Hysteroscopic Lymphatic Mapping for Endometrial Cancer

This study has been terminated.
(Slow accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00671606
First received: April 29, 2008
Last updated: April 16, 2012
Last verified: April 2012
Results First Received: June 30, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Endometrial Cancer
Intervention: Procedure: Intraoperative Lymphatic Mapping

  Participant Flow
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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
  Description
Intraoperative Lymphatic Mapping Intraoperative sentinel lymph node identification (lymphatic mapping)

Participant Flow:   Overall Study
    Intraoperative Lymphatic Mapping  
STARTED     5  
COMPLETED     5  
NOT COMPLETED     0  



  Baseline Characteristics
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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
  Description
Intraoperative Lymphatic Mapping Intraoperative sentinel lymph node identification (lymphatic mapping)

Baseline Measures
    Intraoperative Lymphatic Mapping  
Number of Participants  
[units: participants]
  5  
Age  
[units: years]
Median ( Full Range )
  56  
  ( 49 to 65 )  
Gender  
[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


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


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.  


Results Point of Contact:  
Name/Title: Dr. Michael Frumovitz, ND/Assistant Professor
Organization: UT MD Anderson Cancer Center
e-mail: tjohnsto@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00671606     History of Changes
Other Study ID Numbers: 2007-0206
Study First Received: April 29, 2008
Results First Received: June 30, 2011
Last Updated: April 16, 2012
Health Authority: United States: Institutional Review Board