Observation In Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-007759
NCT ID: NCT01500512
Sponsor Protocol Number: GOG-0270
About this study
A prospective observational study will be performed in patients with early stage SCC (diameter < 4cm) of the vulva without suspicious lymph nodes at palpation or radiology and planned for surgery (radical local excision or radical vulvectomy in combination with sentinel node procedure).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria: - Patients must have squamous cell carcinoma with a depth invasion > 1 mm - Patients must have T1 or T2 tumors (International Federation of Gynecology and Obstetrics[FIGO] staging), < 4 cm, not encroaching in urethra, vagina, or anus with clinically negative inguinofemoral lymph nodes - Localization and size of the tumor are such that peri-lesional injection of the tracers at three or four sites is possible - Preoperative imaging do not show enlarged (< 1.5 cm) suspicious nodes - Patients must sign informed consent Exclusion Criteria: - Inoperable tumors with diameter > 4 cm - Patients with inguinofemoral lymph nodes, at palpation clinically suspect for metastases, at radiology enlarged (> 1.5 cm) suspicious groin nodes and with cytologically proven inguinofemoral lymph node metastases - Patients with multifocal tumors - Patients who are currently on an investigational drug for the treatment of vulvar cancer are excluded from participation in this trial
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jamie Bakkum-Gamez, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available