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Nodal Staging Techniques for Endometrial Cancer
Phase 3
Waitlist Available
Led By Frederick Ueland, MD
Research Sponsored by Frederick R. Ueland, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Life expectancy (estimated survival) of at least 6 months
No clinical evidence of extra-uterine disease on pre-operative evaluation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will compare the recurrence-free survival rates of women with endometrial cancer treated with selective versus sentinel node surgical staging.
Who is the study for?
Women over 18 with a specific type of endometrial cancer that hasn't spread outside the uterus can join. They should be able to have surgery, understand and sign consent forms, and not have had certain treatments for this cancer recently. Women who are pregnant or breastfeeding, or those with other serious health issues or another recent cancer aren't eligible.Check my eligibility
What is being tested?
The trial is testing two surgical methods for checking if endometrial cancer has spread to lymph nodes: selective staging versus sentinel node procedure. The goal is to see which method is better at preventing the cancer from coming back without spreading.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with surgery such as pain, infection, bleeding, blood clots, damage to nearby organs and tissues. There might also be allergic reactions related to the use of tracers in sentinel node procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are expected to live for at least 6 more months.
Select...
There is no sign of disease outside of the uterus based on the tests done before surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recurrence-free survival rate
Secondary outcome measures
Concordance of SELECTIVE and SENTINEL NODE surgical staging with final pathology
Disease-specific survival rate
Overall patient survival rate
+3 moreOther outcome measures
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
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Sentinel Node Surgical StagingExperimental Treatment1 Intervention
Group II: Selective Surgical StagingExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sentinel node procedure
2014
N/A
~260
Find a Location
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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently receiving chemotherapy, hormone therapy, or immunotherapy for your illness.You have had or currently have another type of cancer that could affect the safety or effectiveness of the experimental treatment.You have a known allergy to iodine, indigocyanine green (ICG), or similar substances.The disease has spread outside the uterus, and there are signs of suspicious lymph nodes in the aorta or groin area.There is no sign of disease outside of the uterus based on the tests done before surgery.You are expected to live for at least 6 more months.
Research Study Groups:
This trial has the following groups:- Group 1: Sentinel Node Surgical Staging
- Group 2: Selective Surgical Staging
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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