Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sentinel Lymph Node Biopsy in Porocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03647631
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ospedale Policlinico San Martino

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.


Condition or disease Intervention/treatment
Porocarcinoma Sentinel Lymph Node Procedure: sentinel lymph node biopsy

  Show Detailed Description

Layout table for study information
Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Sentinel Lymph Node Biopsy in Porocarcinoma: A Case Reports
Actual Study Start Date : July 17, 2018
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
Patients affected to porocarcinoma Procedure: sentinel lymph node biopsy
Authors discuss a possible usefulness of SNLB for staging and diagnosis in porocarcinoma.

patients affected to porocarcinoma in our centre Procedure: sentinel lymph node biopsy
Authors discuss a possible usefulness of SNLB for staging and diagnosis in porocarcinoma.




Primary Outcome Measures :
  1. Role of SNLB in porocarcinoma in two patients evaluating the percentage of positive lymph nodes removed. [ Time Frame: Patients were treated by wide surgical excision of the lesion and SNLB. 6 months follow-up was the time frame of the study. ]
    The investigators evaluated the role of SNLB in patients affected to moderate and high risk porocarcinoma.



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.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
two cases of EPC in which the sentinel lymph node biopsy (SLNB) was performed.
Criteria

patients affected to moderate and high risk porocarcinoma, in according to hystophatological findings, submitted to SNLB.

Inclusion criteria:

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

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): NCT03647631


Locations
Layout table for location information
Italy
Denise Palombo
Genoa, Italy, 16036
Sponsors and Collaborators
Ospedale Policlinico San Martino

Layout table for additonal information
Responsible Party: Ospedale Policlinico San Martino
ClinicalTrials.gov Identifier: NCT03647631     History of Changes
Other Study ID Numbers: Chirurgia1
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Eccrine Porocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms