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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04291612
Registration number
NCT04291612
Ethics application status
Date submitted
27/02/2020
Date registered
2/03/2020
Date last updated
27/10/2023
Titles & IDs
Public title
Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease
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Scientific title
SEntinel Lymph Node Endometrial Cancer Trial: A Prospective Multicenter International Single-Arm Observational Trial (SELECT)
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Secondary ID [1]
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20-067
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer
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Endometrioid Adenocarcinoma
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Endometrial Cancer Stage I
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Cancer
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Ovarian and primary peritoneal
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Physical exam
Part 1 - Participants will have endometrioid adenocarcinoma histological diagnosis with planned surgical treatment including hysterectomy in combination with SLN biopsy.
Part 2 - Participants will have undergone surgery and bilateral sentinel lymph node mapping (negative for malignancy)
Other interventions: Physical exam
Part 2 participants will be prospectively followed clinically for relapse for 30 months from the date of surgery for physical examination at post-ops visits.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of pelvic/non-vaginal recurrence at 36 months
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Assessment method [1]
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Participants will be assessed every 6 (+/- 2) months for 36 months through routine physical examination
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Timepoint [1]
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36 months
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Eligibility
Key inclusion criteria
Screening
- ECOG performance status 0-1 or KPS = 70%
- Age = 18 years
- Endometrioid adenocarcinoma histologic diagnosis on endometrial biopsy or dilatation
and curettage
- No evidence of extrauterine disease, or suspicious pelvic lymph nodes, or distant
metastases, or cervical invasion on pre-operative conventional imaging studies (Pelvic
+/- Abdomen CT or MRI or sonogram, or body PET scan) and physical examination (uterine
confined by exam and imaging )
- Suitable candidate for surgery
- Planned surgical treatment including hysterectomy in combination with SLN biopsy and a
bilateral salpingo-oophorectomy
- No history of second primary cancer (invasive or in situ) within the past 5 years, not
including non-melanoma skin cancer
- Approved and signed informed consent
- No history of neoadjuvant chemotherapy or radiotherapy for endometrial cancer
- No history of prior pelvic or abdominal radiotherapy
Screening
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Extrauterine disease, or gross lymph node involvement, or cervical invasion suspected
on pre-operative imaging studies and physical examination (disease not uterine
confined clinical stage > I)
- Contraindication for SLN mapping
- The planned treatment is not surgery, or the surgical treatment does not include
hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy
Eligibility Inclusion Criteria
Patients will be classified in the study cohort (part 2; n=182) according to surgical
treatment received, final post hysterectomy and staging pathologic report, and planned
adjuvant treatment. The inclusion criteria are specified below.
Study Cohort (n=182)
A patient will be enrolled in the study cohort if all the following criteria are met:
- At surgery, the patient must undergo:
- Hysterectomy
- Bilateral salpingo-oophorectomy, unless already previously performed
- Bilateral pelvic SLN mapping (bilateral sentinel nodes are negative for
malignancy)
- On the final pathologic report, the patient must have a diagnosis of:
- Stage I intermediate-risk endometrial endometrioid cancer (Grade 1 or Grade 2
with = 50% myometrial invasion or Grade 3 with <50% myometrial invasion,
including non-invasive disease)
- Negative pelvic peritoneal cytology
- Adjuvant treatment as recommended by the multidisciplinary team must be as follows:
- No adjuvant treatment, or
- Intravaginal radiation only
Eligibility Exclusion Criteria
- There is intra-operative detection of extra-uterine disease or grossly involved lymph
nodes
- Presence of any positive pelvic nodes including micrometastasis and isolated tumor
cells (ITC)
- Hysterectomy is not performed
- Bilateral salpingo-oophorectomy is not performed, unless already previously performed
- Failed unilateral or bilateral SLN mapping
- Patient undergoes a complete unilateral or bilateral pelvic lymphadenectomy
- Patient undergoes a radical type C hysterectomy
- Stage IA endometrioid cancer Grade1 or 2 and myometrial invasion <50%
- Stage IB Grade 3 endometrioid cancer
- Non-endometrioid histology: Serous, clear cell, carcinosarcoma, undifferentiated, or
de-differentiated histology noted on final hysterectomy pathology
- Empty unilateral or bilateral sentinel lymph nodal packet(s)
- Positive peritoneal cytology
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/02/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
26/02/2024
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Actual
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Sample size
Target
1400
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Minnesota
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New Jersey
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New York
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Pennsylvania
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Texas
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Czechia
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Prague
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Italy
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Ferrera
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Italy
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Milan
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Italy
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Roma
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Italy
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Udine
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Norway
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State/province [13]
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Oslo
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Funding & Sponsors
Primary sponsor type
Other
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Name
Memorial Sloan Kettering Cancer Center
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is being done to find out how often endometrial cancer recurs after the standard
treatment as well as how often the standard treatment results in a lymphedema.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04291612
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Nadeem Abu-Rustum, MD
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Address
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Memorial Sloan Kettering Cancer Center
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Nadeem Abu-Rustum, MD
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Address
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Phone
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212-639-7051
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04291612
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