Sentinel node procedure for Endometrial Cancer

University of Kentucky, Lexington, KY
Endometrial CancerSentinel node procedure - Procedure
Eligibility
18+
Female

Study Summary

This trial will compare the recurrence-free survival rates of women with endometrial cancer treated with selective versus sentinel node surgical staging.

Eligible Conditions
  • Endometrial Cancer

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
Sentinel Lymph Node (SLN) mapping
1
Focus Group
1
Tc-99m tilmanocept

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 5 years

5 years
Concordance of SELECTIVE and SENTINEL NODE surgical staging with final pathology
Disease-specific survival rate
Location patterns of nodal involvement associated with disease stage
Location patterns of nodal involvement associated with staging procedures
Number of metastatic lymph node(s) associated with disease stage
Number of metastatic lymph node(s) associated with staging procedures
Overall patient survival rate
Patient morbidity
Patient mortality
Patterns of nodal involvement associated with primary tumor cell type
Patterns of nodal involvement associated with primary tumor depth of invasion
Patterns of nodal involvement associated with primary tumor grade
Patterns of nodal involvement associated with primary tumor lesion size
Progression-free survival rate
Recurrence-free survival rate

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Sentinel Lymph Node (SLN) mapping
1
Focus Group
1
Tc-99m tilmanocept

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Selective Surgical Staging
1 of 2
Sentinel Node Surgical Staging
1 of 2

Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: Sentinel node procedure · No Placebo Group · Phase 3

Selective Surgical Staging
Procedure
Experimental Group · 1 Intervention: Selective staging · Intervention Types: Procedure
Sentinel Node Surgical Staging
Procedure
Experimental Group · 1 Intervention: Sentinel node procedure · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sentinel node procedure
2014
N/A
~260

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

Frederick R. Ueland, M.D.Lead Sponsor
4 Previous Clinical Trials
795 Total Patients Enrolled
2 Trials studying Endometrial Cancer
601 Patients Enrolled for Endometrial Cancer
Frederick Ueland, MDPrincipal InvestigatorUniversity of Kentucky
1 Previous Clinical Trials
15 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 6 more months.
References

Frequently Asked Questions

What is the Sentinel node procedure and what are its risks?

"There is some evidence suggesting that the Sentinel node procedure is effective and safe, as it has received a score of 3." - Anonymous Online Contributor

Unverified Answer

Are individuals currently being recruited for this experiment?

"The listing on clinicaltrials.gov verifies that this study is actively looking for patients to enroll. The trial was established on November 5th, 2021 and has since been edited December 27th, 2021. They are hoping to enroll 300 individuals at a single site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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