Hysteroscopic Lymphatic Mapping for Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00671606
Recruitment Status : Terminated (Slow accrual.)
First Posted : May 5, 2008
Results First Posted : July 27, 2011
Last Update Posted : May 27, 2016
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Endometrial Cancer
Intervention: Procedure: Intraoperative Lymphatic Mapping

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: 4/28/2008 to 5/4/2010. All participants were recruited at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Intraoperative Lymphatic Mapping Intraoperative sentinel lymph node identification (lymphatic mapping)

Participant Flow:   Overall Study
    Intraoperative Lymphatic Mapping

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Intraoperative Lymphatic Mapping Intraoperative sentinel lymph node identification (lymphatic mapping)

Baseline Measures
   Intraoperative Lymphatic Mapping 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (49 to 65) 
[Units: Participants]
Female   5 
Male   0 
Region of Enrollment 
[Units: Participants]
United States   5 

  Outcome Measures

1.  Primary:   Sentinel Node Identification Rate   [ Time Frame: 15-20 minute procedure prior to/during routine surgery for identifying the sentinel nodes ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination due to low detection rate of sentinel lymph nodes in the five participants.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Michael Frumovitz, ND/Assistant Professor
Organization: UT MD Anderson Cancer Center

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00671606     History of Changes
Other Study ID Numbers: 2007-0206
First Submitted: April 29, 2008
First Posted: May 5, 2008
Results First Submitted: June 30, 2011
Results First Posted: July 27, 2011
Last Update Posted: May 27, 2016