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Sentinel Node Extended in Squamous Cell Vulvar Cancer (SNEX)

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ClinicalTrials.gov Identifier: NCT04147780
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : August 19, 2022
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
University Hospital, Linkoeping
Skane University Hospital
Information provided by (Responsible Party):
Diana Zach, Karolinska University Hospital

Study Description
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Brief Summary:
The aim of this study is to investigate the feasibility of sentinel node biopsy in patients with squamous cell vulvar cancer, currently not regarded suitable for the sentinel node technique, i.e. patients with tumors ≥4cm, multifocal tumors or locally recurrent disease. A positive result of this pilot study might constitute the basis for a future full-scale multinational trial.

Condition or disease Intervention/treatment
Vulva Cancer Sentinel Lymph Node Procedure: Sentinel node biopsy

Detailed Description:

PRIMARY OBJECTIVES:

This study is primarily a pilot and feasibility trial, aiming to evaluate if sentinel node biopsy has a satisfactory detection rate and negative predictive value in certain groups of vulvar cancer patients.

OUTLINE:

The study is planned as a prospective, multi-center cohort study in Sweden. Since 2017, the treatment of vulvar cancer patients has been accredited to four tertiary referral university hospitals in Sweden; the Sahlgrenska University hospital in Gothenburg, the Linköping University hospital, the Skåne University hospital in Lund and the Karolinska University hospital in Stockholm.

Eligible patients will undergo a sentinel node biopsy additionally to their radical inguinofemoral lymphadenectomy and detection rate and negative predictive value for the sentinel procedure will be calculated. The study will consist of four patient groups: Patients with squamous cell vulvar cancer and:

  1. primary tumors ≥4cm
  2. primary multifocal tumors
  3. local recurrence, earlier no treatment of the groins or only sentinel node biopsy
  4. local recurrence, earlier treatment of the groins with radiotherapy / inguinofemoral lymphadenectomy

It is estimated to include 20-30 patients in each study group during a time frame of about 24 months.

RESULTS:

Results are to be expected in the end of 2021.

Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can the Investigators Extend the Indication for Sentinel Node Biopsy in Vulvar Cancer? A Nationwide Feasibility Study From Sweden
Actual Study Start Date : December 14, 2019
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : February 15, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Primary vulvar cancer, tumor ≥ 4cm

Patients with primary squamous cell vulvar cancer, unifocal tumor ≥ 4cm:

Sentinel node biopsy additional to radical inguinofemoral lymphadenectomy

 Procedure: Sentinel node biopsy
Sentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy.
Primary vulvar cancer, multifocal tumor

Patients with primary squamous cell vulvar cancer, multifocal tumor:

Sentinel node biopsy additional to radical inguinofemoral lymphadenectomy

 Procedure: Sentinel node biopsy
Sentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy.
Local recurrence after vulvar cancer, no earlier treatment

Patients with a local recurrence of a primary squamous cell vulvar cancer, earlier without treatment of the groins or solely sentinel node biopsy:

Sentinel node biopsy additional to radical inguinofemoral lymphadenectomy

 Procedure: Sentinel node biopsy
Sentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy.
Local recurrence after vulvar cancer, earlier treatment

Patients with a local recurrence of a primary squamous cell vulvar cancer, earlier treatment of the groins by lymphadenectomy and / or (chemo-)radiation:

Sentinel node biopsy if detectable, otherwise no groin treatment

 Procedure: Sentinel node biopsy
Sentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy.


Outcome Measures
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Primary Outcome Measures :
  1. Detection rate and negative predictive value for sentinel node biopsy [ Time Frame: 2019-2021 ]
    Calculated for each group separately. Per groin and per patient.


Secondary Outcome Measures :
  1. Number of retrieved sentinel lymph nodes [ Time Frame: 2019-2021 ]
    Per groin

  2. Proportion of micrometastases and isolated tumor cells, diagnosed by ultra-staging in relation to routine-histopathological examination [ Time Frame: 2019-2021 ]
    Per groin and per patient


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with primary squamous vulvar cancer with tumors ≥ 4cm or multifocal tumors, and all patients with a local recurrence after primary squamous vulvar cancer in Sweden, diagnosed during the recruitment period
Criteria

Inclusion Criteria:

  • Patients with squamous cell vulvar cancer and

    1. primary tumors ≥ 4cm
    2. multifocal primary tumors
    3. local recurrence, earlier no treatment of the groins or only sentinel node biopsy
    4. local recurrence, earlier treatment of the groins with radiotherapy / inguinofemoral lymphadenectomy
  • ≥ 18 years of age
  • Considered clinically appropriate for surgery
  • Informed consent

Exclusion Criteria:

  • Eastern Cooperative Oncology Group performance status > 2
  • Disability to read or write in Swedish
  • Dementia / severe psychiatric illness leading to disability to understand the study / study information
  • Signs of inguinal lymph node or distant metastases
  • Ongoing pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04147780


Contacts
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Contact: Diana Zach, MD +46851775922 diana.zach@sll.se

Locations
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Sweden
Karolinska University Hospital Recruiting
Stockholm, Stockholms Lan, Sweden, 17776
Contact: Diana Zach, MD    +46851775922    diana.zach@sll.se   
Sahlgrenska University Hospital Not yet recruiting
Gothenburg, Sweden
Contact: Katja Stenstrom Bohlin, PhD         
Linkopings University Hospital Not yet recruiting
Linkoping, Sweden
Contact: Preben Kjoelhede, PhD         
Skanes University Hospital Lund Not yet recruiting
Lund, Sweden
Contact: Louise Moberg, PhD         
Sponsors and Collaborators
Diana Zach
Sahlgrenska University Hospital, Sweden
University Hospital, Linkoeping
Skane University Hospital
Investigators
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Principal Investigator: Diana Zach, MD Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Diana Zach, Principal Investigator, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT04147780    
Other Study ID Numbers: 2019-04647
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: August 19, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 6 months after publication
Access Criteria: Data excess requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Vulvar Diseases