Vulvar CancerMorpho-NodeNCT02988765
Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma
A study testing Groin ultrasound +/- fine needle aspiration in people with Vulvar Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Cancer
- What is being tested?
- Groin ultrasound +/- fine needle aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Invasive vulvar cancer (all infiltrating histotypes)
- Age >18 years
Who cannot join
- patient unable to follow the study procedures
- patient with major depressive disorder
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Division of Gynecologic Oncology/Fondazione Policlinico Gemelli
Rome, Rome, 00168
Giorgia Garganese, MD, 00390630158545, ggarganese@gmail.com
Simona M Fragomeni, MD, 00390630158545, simona.fragomeni@gmail.com
About this study
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.
Read the detailed 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.
- Conditions
- Vulvar Cancer
- Being tested
- Groin ultrasound +/- fine needle aspiration
- Keywords
- vulvar cancer, inguinal lymph node, lymph node status, cytology, core biopsy
- Medical subject headings
- Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Groin ultrasound +/- fine needle aspirationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Invasive vulvar cancer (IVC) | Experimental | * Vulvar carcinoma (stromal infiltration > 1 mm)
* Histotypes different from squamous cells carcinomas are included Receives: Procedure: Groin ultrasound +/- fine needle aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of ultrasound morphometry (USM) in the prediction of groin lymph node status
Measured: 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
Measured: within the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Giovanni Scambia, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988765
- Sponsor's protocol ID
- Morpho-Node
- Acronym
- Morpho-Node
- Status last verified
- Dec 2016
- First submitted
- 2 Dec 2016
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma
- ClinicalTrials.gov ID
- NCT02988765
- Acronym / sponsor ID
- Morpho-Node / Morpho-Node
- Conditions
- Vulvar Cancer
- Keywords
- vulvar cancer, inguinal lymph node, lymph node status, cytology, core biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invasive vulvar cancer (IVC) | Experimental | Procedure: Groin ultrasound +/- fine needle aspiration* Vulvar carcinoma (stromal infiltration > 1 mm) * Histotypes different from squamous cells carcinomas are included |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Invasive vulvar cancer (all infiltrating histotypes)
- Age >18 years
Key exclusion criteria (2 listed)
- patient unable to follow the study procedures
- patient with major depressive disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Groin ultrasound +/- fine needle aspirationPreoperative 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 | Procedure or surgery | Invasive vulvar cancer (IVC) |
Primary outcome
Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of ultrasound morphometry (USM) in the prediction of groin lymph node status
Time frame: 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
Time frame: within the first 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Division of Gynecologic Oncology/Fondazione Policlinico Gemelli
Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Groin ultrasound +/- fine needle aspiration in people with Vulvar Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of ultrasound morphometry (USM) in the prediction of groin lymph node status (time frame: within the first 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2016.