Basal Cell CarcinomaNCT05473507
A Study of Observation and Follow-up in People With Basal Cell Carcinoma
An observational study of Basal Cell Carcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to find out more about how Basal Cell Carcimonas/BCCs grow and to learn more effective ways to monitor and treat these common cancers. This study will not provide any type of treatment for the participants' cancer; it is a 3-year observational study to monitor participants' cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Digital Dermoscopy, Reflectance confocal microscopy (RCM) and Optical coherence tomography (OCT)
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2022to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 with at least 1 BCC eligible for the study will be recruited from the Memorial Sloan Kettering Dermatology sites at the Manhattan and Hauppauge clinics. Only 1 of the participant's BCCs will be selected for inclusion in the study. All patients 18 years of age or older who have been diagnosed with BCC will be eligible for the study.
Who may be able to join
- Patients 18 years of age or older
- Diagnosed with at least 1 BCC based on clinical, dermoscopy, RCM and OCT
- Patients with BCCs that have a diameter smaller or equal to 1.5cm, allowing for 0.5cm growth before reaching the cutoff for stage 2 BCC, which would require removal of the BCC.
- Patients with BCCs that have a depth smaller or equal to 0.6mm, to allow for tumor growth of 0.2mm before reaching the depth limitation of OCT imaging (0.8mm)
- Treatment naiive lesions
- Ability to sign informed consent
Who cannot join
- Immunosuppressed patients, such as those with a primary immunodeficiency caused by a genetic abnormality and a secondary immunodeficiency caused by AIDS, cancer, chemotherapy and other immunomodulating drugs, solid organ transplant recipitents, CLL, aspelenia, and pregnancy).
- Patients with cancer genetic syndromes that increase risk of BCC (such as basal cell nevus syndrome, xeroderma pigmentosum, epidermolysis bulosa, oculocutaneous albinism, bazex-dupre-christol syndrome, rothmund-thomson syndrome, and epidermodysplasia verruciformis).
- Patients with BCCs that are clinically suspected as high risk histopathologic subtypes, i.e. indented or sclerotic lesions that are suspected as morpheaform or infiltrative BCCs.
- Patients with BCCs that have a diameter larger than 1.5cm\
- Patients with BCCs that have a depth greater than 0.6mm
- Patients with BCCs in high risk locations, i.e. "H" area of the face. (is located in the mid-face at the site of the embryologic fusion plates and is generally believed to be associated with more aggressive skin cancers).
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- Patients with BCCs on locations that may compromise an organ function should the tumor enlarge (for example, eyelid).
- Tumor located on a site that precludes attachment of the RCM device or inability to tolerate imaging procedure (i.e. remain relatively still for multiple short durations of 3- 4 minutes over a total time of 20-30 minutes)
- Lesions that previously received therapeutic intervention
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
About this study
Official title: Basal Cell Carcinoma Follow Up Study. A Prospective Study
The purpose of this study is to find out more about how Basal Cell Carcimonas/BCCs grow and to learn more effective ways to monitor and treat these common cancers. This study will not provide any type of treatment for the participants' cancer; it is a 3-year observational study to monitor participants' cancer.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Digital Dermoscopy, Reflectance confocal microscopy (RCM), Optical coherence tomography (OCT), Dermtech tape-stripping, Total Skin Examinations
- Keywords
- Basal Cell Carcinoma, Memorial Sloan Kettering Cancer Center, 21-007
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital DermoscopyDiagnostic test
Digital Dermoscopy will be performed every 3 months.
Reflectance confocal microscopy (RCM)Diagnostic test
Reflectance confocal microscopy (RCM) will be performed every 3 months.
Optical coherence tomography (OCT)Diagnostic test
Optical coherence tomography (OCT) will be performed every 3 months.
Dermtech tape-strippingDiagnostic test
Dermtech tape-stripping for genetic analysiswill be performed every 6 months.
Total Skin ExaminationsDiagnostic test
Total Skin Examinations will be performed every 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Participant with Basal Cell Carcinoma/BCC | Participants have been diagnosed with at least 1 Basal Cell Carcinoma/BCC based on clinical, dermoscopy, RCM (reflectance confocal microscopy) and OCT (optical coherence tomography) Receives: Diagnostic Test: Digital Dermoscopy; Diagnostic Test: Reflectance confocal microscopy (RCM); Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Dermtech tape-stripping; Diagnostic Test: Total Skin Examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Basal Cell Carcinoma growth from Baseline
To adequately measure the growth dynamics of tumors, several imaging modalities will be employed. Longest dimension (millimeters) of the lesion from clinical imaging will be the primary measurement of horizontal extent of the lesion. Maximum lesion depth (millimeters) from OCT imaging will be the primary measured of vertical extension.
Measured: 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To evaluate the feasibility of active follow-up of BCC as a way of managing BCC.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start27 Jul 2022
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashfaq Marghoob, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473507
- Sponsor's protocol ID
- 21-007
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2022
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basal Cell Carcinoma Follow Up Study. A Prospective Study
- ClinicalTrials.gov ID
- NCT05473507
- Acronym / sponsor ID
- 21-007
- Conditions
- Basal Cell Carcinoma
- Keywords
- Basal Cell Carcinoma, Memorial Sloan Kettering Cancer Center, 21-007
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 26 Jul 2022 (actual)
- 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.
The purpose of this study is to find out more about how Basal Cell Carcimonas/BCCs grow and to learn more effective ways to monitor and treat these common cancers. This study will not provide any type of treatment for the participants' cancer; it is a 3-year observational study to monitor participants' cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant with Basal Cell Carcinoma/BCC | – | Diagnostic Test: Digital Dermoscopy, Diagnostic Test: Reflectance confocal microscopy (RCM), Diagnostic Test: Optical coherence tomography (OCT), Diagnostic Test: Dermtech tape-stripping, Diagnostic Test: Total Skin ExaminationsParticipants have been diagnosed with at least 1 Basal Cell Carcinoma/BCC based on clinical, dermoscopy, RCM (reflectance confocal microscopy) and OCT (optical coherence tomography) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with at least 1 BCC eligible for the study will be recruited from the Memorial Sloan Kettering Dermatology sites at the Manhattan and Hauppauge clinics. Only 1 of the participant's BCCs will be selected for inclusion in the study. All patients 18 years of age or older who have been diagnosed with BCC will be eligible for the study.
Key inclusion criteria (6 listed)
- Patients 18 years of age or older
- Diagnosed with at least 1 BCC based on clinical, dermoscopy, RCM and OCT
- Patients with BCCs that have a diameter smaller or equal to 1.5cm, allowing for 0.5cm growth before reaching the cutoff for stage 2 BCC, which would require removal of the BCC.
- Patients with BCCs that have a depth smaller or equal to 0.6mm, to allow for tumor growth of 0.2mm before reaching the depth limitation of OCT imaging (0.8mm)
- Treatment naiive lesions
Key exclusion criteria (10 listed)
- Immunosuppressed patients, such as those with a primary immunodeficiency caused by a genetic abnormality and a secondary immunodeficiency caused by AIDS, cancer, chemotherapy and other immunomodulating drugs, solid organ transplant recipitents, CLL, aspelenia, and pregnancy).
- Patients with cancer genetic syndromes that increase risk of BCC (such as basal cell nevus syndrome, xeroderma pigmentosum, epidermolysis bulosa, oculocutaneous albinism, bazex-dupre-christol syndrome, rothmund-thomson syndrome, and epidermodysplasia verruciformis).
- Patients with BCCs that are clinically suspected as high risk histopathologic subtypes, i.e. indented or sclerotic lesions that are suspected as morpheaform or infiltrative BCCs.
- Patients with BCCs that have a diameter larger than 1.5cm\
- Patients with BCCs that have a depth greater than 0.6mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital DermoscopyDigital Dermoscopy will be performed every 3 months. | Diagnostic test | Participant with Basal Cell Carcinoma/BCC |
| Reflectance confocal microscopy (RCM)Reflectance confocal microscopy (RCM) will be performed every 3 months. | Diagnostic test | Participant with Basal Cell Carcinoma/BCC |
| Optical coherence tomography (OCT)Optical coherence tomography (OCT) will be performed every 3 months. | Diagnostic test | Participant with Basal Cell Carcinoma/BCC |
| Dermtech tape-strippingDermtech tape-stripping for genetic analysiswill be performed every 6 months. | Diagnostic test | Participant with Basal Cell Carcinoma/BCC |
| Total Skin ExaminationsTotal Skin Examinations will be performed every 12 months. | Diagnostic test | Participant with Basal Cell Carcinoma/BCC |
Primary outcome
Change in Basal Cell Carcinoma growth from Baseline
Time frame: 3 years
To adequately measure the growth dynamics of tumors, several imaging modalities will be employed. Longest dimension (millimeters) of the lesion from clinical imaging will be the primary measurement of horizontal extent of the lesion. Maximum lesion depth (millimeters) from OCT imaging will be the primary measured of vertical extension.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 3 years
To evaluate the feasibility of active follow-up of BCC as a way of managing BCC.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Ashfaq Marghoob, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site 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 Memorial Sloan Kettering Cancer Center at 1 site 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 6 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Basal Cell Carcinoma growth from Baseline (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2026.