NCT02576769

Brief Summary

Basal cell carcinoma (BCC) is the most frequent neoplasia worldwide. There are more than 30 histopathologic subtypes, however the nodular subtype is the most common. Pigmented varieties are common in darker skin types, therefore in our country. Previous studies have shown an increase number and size of melanocytes. Melanogenesis were increased at the expense of hyperfunctioning melanocytes as well. The aim of the study was to describe the characteristics of melanocytes in pigmented and non-pigmented variants of basal cell carcinoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 15, 2015

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

October 13, 2015

Last Update Submit

October 13, 2015

Conditions

Basal Cell Carcinoma

Keywords

Basal cell carcinomaPigmentationMelanocyteMelaninSkin cancer

Outcome Measures

Primary Outcomes (3)

  • Melanocyte number

    To quantify the number of melanocytes in basal cell carcinoma

    Up to 1 year

  • Melanocyte phenotype

    To quantify melanocyte maturation stages in basal cell carcinoma through markers

    Up to 1 year

  • Melanogenesis characteristics

    To quantify the expression of melanogenic markers in basal cell carcinoma

    Up to 1 year

Secondary Outcomes (4)

  • Melanin presence

    Up to 1 year

  • Vessels number (angiogenesis)

    Up to 1 year

  • Mast cells number

    Up to 1 year

  • Solar elastosis quantity

    Up to 1 year

Study Arms (1)

Basal cell carcinoma

Basal cell carcinoma

Other: No intervention

Interventions

No interventionOTHER
Basal cell carcinoma

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with histologic diagnosis of basal cell carcinoma

You may qualify if:

  • Mexican subjects
  • Age between 40 and 90 years
  • Both genders
  • Sign informed consent

You may not qualify if:

  • Sign informed consent withdrawal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Central Dr. Ignacio Morones Prieto

San Luis Potosí City, San Luis Potosí, 78210, Mexico

Location

Related Publications (3)

  • Lao LM, Kumakiri M, Kiyohara T, Kuwahara H, Ueda K. Sub-populations of melanocytes in pigmented basal cell carcinoma: a quantitative, ultrastructural investigation. J Cutan Pathol. 2001 Jan;28(1):34-43. doi: 10.1034/j.1600-0560.2001.280104.x.

    PMID: 11168750BACKGROUND

  • Sakuraba K, Hayashi N, Kawashima M, Imokawa G. Down-regulated PAR-2 is associated in part with interrupted melanosome transfer in pigmented basal cell epithelioma. Pigment Cell Res. 2004 Aug;17(4):371-8. doi: 10.1111/j.1600-0749.2004.00156.x.

    PMID: 15250939BACKGROUND

  • Frey LM, Houben R, Brocker EB. Pigmentation, Melanocyte Colonization, and p53 Status in Basal Cell Carcinoma. J Skin Cancer. 2011;2011:349726. doi: 10.1155/2011/349726. Epub 2010 Sep 29.

    PMID: 21152129BACKGROUND

MeSH Terms

Conditions

Carcinoma, Basal CellSkin Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Juan P Castanedo-Cazares, MD, MSc

    Hospital Central "Dr. Ignacio Morones Prieto"

    STUDY DIRECTOR

  • Bertha Torres-Alvarez, MD

    Hospital Central "Dr. Ignacio Morones Prieto"

    STUDY CHAIR

Central Study Contacts

Juan P Castanedo-Cazares, MD, MSc

CONTACT

4448342795castanju@yahoo.com

Bertha Bertha Torres-Alvarez, MD

CONTACT

4448342795torresmab@yahoo.com.mx

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 15, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

October 15, 2015

Record last verified: 2015-10

Locations

ME(1)