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Lymph Node Counts in Endometrial Cancer Staging

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ClinicalTrials.gov Identifier: NCT02335775
Recruitment Status : Completed
First Posted : January 12, 2015
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date December 15, 2014
First Posted Date January 12, 2015
Last Update Posted Date January 21, 2016
Study Start Date July 2008
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 7, 2015)
  • Total gross node identification [ Time Frame: 0-14 days post op ]
  • Percentage of lymph nodes showing metastatic cancer (%NM) [ Time Frame: 0-14 days post op ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02335775 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Lymph Node Counts in Endometrial Cancer Staging
Official Title A Prospective Study of the Impact of Surgical and Pathologic Tissue Sampling Methods on Lymph Node Counts and Detection of Lymph Node Metastasis in Endometrial Cancer Staging
Brief Summary

The purposes of this study are to determine whether total lymph node count or the percentage of identified nodes with metastatic disease are influenced by (1) the method of categorizing tissue specimens or (2) the techniques of pathologic processing following lymphadenectomy.

Patients with newly diagnosed endometrial carcinoma of high risk histologic type or uterine carcinosarcoma whose risk of LN metastasis exceeds 15% will be enrolled on this study. Patients will undergo staging to include hysterectomy and selective lymphadenectomy as per the clinical judgment of the primary Gynecologic Oncologist. Type of hysterectomy and the extent and distribution of lymphadenectomy is at the discretion of the surgeon. All patients will be scheduled for surgical staging. Each subject will have lymph nodes harvested on one side divided into specific basins, and on the contralateral side classified only as "pelvic" or "aortic". Surgical node specimens in the operating room will be labeled by (1) specific nodal basins on the randomly determined side as "external iliac", "obturator", "common iliac", "aortic", or "high aortic" and by (2) "pelvic" versus "aortic" (common iliac nodes will be considered as part of the "pelvic" specimen) on the contralateral side.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Woman over the age of 18 diagnosed with grade 3, clear cell, serous or sarcoma types of endometrial cancer
Condition Endometrial Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 7, 2015)
120
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Uterine cancer with one of the following pathologies: serous, clear cell, sarcoma or grade 3 differentiation
  • surgical candidate

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02335775
Other Study ID Numbers Pro00008993
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Duke University
Study Sponsor Duke University
Collaborators Not Provided
Investigators Not Provided
PRS Account Duke University
Verification Date January 2016