Sentinel Node Extended in Squamous Cell Vulvar Cancer

NCT04147780 | Completed

• 1 other identifier: 2019-04647
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 4

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.

Conditions

Vulva Cancer; Sentinel Lymph Node

Outcome Measures

Primary Outcomes (1)

• Detection rate and negative predictive value for sentinel node biopsy

  Calculated for each group separately. Per groin and per patient.

  2019-2021

Secondary Outcomes (2)

• Number of retrieved sentinel lymph nodes

  2019-2021

• Proportion of micrometastases and isolated tumor cells, diagnosed by ultra-staging in relation to routine-histopathological examination

  2019-2021

Study Arms (4)

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

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

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

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

Interventions

Sentinel node biopsy PROCEDURE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diana Zach: lead
• Sahlgrenska University Hospital: collaborator
• University Hospital, Linkoeping: collaborator
• Skane University Hospital: collaborator

Study Sites (4)

Karolinska University Hospital

Stockholm, Stockholm County, 17776, Sweden

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Linkopings University Hospital

Linköping, Sweden

Location

Skanes University Hospital Lund

Lund, Sweden

Location

Related Publications (2)

• 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.

  PMID: 37918956 DERIVED

• Zach 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.

  PMID: 31796533 DERIVED

MeSH Terms

Conditions

Vulvar Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Diana Zach, MD

  Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: December 14, 2019
• Primary Completion: December 14, 2022
• Study Completion: February 15, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

SE (4)