Survey on Lymphedema After Sentinel Lymph Node Biopsy in People With Cervical or Vulvar Cancer
NCT ID: NCT05255393
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
111 participants
OBSERVATIONAL
2022-02-15
2025-11-19
Brief Summary
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Please note that, during this study, the researchers will collect information from a questionnaire completed by people who had SLN and LND+/- SLN during surgery for early-stage cervical or vulvar cancer. No form of treatment will be provided as part of the study, and no investigational tests or procedures will be performed.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Standard lymphadenectomy(LND) with sentinel lymph node mapping (SLN)
Patients will receive up to two mailings or messages and two phone calls if they do not respond. Self-addressed, stamped envelopes will be provided for return of questionnaires.
No other interventions are planned.
Questionnaires
A 13-item questionnaire specific to LEL, developed and validated by investigators at the Mayo Clinic.
The EORTC QLQ-C30 is a 30-item questionnaire designed to assess the quality of life of cancer patients.
The EORTC Quality of Life - Cervical Cancer Module.
Standard lymphadenectomy(LND) alone
Patients will receive up to two mailings or messages and two phone calls if they do not respond. Self-addressed, stamped envelopes will be provided for return of questionnaires.
No other interventions are planned.
Questionnaires
A 13-item questionnaire specific to LEL, developed and validated by investigators at the Mayo Clinic.
The EORTC QLQ-C30 is a 30-item questionnaire designed to assess the quality of life of cancer patients.
The EORTC Quality of Life - Cervical Cancer Module.
Interventions
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Questionnaires
A 13-item questionnaire specific to LEL, developed and validated by investigators at the Mayo Clinic.
The EORTC QLQ-C30 is a 30-item questionnaire designed to assess the quality of life of cancer patients.
The EORTC Quality of Life - Cervical Cancer Module.
Eligibility Criteria
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Inclusion Criteria
°Early stage: Stage 1-2
* Underwent primary surgery at our institution between January 2006 and January 2022.
* Alive at the time of study activation
* English comprehension
* Capable of providing informed consent
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Mario Leitao, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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22-002
Identifier Type: -
Identifier Source: org_study_id
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