Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02988765
Other study ID # Morpho-Node
Secondary ID
Status Recruiting
Phase N/A
First received December 2, 2016
Last updated December 7, 2016
Start date December 2016
Est. completion date December 2018

Study information

Verified date December 2016
Source Catholic University of the Sacred Heart
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

In the absence of clearly an specific guidelines on preoperative vulvar cancer assessment, the investigators decided to better investigate the role of ultrasound in groin nodes evaluation through the study 10 sonographic features of suspicion for nodal involvement:

- globular shape (loss of the normal elliptical form)

- long/short axis ratio

- cortical/medulla ratio

- cortical focal bulging or thickening

- hilum anomalies

- inhomogeneous echostructure

- intranodal deposits

- extracapsular spread

- grouping

- vascularization

The standard of comparison is histopathology.

The prospectively evaluation of these parameters will be obtained on the enrolled patients.

The investigators also provided the retrospective review - by specialized staff - of ultrasound images collected in archives associated with information relating to the cyto/histological procedures (performed in case of suspicious lymph nodes) in patients who underwent surgical treatment in the last five years at the study center.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Invasive vulvar cancer (all infiltrating histotypes)

- Age >18 years

Exclusion Criteria:

- patient unable to follow the study procedures

- patient with major depressive disorder

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
Groin ultrasound +/- fine needle aspiration
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

Locations

Country Name City State
Italy Division of Gynecologic Oncology/Fondazione Policlinico Gemelli Rome

Sponsors (1)

Lead Sponsor Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
See also
  Status Clinical Trial Phase
Completed NCT00543543 - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) Phase 3
Completed NCT02096783 - Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer N/A
Completed NCT01986725 - The Impact of the "WOMAN-PRO II Program" on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence Phase 2
Completed NCT03158220 - Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) Phase 3
Completed NCT05372016 - Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Phase 3
Recruiting NCT05743517 - Physical Activity Intervention Among Older Women With Gynecologic Cancers (Fit4Treatment) N/A
Recruiting NCT05914974 - Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
Recruiting NCT05979610 - Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies Phase 2
Recruiting NCT04708470 - A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers Phase 1/Phase 2
Active, not recruiting NCT04357873 - Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations Phase 2
Completed NCT00520598 - Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001) Phase 2
Completed NCT00551187 - A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED) Phase 2
Terminated NCT00669422 - ChemoFx® PRO - A Post-Market Data Collection Study N/A
Completed NCT03676101 - Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Phase 1
Not yet recruiting NCT06039111 - Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma Phase 2
Recruiting NCT06127836 - Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer N/A
Completed NCT04952961 - Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study N/A
Completed NCT01806350 - Pelvic Floor Muscle Training in Treating Urinary Incontinence in Gynecologic Cancer Survivors N/A
Completed NCT00019110 - Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer Phase 1
Recruiting NCT04141449 - A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation Phase 2