NCT02988765

Brief Summary

Vulvar cancer is a rare and very aggressive cancer, mainly spreading through lymphatics, in which the preoperative evaluation is critical to address surgery between sentinel node biopsy or radical groin lymphadenectomy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 9, 2016

Status Verified

December 1, 2016

Enrollment Period

2 years

First QC Date

December 2, 2016

Last Update Submit

December 7, 2016

Conditions

Vulvar Cancer

Keywords

vulvar canceringuinal lymph nodelymph node statuscytologycore biopsy

Outcome Measures

Primary Outcomes (2)

  • Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of ultrasound morphometry (USM) in the prediction of groin lymph node status

    within the first 30 days after surgery

  • Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of fine needle aspiration in the prediction of groin lymph node status

    within the first 30 days after surgery

Study Arms (1)

Invasive vulvar cancer (IVC)

EXPERIMENTAL

* Vulvar carcinoma (stromal infiltration \> 1 mm) * Histotypes different from squamous cells carcinomas are included

Procedure: Groin ultrasound +/- fine needle aspiration

Interventions

Groin ultrasound +/- fine needle aspirationPROCEDURE

Preoperative ultrasound morphometry (USM) of the inguino-femoral lymph nodes (IFLN). The FNAC and/or FNAB is performed in case of suspicious nodes, if at least one of the selected criteria is relieved during ultrasound

Invasive vulvar cancer (IVC)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Invasive vulvar cancer (all infiltrating histotypes)
  • Age \>18 years

You may not qualify if:

  • patient unable to follow the study procedures
  • patient with major depressive disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Gynecologic Oncology/Fondazione Policlinico Gemelli

Rome, Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsVulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 9, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 9, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)