Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
Study NCT ID:
NCT01500512
Status:
UNKNOWN
Last Update Posted:
2021-09-30
First Post:
2011-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014846', 'term': 'Vulvar Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2011-12-24', 'studyFirstSubmitQcDate': '2011-12-24', 'lastUpdatePostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of sentinel lymph node dissection', 'timeFrame': 'Up to 2 years'}]}, 'conditionsModule': {'conditions': ['Stage I Vulvar Cancer', 'Stage II Vulvar Cancer', 'Stage III Vulvar Cancer', 'Vulvar Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To prospectively observe patients who receive radiation +/- chemotherapy immediately after lymph node dissection to confirm the safety of this procedure.\n\nOUTLINE:\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have squamous cell carcinoma with a depth invasion \\> 1 mm\n* 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\n* Localization and size of the tumor are such that peri-lesional injection of the tracers at three or four sites is possible\n* Preoperative imaging do not show enlarged (\\< 1.5 cm) suspicious nodes\n* Patients must sign informed consent\n\nExclusion Criteria:\n\n* Inoperable tumors with diameter \\> 4 cm\n* 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\n* Patients with multifocal tumors\n* Patients who are currently on an investigational drug for the treatment of vulvar cancer are excluded from participation in this trial'}, 'identificationModule': {'nctId': 'NCT01500512', 'acronym': 'GROINSS-V', 'briefTitle': 'Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection', 'organization': {'class': 'NETWORK', 'fullName': 'GOG Foundation'}, 'officialTitle': 'GROningen INternational Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study', 'orgStudyIdInfo': {'id': 'GOG-0270'}, 'secondaryIdInfos': [{'id': 'NCI-2012-00100', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000721346'}, {'id': 'GOG-0270'}, {'id': 'GOG-0270', 'type': 'OTHER', 'domain': 'NRG Oncology'}, {'id': 'GOG-0270', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180868', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180868', 'type': 'NIH'}, {'id': 'U10CA027469', 'link': 'https://reporter.nih.gov/quickSearch/U10CA027469', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observation (observe patients undergoing SLN dissection)', 'description': '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.', 'interventionNames': ['Other: Clinical Observation']}], 'interventions': [{'name': 'Clinical Observation', 'type': 'OTHER', 'description': 'Undergo observation', 'armGroupLabels': ['Observation (observe patients undergoing SLN dissection)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "University of Arizona Cancer Center at Saint Joseph's", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Saint Joseph's Hospital and Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine Health/Chao Family Comprehensive Cancer Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Jackson Memorial Hospital-Holtz Children's Hospital", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine-Sylvester Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60521', 'city': 'Hinsdale', 'state': 'Illinois', 'country': 'United States', 'facility': 'Sudarshan K Sharma MD Limted-Gynecologic Oncology', 'geoPoint': {'lat': 41.80086, 'lon': -87.93701}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Cancer Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Medical Center', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '49017', 'city': 'Battle Creek', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bronson Battle Creek', 'geoPoint': {'lat': 42.3173, 'lon': -85.17816}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': "Mercy Health Saint Mary's", 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health at Butterworth Campus', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49444', 'city': 'Muskegon', 'state': 'Michigan', 'country': 'United States', 'facility': 'Mercy Health Mercy Campus', 'geoPoint': {'lat': 43.23418, 'lon': -86.24839}}, {'zip': '49120', 'city': 'Niles', 'state': 'Michigan', 'country': 'United States', 'facility': 'Lakeland Community Hospital', 'geoPoint': {'lat': 41.82977, 'lon': -86.25418}}, {'zip': '49677', 'city': 'Reed City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health Reed City Hospital', 'geoPoint': {'lat': 43.87502, 'lon': -85.51005}}, {'zip': '49085', 'city': 'Saint Joseph', 'state': 'Michigan', 'country': 'United States', 'facility': 'Lakeland Hospital', 'geoPoint': {'lat': 42.10976, 'lon': -86.48002}}, {'zip': '49085', 'city': 'Saint Joseph', 'state': 'Michigan', 'country': 'United States', 'facility': 'Marie Yeager Cancer Center', 'geoPoint': {'lat': 42.10976, 'lon': -86.48002}}, {'zip': '49684', 'city': 'Traverse City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Munson Medical Center', 'geoPoint': {'lat': 44.76306, 'lon': -85.62063}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota/Masonic Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Cancer Research for the Ozarks NCORP', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'CoxHealth South Hospital', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '89169', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': "Women's Cancer Center of Nevada", 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Morristown Medical Center', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '07902', 'city': 'Summit', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Overlook Hospital', 'geoPoint': {'lat': 40.71562, 'lon': -74.36468}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Lineberger Comprehensive Cancer Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Riverside Methodist Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74146', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Cancer Specialists and Research Institute-Tulsa', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Cancer Institute (UPCI)', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Women and Infants Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Health System Cancer Institute-Faris', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern/Simmons Cancer Center-Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '24016', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Carilion Clinic Gynecological Oncology', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Odette Cancer Centre- Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Brian Slomovitz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NRG Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynecologic Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}