection in Endometrial Cancer: A Consolidation Study on Detection Rates of Metastatic Disease

NCT03838055

Sponsor

Region Skane

Status

Unknown status

Last Update Posted

Feb 12, 2019Actual

Enrollment

362Estimated

Phase

Not Applicable

Conditions

Sentinel Lymph Node
Endometrial Cancer
Lymphedema

Interventions

Injection of tracer ( ICG) and detection of sentinel lymph nodes

Countries

Sweden

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2019Estimated

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Dec 21, 2018

First Submission Date that Met QC Criteria

Feb 8, 2019

First Posted Date

Feb 12, 2019Actual

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

Feb 8, 2019

Last Update Posted Date

Feb 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluation of removal of Sentinel lymph nodes only for detection of pelvic lymph node metastases in high risk and low risk endometrial cancer.

Detailed Description

Consecutive patients with- and low risk endometrial cancer will be approached for eligibility for inclusion in a study evaluating the detection rates of pelvic metastatic disease by detection and removal of Sentinel lymph nodes only, i.e with no further lymphadenectomy.

A re-staging will be performed in case of metastatic Sentinel lymph nodes to guide adjuvant treatment.

The detection rate will be evaluated from a non-inferiority perspective against the expected rate of nodal metastases based on detailed final histological data.

Adverse events related the intervention ( Injection of tracer (ICG) and removal of sentinel nodes), time for the intervention, and an objective evaluation of lymphatic complications (lymphoedema) will be performed in addition to the use of a validated lymphoedema QOL questionnaire.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

362Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SLN only	Experimental	Pelvic SLN's defined by ICG injected cervically	Procedure: Injection of tracer ( ICG) and detection of sentinel lymph nodes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Injection of tracer ( ICG) and detection of sentinel lymph nodes	Procedure	Pelvic SLN's defined by ICG injected cervically	SLN only

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection rate of pelvic metastatic disease in endometrial cancer	The detection rate will be evaluated from a non-inferiority perspective based on a null-hypothesis of 4% less than an expected rate of 12% nodal metastases	3 years from start inclusion with an interim analysis after 150 patients
Operative time used for the study intervention ( injection of ICG and identification and removal of sentinel lymph nodes	Exact measurements of time allocated for the SLN procedure as such.	3 years from start inclusion

Secondary Outcomes

Measure	Description	Time Frame
Incidence of lymphedema after removal of sentinel lymph nodes	Objective measurement lymphedema defined by of leg volume before and after surgery	4 years including at least one year follow up
intraoperative adverse events associated with the study intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women of age 18 years and older at the time of informed consent.
Women with a pathologically proven endometrial carcinoma of any histologic subtype or grade, clinically stage I-II planned for primary surgery
A uterine size allowing minimally invasive surgery
Women must be able to understand and sign an informed consent in Swedish language.
Absence of any exclusion criteria

Exclusion Criteria:

Non consenting patients
Ongoing pregnancy
Inability to understand written and/or oral study information
WHO performance status or conditions contraindicating adjuvant oncological treatment (WHO III or more)
Previous lower limb lymphedema ( only for the lymphedema part of study)
Evidence of locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography.
Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion.
Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion
Allergy to Iodine
Patients with a known liver disease
Patients with a bleeding disorder or mandatory antithrombotic treatment.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jan Persson, Ass prof	Contact	0046733522080		jan.persson@med.lu.se
Michele Bollino, MD	Contact	0046723059274		michele.bollino@med.lu.se

Overall Officials

Name	Affiliation	Role
Jan Persson, Ass Prof	RegionSkane, department of OB&G, Skåne university hospital, Lund	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gynecology and Obstetrics		Lund		22185	Sweden

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 6, 2019	Feb 6, 2019	Prot_SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D016889	Endometrial Neoplasms
D008209	Lymphedema

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