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:
Gynecologic Oncology Group
Organization:
Study Overview
Official Title:
GROningen INternational Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GROINSS-V
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-00100 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000721346 | None | None | View | |
| GOG-0270 | None | None | View | |
| GOG-0270 | OTHER | NRG Oncology | View | |
| GOG-0270 | OTHER | CTEP | View | |
| U10CA180868 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10CA027469 | NIH | None | https://reporter.nih.gov/quic… | View |