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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04147780
Other study ID # 2019-04647
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 14, 2019
Est. completion date February 15, 2023

Study information

Verified date October 2023
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. A positive result of this pilot study might constitute the basis for a future full-scale multinational trial.


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date February 15, 2023
Est. primary completion date December 14, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg
Sweden Linkopings University Hospital Linkoping
Sweden Skanes University Hospital Lund Lund
Sweden Karolinska University Hospital Stockholm Stockholms Lan

Sponsors (4)

Lead Sponsor Collaborator
Diana Zach Sahlgrenska University Hospital, Sweden, Skane University Hospital, University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Detection rate and negative predictive value for sentinel node biopsy Calculated for each group separately. Per groin and per patient. 2019-2021
Secondary Number of retrieved sentinel lymph nodes Per groin 2019-2021
Secondary Proportion of micrometastases and isolated tumor cells, diagnosed by ultra-staging in relation to routine-histopathological examination Per groin and per patient 2019-2021
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