Basal Cell CarcinomaNCT00882791
Basal Cell Carcinoma Recurrence After Mohs Surgery
An observational study of Basal Cell Carcinoma, run by Northwestern University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- How many people
- 115 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be selected from Northwestern University - Department of Dermatology, Chicago, IL and from DuPage Medical Group Dermatology, Naperville, IL.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
DuPage Medical Group Dermatology
Naperville, Illinois, 60563
About this study
Official title: Basal Cell Carcinoma Recurrence
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.
Read the detailed description
Basal cell carcinoma (BCC) is the most common nonmelanoma skin cancer in the United States, affecting nearly one million of all Americans. While BCC is rarely mortal, it has significant associated physical, psychological, and monetary costs to patients such as disfigurement and sensory loss. Individuals who have been diagnosed with at least one BCC lesion are likely to be diagnosed with more in the future. Treatment of these lesions and recurrent physician appointments can be a great inconvenience to patients, resulting in expenses to patients and loss of work and family time.
The Mohs surgery technique is associated with a low recurrence rate for BCC and is preferred for higher risk tumors and for tumors in cosmetically sensitive sites on the head and neck. While recurrence rates of BCC post Mohs are 1-2% for primary basal cells, recent data is not available to validate this historical assessment. Currently, comprehensive rates of recurrence are not available because a national registry of recurrence rates for BCC and squamous cell carcinoma (SCC) does not exist.
The purpose of this study is to both historically and prospectively assess current basal cell carcinoma recurrence rates in patients undergoing Mohs micrographic surgery.
- Conditions
- Basal Cell Carcinoma
- Keywords
- Skin Cancer, Basal Cell, Mohs surgery
- Medical subject headings
- Carcinoma, Basal Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of BCC
Measured: either after 1 study visit (historical arm), or 3 years (prospective arm)
Secondary outcomes (1)
Risk Factors for recurrence of BCC
Measured: either after 1 study visit (historical arm), or 3 years (prospective arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882791
- Sponsor's protocol ID
- STU2538
- Status last verified
- Nov 2021
- First submitted
- 16 Apr 2009
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15313816Robinson 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.
PubMed 11074691Dubin N, Kopf AW. Multivariate risk score for recurrence of cutaneous basal cell carcinomas. Arch Dermatol. 1983 May;119(5):373-7.
PubMed 6847215
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basal Cell Carcinoma Recurrence
- ClinicalTrials.gov ID
- NCT00882791
- Acronym / sponsor ID
- STU2538
- Conditions
- Basal Cell Carcinoma
- Keywords
- Skin Cancer, Basal Cell, Mohs surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 17 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Basal cell carcinoma (BCC) is the most common nonmelanoma skin cancer in the United States, affecting nearly one million of all Americans. While BCC is rarely mortal, it has significant associated physical, psychological, and monetary costs to patients such as disfigurement and sensory loss. Individuals who have been diagnosed with at least one BCC lesion are likely to be diagnosed with more in the future. Treatment of these lesions and recurrent physician appointments can be a great inconvenience to patients, resulting in expenses to patients and loss of work and family time.
The Mohs surgery technique is associated with a low recurrence rate for BCC and is preferred for higher risk tumors and for tumors in cosmetically sensitive sites on the head and neck. While recurrence rates of BCC post Mohs are 1-2% for primary basal cells, recent data is not available to validate this historical assessment. Currently, comprehensive rates of recurrence are not available because a national registry of recurrence rates for BCC and squamous cell carcinoma (SCC) does not exist.
The purpose of this study is to both historically and prospectively assess current basal cell carcinoma recurrence rates in patients undergoing Mohs micrographic surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from Northwestern University - Department of Dermatology, Chicago, IL and from DuPage Medical Group Dermatology, Naperville, IL.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence of BCC
Time frame: either after 1 study visit (historical arm), or 3 years (prospective arm)
1 secondary outcome
Risk Factors for recurrence of BCC
Time frame: either after 1 study visit (historical arm), or 3 years (prospective arm)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Background: PubMed 15313816Mehrany 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.
- Background: PubMed 11074691Robinson 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.
- Background: PubMed 6847215Dubin N, Kopf AW. Multivariate risk score for recurrence of cutaneous basal cell carcinomas. Arch Dermatol. 1983 May;119(5):373-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murad Alam, MD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of BCC (time frame: either after 1 study visit (historical arm), or 3 years (prospective arm)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00882791, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.