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Identifying Skin Biopsy Sites

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT01632644
First received: June 27, 2012
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

The primary objective of this study is to investigate the patient experience during skin biopsy.


Condition Intervention
Identification of Skin Cancer Biopsy Sites
 Other: Survey/Interview

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Pilot Study of Skin Biopsy Sites: A Consensus Approach Based on Patient and Physician Interviews

Resource links provided by NLM:

MedlinePlus related topics: Cancer Skin Cancer
U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Review of Physician and Patient Experience [ Time Frame: Last four weeks of study ] [ Designated as safety issue: No ]

    Subjects will answer a combination of:

    1. Open-ended questions and
    2. Questions asking for subject to rank possible responses


Secondary Outcome Measures:
  • Physician's Experience with Skin Biopsy Sites [ Time Frame: First four weeks of study ] [ Designated as safety issue: No ]

    Physicians will answer a combination of:

    1. Open-ended questions, and
    2. Questions asking for subject to rank possible responses

  • Patient's Experience with Skin Biopsy Sites [ Time Frame: First four weeks of study ] [ Designated as safety issue: No ]

    Patients will answer a combination of:

    1. Open-ended questions and
    2. Questions asking for subject to rank possible responses


Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Physicians
Physicians performing skin biopsies
 Other: Survey/Interview
Each group will be surveyed and interviewed.
Patients
Patients who have had skin biopsies
 Other: Survey/Interview
Each group will be surveyed and interviewed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Physicians will be recruited by email obtained through directories.

Patients will be those who have had biopsies at the Northwestern University Department of Dermatology.

Criteria

Inclusion Criteria:

  • Age 18 and Over
  • The subjects are in good health.
  • The subjects have the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
  • Patients who have had one or multiple skin biopsies OR board-certified dermatologists.

Exclusion Criteria:

  • Under 18 years of age.
  • Subjects who are unable to understand the protocol or give informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632644

Locations
United States, Illinois
Northwestern University Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

No publications provided

Responsible Party: Murad Alam, Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT01632644     History of Changes
Other Study ID Numbers: STU66384
Study First Received: June 27, 2012
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013