Endometrial CancerNCT02834988
Sentinel Lymph Node Dissection (SLND) in Patients With Apparent Early Stage Endometrial Cancer
An observational study of Endometrial Cancer, run by University of Miami at 1 site in United States.
Trial summary
The investigators hypothesize that SLND (unlike lymphadenectomy) decreases complications such as hemorrhage, lower extremity lymphedema and lymphocyst formation while enhancing quality of life in EC patients with low risk for nodal involvement. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2016to 10 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All of the patients enrolled on this trial are those who were scheduled to have their sentinel lymph nodes (SLN) removed standard of care.
Who may be able to join
- Patients must have histologically and/or cytologically confirmed endometrial cancer.
- Clinically apparent early stage endometrial cancer (i.e. disease confined to the uterus on preoperative work up).
- Patient has already scheduled an SLND surgery with treating physician.
- Females aged 18 years or older.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Patients with lymphadenopathy and/or evidence of metastases, either clinically palpable and/or on preoperative radiological imaging.
- Any preoperative adjuvant therapy for endometrial cancer (e.g. prior pelvic/abdominal radiotherapy (RT), chemotherapy, or retroperitoneal surgery).
- Patients may not be receiving any investigational agents.
- Pregnant or breastfeeding patients.
- Central Nervous System (CNS) restrictions (i.e. brain metastases).
- Any uncontrolled, intercurrent illness including but not limited to concomitant cancer, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Any serious medical or psychiatric illness/condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Validity of Sentinel Lymph Node Dissection (SLND) in Patients With Apparent Early Stage Endometrial Cancer (EC)
The investigators hypothesize that SLND (unlike lymphadenectomy) decreases complications such as hemorrhage, lower extremity lymphedema and lymphocyst formation while enhancing quality of life in EC patients with low risk for nodal involvement.
The investigators also hypothesize that SLND is an effective method of staging these patients. Studies have shown that SLN mapping identifies positive lymph nodes in women with newly diagnosed EC and this prognostic information obtained from SLND could guide selection of adjuvant treatment and improve overall survival.
Using SLND as an alternative to lymphadenectomy may also have additional medical and economic impacts, such as, decreasing prolonged hospitalization and associated costs by shortening overall surgery duration.
Read the detailed description
This is a non-interventional prospective chart review evaluating the clinical utility of SLND for detecting nodal metastasis of early stage endometrial cancer through data collection.
Patients who are scheduled to undergo standard-of-care (SOC) surgical staging for EC (sentinel lymph node dissection (SLND) via laparotomy, laparoscopy or robotic surgery, ±hysterectomy, ±bilateral salpingo-oophorectomy (BSO)) (pelvic and paraaortic lymphadenectomy may (or may not) also be performed in addition to SLND) will be approached for consent. After these patients have completed the above SOC surgical procedures, research staff will review and collect data from their medical charts. For the subset of these patients who are found, during their SOC surgery, to have positive nodes, research staff will continue to review and collect data from their medical charts after their standard of care follow-up visits with their oncologist
All of the patients enrolled on this trial are those who were scheduled to have their sentinel lymph nodes (SLN) removed; that is, all patients enrolled on this trial were consented by the research team because they were already scheduled to undergo sentinel lymph node dissection (SLND) via laparotomy, laparoscopy or robotic surgery, ±hysterectomy, ±bilateral salpingo-oophorectomy (BSO)). As part of this same SOC surgery, some of these patients also may have undergone pelvic and paraaortic lymphadenectomy in addition to SLND.
Within the research database built for this study, patients will be classified into risk strata (either low or high risk EC) as per the Modified Mayo Criteria. This classification will be partly based on the SOC post-surgical International Federation of Gynecology and Obstetrics (FIGO) staging. To establish progression-free survival (PFS) and overall survival (OS), research staff will intermittently perform medical chart reviews for only those patients with nodal metastasis for a minimum of 2 years (maximum of 6 years).
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial Cancer, Sentinel Lymph Node Dissection, SLND
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SLND Patients | Patients scheduled to have their sentinel lymph nodes removed, as part of standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLND Positivity Rate in Study Participants
The rate of SLND positivity rate overall and by risk group in patients with clinically apparent early-stage EC. EC patients will be classified as high or low risk group based on the modified Mayo Criteria (Mariani A 2008, Milam 2012).
Measured: Up to 6 years
Secondary outcomes (5)
Rate of NPV and FNPV of the SLND Procedure in Study Participants Who Undergo Partial or Full Lymphadenectomy.
The rate of the negative predictive value (NPV) and its complement the false negative predictive value (FNPV) rate of the SLND procedure in the subset of patients who also undergo partial or full lymphadenectomy. Negative Predictive Value (NPV) will be calculated by dividing the number of true negatives by the total number of patients with a negative SLN (false negatives and true negatives. False Negative Predictive Value (FNPV) rate will be calculated as the number false negatives divided by all patients without nodal metastasis (the number of false negatives and true negatives). FNPV rate is also known as the False Omission Rate (FOR); FNPV is the complement of NPV.
Measured: Up to 6 years
Proportion of Types of Lymph Node Metastases Described by SLND in Study Participants
Proportion of type(s) of lymph node metastases (isolated tumor cells (ITC), micrometastases, or macrometastases) described by SLND in true positive (TP) and false negative (FN) patients. True positives (TPs) are those patients with positive SLN who also have nodal metastasis. False negatives (FNs) are those patients with negative SLN who have nodal metastasis.
Measured: Up to 6 years
Comparison of Nodal Positivity Rates and the Pathologic Protocol for Sentinel Lymph Node Biopsies.
The investigators will compare nodal positivity rates using sentinel lymph node biopsies, and the pathologic protocol for sentinel lymph node biopsies. Positivity rates will be correlated to traditional pathologic factors, including grade, depth of invasion, lymphovascular space invasion, cervical involvement, and histology. Once this information is collected, the investigators will try to assess rates of sentinel lymph node positivity, and its association with these factors.
Measured: Up to 6 years
Rate of Progression-Free Survival in Study Participants With Nodal Metastasis
The rate of progression-free survival (PFS) in patients with nodal metastasis. Progression-Free Survival is defined as the length of time from the date of first dose of study treatment until date of disease progression or death due to any cause, whichever comes first.
Measured: Up to 6 years
Rate of Overall Survival in Study Participants With Nodal Metastasis
The rate of overall survival (OS) in patients with nodal metastasis. Overall survival is defined as the length of time from either the date of first dose of study treatment until death due to any cause.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study start28 Jul 2016
- Primary completion14 Jan 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Slomovitz, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834988
- Sponsor's protocol ID
- 20151012
- Status last verified
- Mar 2020
- First submitted
- 13 Jul 2016
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity of Sentinel Lymph Node Dissection (SLND) in Patients With Apparent Early Stage Endometrial Cancer (EC)
- ClinicalTrials.gov ID
- NCT02834988
- Acronym / sponsor ID
- 20151012
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial Cancer, Sentinel Lymph Node Dissection, SLND
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 28 Jul 2016 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 15 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that SLND (unlike lymphadenectomy) decreases complications such as hemorrhage, lower extremity lymphedema and lymphocyst formation while enhancing quality of life in EC patients with low risk for nodal involvement.
The investigators also hypothesize that SLND is an effective method of staging these patients. Studies have shown that SLN mapping identifies positive lymph nodes in women with newly diagnosed EC and this prognostic information obtained from SLND could guide selection of adjuvant treatment and improve overall survival.
Using SLND as an alternative to lymphadenectomy may also have additional medical and economic impacts, such as, decreasing prolonged hospitalization and associated costs by shortening overall surgery duration.
Detailed description
This is a non-interventional prospective chart review evaluating the clinical utility of SLND for detecting nodal metastasis of early stage endometrial cancer through data collection.
Patients who are scheduled to undergo standard-of-care (SOC) surgical staging for EC (sentinel lymph node dissection (SLND) via laparotomy, laparoscopy or robotic surgery, ±hysterectomy, ±bilateral salpingo-oophorectomy (BSO)) (pelvic and paraaortic lymphadenectomy may (or may not) also be performed in addition to SLND) will be approached for consent. After these patients have completed the above SOC surgical procedures, research staff will review and collect data from their medical charts. For the subset of these patients who are found, during their SOC surgery, to have positive nodes, research staff will continue to review and collect data from their medical charts after their standard of care follow-up visits with their oncologist
All of the patients enrolled on this trial are those who were scheduled to have their sentinel lymph nodes (SLN) removed; that is, all patients enrolled on this trial were consented by the research team because they were already scheduled to undergo sentinel lymph node dissection (SLND) via laparotomy, laparoscopy or robotic surgery, ±hysterectomy, ±bilateral salpingo-oophorectomy (BSO)). As part of this same SOC surgery, some of these patients also may have undergone pelvic and paraaortic lymphadenectomy in addition to SLND.
Within the research database built for this study, patients will be classified into risk strata (either low or high risk EC) as per the Modified Mayo Criteria. This classification will be partly based on the SOC post-surgical International Federation of Gynecology and Obstetrics (FIGO) staging. To establish progression-free survival (PFS) and overall survival (OS), research staff will intermittently perform medical chart reviews for only those patients with nodal metastasis for a minimum of 2 years (maximum of 6 years).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLND Patients | – | –Patients scheduled to have their sentinel lymph nodes removed, as part of standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All of the patients enrolled on this trial are those who were scheduled to have their sentinel lymph nodes (SLN) removed standard of care.
Key inclusion criteria (5 listed)
- Patients must have histologically and/or cytologically confirmed endometrial cancer.
- Clinically apparent early stage endometrial cancer (i.e. disease confined to the uterus on preoperative work up).
- Patient has already scheduled an SLND surgery with treating physician.
- Females aged 18 years or older.
- Ability to understand and willingness to sign a written informed consent document.
Key exclusion criteria (7 listed)
- Patients with lymphadenopathy and/or evidence of metastases, either clinically palpable and/or on preoperative radiological imaging.
- Any preoperative adjuvant therapy for endometrial cancer (e.g. prior pelvic/abdominal radiotherapy (RT), chemotherapy, or retroperitoneal surgery).
- Patients may not be receiving any investigational agents.
- Pregnant or breastfeeding patients.
- Central Nervous System (CNS) restrictions (i.e. brain metastases).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SLND Positivity Rate in Study Participants
Time frame: Up to 6 years
The rate of SLND positivity rate overall and by risk group in patients with clinically apparent early-stage EC. EC patients will be classified as high or low risk group based on the modified Mayo Criteria (Mariani A 2008, Milam 2012).
5 secondary outcomes
Rate of NPV and FNPV of the SLND Procedure in Study Participants Who Undergo Partial or Full Lymphadenectomy.
Time frame: Up to 6 years
Proportion of Types of Lymph Node Metastases Described by SLND in Study Participants
Time frame: Up to 6 years
Comparison of Nodal Positivity Rates and the Pathologic Protocol for Sentinel Lymph Node Biopsies.
Time frame: Up to 6 years
Rate of Progression-Free Survival in Study Participants With Nodal Metastasis
Time frame: Up to 6 years
Rate of Overall Survival in Study Participants With Nodal Metastasis
Time frame: Up to 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Slomovitz, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLND Positivity Rate in Study Participants (time frame: Up to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.