NCT00882791

Brief Summary

Basal cell carcinoma (BCC) is the most common skin cancer in the US and can cause significant adverse effects. Mohs micrographic surgery, the treatment of choice for higher risk BCC, allows for removal of lesions with preservation of healthy tissue. Although the BCC recurrence rate post Mohs surgery is estimated at 1-2%, recent data is lacking to validate this historical measurement. Our purpose is to determine the current recurrence rate of BCC after Mohs surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2008

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

May 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

April 16, 2009

Last Update Submit

November 30, 2021

Conditions

Basal Cell Carcinoma

Keywords

Skin CancerBasal CellMohs surgery

Outcome Measures

Primary Outcomes (1)

  • Recurrence of BCC

    either after 1 study visit (historical arm), or 3 years (prospective arm)

Secondary Outcomes (1)

  • Risk Factors for recurrence of BCC

    either after 1 study visit (historical arm), or 3 years (prospective arm)

Study Arms (2)

Historical Arm

266 cases of BCC treated with Mohs surgery approximately 2-5 years ago will be assessed for recurrence.

Prospective Arm

300 cases of BCC will be followed annually for 3 years after Mohs surgery to assess for recurrence.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be selected from Northwestern University - Department of Dermatology, Chicago, IL and from DuPage Medical Group Dermatology, Naperville, IL.

You may qualify if:

  • Subjects with BCC lesions on the head, neck, genitalia, hands, or feet
  • Subjects who have undergone Mohs micrographic surgery for BCC on or before December 31, 2006
  • Subjects with a medical record at the respective site
  • Subjects in a stable health condition, as determined by the principle investigator

You may not qualify if:

  • Subjects with basal cell nevus syndrome
  • Subjects with lesions only in areas other than the head, neck, genitalia,
  • hands and feet
  • Subjects who have not followed up through the Department of Dermatology
  • Subjects with recurrent BCC lesions diagnosed on or prior to the recorded date of Mohs surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

DuPage Medical Group Dermatology

Naperville, Illinois, 60563, United States

Location

Related Publications (3)

  • Mehrany K, Weenig RH, Pittelkow MR, Roenigk RK, Otley CC. High recurrence rates of Basal cell carcinoma after mohs surgery in patients with chronic lymphocytic leukemia. Arch Dermatol. 2004 Aug;140(8):985-8. doi: 10.1001/archderm.140.8.985.

    PMID: 15313816BACKGROUND

  • Robinson JK, Fisher SG. Recurrent basal cell carcinoma after incomplete resection. Arch Dermatol. 2000 Nov;136(11):1318-24. doi: 10.1001/archderm.136.11.1318.

    PMID: 11074691BACKGROUND

  • Dubin N, Kopf AW. Multivariate risk score for recurrence of cutaneous basal cell carcinomas. Arch Dermatol. 1983 May;119(5):373-7.

    PMID: 6847215BACKGROUND

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

  • Murad Alam, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation

Study Record Dates

First Submitted

April 16, 2009

First Posted

April 17, 2009

Study Start

May 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

December 2, 2021

Record last verified: 2021-11

Locations

US(2)