Sentinel Lymph Node Biopsy in Porocarcinoma

NCT03647631 | Completed

• 1 other identifier: Chirurgia1
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Eccrine porocarcinoma (EPC) is a slow-growing carcinoma arising from the eccrine sweat glands. Based on its clinical presentation it can be confused with malignant and benign skin lesions, both. Histological examination is essential to formulate a correct diagnosis. Surgical excision with clear margins is the standard therapeutic approach while the role of sentinel lymph node biopsy (SNLB) remains controversial. The Authors report two cases of EPC of the lower limbs occurred in two women. Patients were treated by wide surgical excision of the lesion and SNLB.

Conditions

Porocarcinoma; Sentinel Lymph Node

Outcome Measures

Primary Outcomes (1)

• Role of SNLB in porocarcinoma in two patients evaluating the percentage of positive lymph nodes removed.

  The investigators evaluated the role of SNLB in patients affected to moderate and high risk porocarcinoma.

  Patients were treated by wide surgical excision of the lesion and SNLB. 6 months follow-up was the time frame of the study.

Study Arms (2)

Patients affected to porocarcinoma

Procedure: sentinel lymph node biopsy

patients affected to porocarcinoma in our centre

Procedure: sentinel lymph node biopsy

Interventions

sentinel lymph node biopsy PROCEDURE

Authors discuss a possible usefulness of SNLB for staging and diagnosis in porocarcinoma.

Patients affected to porocarcinoma; patients affected to porocarcinoma in our centre

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

two cases of EPC in which the sentinel lymph node biopsy (SLNB) was performed.

You may qualify if:

• Thickness greater than or equal to 5mm
• mitoses per 10 high-power field greater than or equal to 7
• Immunohistochemical (IHC) analysis positive for :carcinoembryonic antigen (CEA), cytokeratin (CK) 5,7 and epithelial membrane antigen (EMA).
• Informed consent obtained for the SNLB procedure.

Sponsors & Collaborators

• Ospedale Policlinico San Martino: lead

Study Sites (1)

Denise Palombo

Genoa, 16036, Italy

Location

MeSH Terms

Conditions

Eccrine Porocarcinoma

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

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 Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 27, 2018
• Study Start: July 17, 2018
• Primary Completion: August 1, 2018
• Study Completion: August 17, 2018
• Last Updated: August 27, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)