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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00100 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000721346 | |||
| GOG-0270 | |||
| GOG-0270 | Other Identifier | NRG Oncology | |
| GOG-0270 | Other Identifier | CTEP | |
| U10CA180868 | U.S. NIH Grant/Contract | View source | |
| U10CA027469 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
This research trial studies patients with early-stage vulvar cancer undergoing sentinel lymph node dissection. Sentinel lymph node dissection may have fewer side effects than removing all lymph nodes. Observing patients undergoing sentinel lymph node dissection may help doctors confirm the safety of the procedure.
PRIMARY OBJECTIVES:
I. To prospectively observe patients who receive radiation +/- chemotherapy immediately after lymph node dissection to confirm the safety of this procedure.
OUTLINE:
Patients receive standard therapy including sentinel lymph node dissection. Patients are then observed to collect information about treatment and outcomes every 2 months for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation (observe patients undergoing SLN dissection) | Patients receive standard therapy including sentinel lymph node dissection. Patients are then observed to collect information about treatment and outcomes every 2 months for 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Observation | Other | Undergo observation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of sentinel lymph node dissection | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Slomovitz | NRG Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center at Saint Joseph's | Phoenix | Arizona | 85004 | United States | ||
| Saint Joseph's Hospital and Medical Center |
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| Phoenix |
| Arizona |
| 85013 |
| United States |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| Jackson Memorial Hospital-Holtz Children's Hospital | Miami | Florida | 33136 | United States |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | United States |
| Sudarshan K Sharma MD Limted-Gynecologic Oncology | Hinsdale | Illinois | 60521 | United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | United States |
| Mercy Health Saint Mary's | Grand Rapids | Michigan | 49503 | United States |
| Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | 49503 | United States |
| Mercy Health Mercy Campus | Muskegon | Michigan | 49444 | United States |
| Lakeland Community Hospital | Niles | Michigan | 49120 | United States |
| Spectrum Health Reed City Hospital | Reed City | Michigan | 49677 | United States |
| Lakeland Hospital | Saint Joseph | Michigan | 49085 | United States |
| Marie Yeager Cancer Center | Saint Joseph | Michigan | 49085 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Cancer Research for the Ozarks NCORP | Springfield | Missouri | 65804 | United States |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | United States |
| Women's Cancer Center of Nevada | Las Vegas | Nevada | 89169 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| Overlook Hospital | Summit | New Jersey | 07902 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Oklahoma Cancer Specialists and Research Institute-Tulsa | Tulsa | Oklahoma | 74146 | United States |
| University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania | 15232 | United States |
| Women and Infants Hospital | Providence | Rhode Island | 02905 | United States |
| Greenville Health System Cancer Institute-Faris | Greenville | South Carolina | 29605 | United States |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Carilion Clinic Gynecological Oncology | Roanoke | Virginia | 24016 | United States |
| Odette Cancer Centre- Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| ID | Term |
|---|---|
| D014846 | Vulvar Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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