Vulva CancerSNEXNCT04147780
Sentinel Node Extended in Squamous Cell Vulvar Cancer
An observational study of Vulva Cancer and Sentinel Lymph Node, run by Diana Zach at 4 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulva Cancer, Sentinel Lymph Node
- What is being tested?
- Sentinel node biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 4 sitesSweden
- Study dates
- 14 Dec 2019to 15 Feb 2023
- Phase
- Observational
- 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
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
Who may be able to join
- Patients with squamous cell vulvar cancer and
- primary tumors ≥ 4cm
- multifocal primary tumors
- local recurrence, earlier no treatment of the groins or only sentinel node biopsy
- local recurrence, earlier treatment of the groins with radiotherapy / inguinofemoral lymphadenectomy
- ≥ 18 years of age
- Considered clinically appropriate for surgery
- Informed consent
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Sahlgrenska University Hospital
Gothenburg
Linkopings University Hospital
Linköping
Skanes University Hospital Lund
Lund
Karolinska University Hospital
Stockholm, Stockholm County, 17776
About this study
Official title: Can the Investigators Extend the Indication for Sentinel Node Biopsy in Vulvar Cancer? A Nationwide Feasibility Study From Sweden
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.
Read the 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:
- primary tumors ≥4cm
- primary multifocal tumors
- local recurrence, earlier no treatment of the groins or only sentinel node biopsy
- 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.
- Conditions
- Vulva Cancer, Sentinel Lymph Node
- Being tested
- Sentinel node 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.
Sentinel node biopsyProcedure or surgery
Sentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy.
| Study group | Role | What they receive |
|---|---|---|
| Primary vulvar cancer, tumor ≥ 4cm | Patients with primary squamous cell vulvar cancer, unifocal tumor ≥ 4cm:
Sentinel node biopsy additional to radical inguinofemoral lymphadenectomy Receives: Procedure: Sentinel node biopsy | |
| Primary vulvar cancer, multifocal tumor | Patients with primary squamous cell vulvar cancer, multifocal tumor:
Sentinel node biopsy additional to radical inguinofemoral lymphadenectomy Receives: Procedure: Sentinel node biopsy | |
| 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 Receives: Procedure: Sentinel node biopsy | |
| 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 Receives: Procedure: Sentinel node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate and negative predictive value for sentinel node biopsy
Calculated for each group separately. Per groin and per patient.
Measured: 2019-2021
Secondary outcomes (2)
Number of retrieved sentinel lymph nodes
Per groin
Measured: 2019-2021
Proportion of micrometastases and isolated tumor cells, diagnosed by ultra-staging in relation to routine-histopathological examination
Per groin and per patient
Measured: 2019-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start14 Dec 2019
- Primary completion14 Dec 2022
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vulva 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diana Zach
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, University Hospital, Linkoeping, Skane University Hospital
- Responsible party
- Sponsor-investigator, Diana Zach, Karolinska University Hospital
- Investigators
- Diana Zach, MD, Principal investigator, Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147780
- Sponsor's protocol ID
- 2019-04647
- Other IDs
- 2019
- Acronym
- SNEX
- Status last verified
- Oct 2023
- First submitted
- 30 Oct 2019
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be available.
Publications
Zach D, Stenstrom Bohlin K, Kannisto P, Moberg L, Kjolhede P. Time to extend the indication for sentinel node biopsy in vulvar cancer? Results from a prospective nationwide Swedish study. Int J Gynecol Cancer. 2023 Dec 4;33(12):1845-1852. doi: 10.1136/ijgc-2023-004790.
PubMed 37918956Zach D, Kannisto P, Stenstrom Bohlin K, Moberg L, Kjolhede P. Can we extend the indication for sentinel node biopsy in vulvar cancer? A nationwide feasibility study from Sweden. Int J Gynecol Cancer. 2020 Mar;30(3):402-405. doi: 10.1136/ijgc-2019-000938. Epub 2019 Dec 2.
PubMed 31796533
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Investigators Extend the Indication for Sentinel Node Biopsy in Vulvar Cancer? A Nationwide Feasibility Study From Sweden
- ClinicalTrials.gov ID
- NCT04147780
- Acronym / sponsor ID
- SNEX / 2019-04647
- Conditions
- Vulva Cancer, Sentinel Lymph Node
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Diana ZachUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, University Hospital, Linkoeping, Skane University Hospital
- Study start
- 14 Dec 2019 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 1 Nov 2019 (actual)
- 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.
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.
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:
- primary tumors ≥4cm
- primary multifocal tumors
- local recurrence, earlier no treatment of the groins or only sentinel node biopsy
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Primary vulvar cancer, tumor ≥ 4cm | – | Procedure: Sentinel node biopsyPatients with primary squamous cell vulvar cancer, unifocal tumor ≥ 4cm: Sentinel node biopsy additional to radical inguinofemoral lymphadenectomy |
| Primary vulvar cancer, multifocal tumor | – | Procedure: Sentinel node biopsyPatients with primary squamous cell vulvar cancer, multifocal tumor: Sentinel node biopsy additional to radical inguinofemoral lymphadenectomy |
| Local recurrence after vulvar cancer, no earlier treatment | – | Procedure: Sentinel node biopsyPatients 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 |
| Local recurrence after vulvar cancer, earlier treatment | – | Procedure: Sentinel node biopsyPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- Patients with squamous cell vulvar cancer and
- ≥ 18 years of age
- Considered clinically appropriate for surgery
- Informed consent
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Sentinel node biopsySentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy. | Procedure or surgery | Local recurrence after vulvar cancer, earlier treatment, Local recurrence after vulvar cancer, no earlier treatment, Primary vulvar cancer, multifocal tumor, Primary vulvar cancer, tumor ≥ 4cm |
Primary outcome
Detection rate and negative predictive value for sentinel node biopsy
Time frame: 2019-2021
Calculated for each group separately. Per groin and per patient.
2 secondary outcomes
Number of retrieved sentinel lymph nodes
Time frame: 2019-2021
Proportion of micrometastases and isolated tumor cells, diagnosed by ultra-staging in relation to routine-histopathological examination
Time frame: 2019-2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Derived from this study: PubMed 37918956Zach D, Stenstrom Bohlin K, Kannisto P, Moberg L, Kjolhede P. Time to extend the indication for sentinel node biopsy in vulvar cancer? Results from a prospective nationwide Swedish study. Int J Gynecol Cancer. 2023 Dec 4;33(12):1845-1852. doi: 10.1136/ijgc-2023-004790.
- Derived from this study: PubMed 31796533Zach D, Kannisto P, Stenstrom Bohlin K, Moberg L, Kjolhede P. Can we extend the indication for sentinel node biopsy in vulvar cancer? A nationwide feasibility study from Sweden. Int J Gynecol Cancer. 2020 Mar;30(3):402-405. doi: 10.1136/ijgc-2019-000938. Epub 2019 Dec 2.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be available.
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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.
Diana Zach, MD principal investigator
Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulva Cancer and Sentinel Lymph Node, run by Diana Zach at 4 sites in Sweden.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate and negative predictive value for sentinel node biopsy (time frame: 2019-2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04147780, which also lists 2 linked publications.
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 1 Nov 2023.