Actinic KeratosisNCT03319251
Biomarker Database Registry for Photodynamic Therapy
An observational study of Actinic Keratosis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this research is to obtain a blood sample from patients with actinic keratoses undergoing routine Photodynamic Therapy, in order to measure biomarkers that are relevant to VitD and 5FU metabolism and might be predictive of PDT outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2017to 31 Oct 2023
- How long will I take part?
- 6 Months
- 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: The desired population for this study is 100 patients who have at least 10 nonhypertrophic actinic keratosis lesions present on the face, scalp, forearms, chest, or legs and are scheduled to receive Photodynamic Therapy (PDT) at the Cleveland Clinic noninvasive cutaneous oncology clinic.
Who may be able to join
- Males or females, at least 18 years of age
- Patient has nonhypertrophic actinic keratosis, at least 10 AK lesions present on the face, scalp, forearms, chest, or legs at the time of PDT treatment
Who cannot join
- taking doxycline, a photosensitizer
- using topical retinoids, since these can exacerbate the post-PDT erythema reaction
- pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarkers of Clinical Responsiveness to Photodynamic Therapy
The purpose of this research is to obtain a blood sample from patients with actinic keratoses undergoing routine Photodynamic Therapy, in order to measure biomarkers that are relevant to VitD and 5FU metabolism and might be predictive of PDT outcome. The biomarkers to be examined include serum VitD levels at the time of PDT, and the presence/absence of gene alleles that correlate with expression of several proteins involved in VitD and 5FU metabolism. The presence of these biomarkers will be correlated to the improvement in AK lesion counts at the patient's routine follow-up visit 3 months after PDT treatment.
Read the detailed description
Patients who have been scheduled to receive PDT in our noninvasive cutaneous oncology clinics will be given written information prior to their visit, including a copy of the Informed Consent (IC) that describes the purpose of the study. If the patient indicates that he/she is interested, the physician or study nurse will review the IC with the patient on the day of PDT and answer all questions. After the patient signs the IC, the patient will have their blood drawn by a caregiver who has completed PTS Phlebotomy Training.
DNA samples will be stored in a locked minus 80 degree ultrafreezer, in Dr. Maytin's laboratory (room ND4-25A in the Lerner Research Institute). The samples will be maintained for up to 10 years.
Blood sample tubes and data sheets in the laboratory will be labeled with a code consisting of the first 5 digits of the patient's 8-digit MRN along with the date that the phlebotomy was performed (i.e. the date of the blood draw). This should ensure anonymity of the data while preventing mistakes when linking the laboratory results to the correct patient. Study personnel with password-protected access to the database registry will use the code to unequivocally identify the subject's file within the Oracle database and thereby enter the subject's laboratory results into the proper data field.
The Informed Consent document informs the subject that he/she can withdraw permission for use of their samples at any time, and explains how to do this by contacting the Principal Investigator (PI) in writing.
Information will not be disclosed to third party outside of Cleveland Clinic for research purposes.
- Conditions
- Actinic Keratosis
- Medical subject headings
- Keratosis, Actinic
What is being measured
The primary outcome is the main question the study is designed to answer.
Actinic Keratosis (AK) clearance
Change in AK lesions present at 3 months post-PDT treatment
Measured: at 3 months post-treatment
Vitamin D levels
Vitamin D level (25-hydroxy-cholecalciferol) measured in serum
Measured: At baseline, which is the day of PDT treatment
Secondary outcomes (2)
Allele polymorphisms in the gene of the Vitamin D receptor (VDR)
Identify the allele combination present at VDR locus
Measured: At baseline, which is the day of PDT treatment
Allele polymorphisms in the gene promoter of thymidylate synthase (TS) enzyme
Identify the allele combination present at TS locus
Measured: At baseline, which is the day of PDT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start6 Oct 2017
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Maytin, MD, PhD, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319251
- Sponsor's protocol ID
- 16-1615
- Status last verified
- Nov 2023
- First submitted
- 12 Oct 2017
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data, needs HIPPA clearance and specific IRB approval, we did not plan on original data being shared
Publications
Heusinkveld LE, Bullock TA, Negrey J, Warren CB, Maytin EV. Sandpaper curettage: A simple method to improve PDT outcomes for actinic keratosis. Photodiagnosis Photodyn Ther. 2022 Dec;40:103050. doi: 10.1016/j.pdpdt.2022.103050. Epub 2022 Aug 3.
PubMed 35932960Bullock TA, Negrey J, Hu B, Warren CB, Hasan T, Maytin EV. Significant improvement of facial actinic keratoses after blue light photodynamic therapy with oral vitamin D pretreatment: An interventional cohort-controlled trial. J Am Acad Dermatol. 2022 Jul;87(1):80-86. doi: 10.1016/j.jaad.2022.02.067. Epub 2022 Mar 18.
PubMed 35314199
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Clinical Responsiveness to Photodynamic Therapy
- ClinicalTrials.gov ID
- NCT03319251
- Acronym / sponsor ID
- 16-1615
- Conditions
- Actinic Keratosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 24 Oct 2017 (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 research is to obtain a blood sample from patients with actinic keratoses undergoing routine Photodynamic Therapy, in order to measure biomarkers that are relevant to VitD and 5FU metabolism and might be predictive of PDT outcome. The biomarkers to be examined include serum VitD levels at the time of PDT, and the presence/absence of gene alleles that correlate with expression of several proteins involved in VitD and 5FU metabolism. The presence of these biomarkers will be correlated to the improvement in AK lesion counts at the patient's routine follow-up visit 3 months after PDT treatment.
Detailed description
Patients who have been scheduled to receive PDT in our noninvasive cutaneous oncology clinics will be given written information prior to their visit, including a copy of the Informed Consent (IC) that describes the purpose of the study. If the patient indicates that he/she is interested, the physician or study nurse will review the IC with the patient on the day of PDT and answer all questions. After the patient signs the IC, the patient will have their blood drawn by a caregiver who has completed PTS Phlebotomy Training.
DNA samples will be stored in a locked minus 80 degree ultrafreezer, in Dr. Maytin's laboratory (room ND4-25A in the Lerner Research Institute). The samples will be maintained for up to 10 years.
Blood sample tubes and data sheets in the laboratory will be labeled with a code consisting of the first 5 digits of the patient's 8-digit MRN along with the date that the phlebotomy was performed (i.e. the date of the blood draw). This should ensure anonymity of the data while preventing mistakes when linking the laboratory results to the correct patient. Study personnel with password-protected access to the database registry will use the code to unequivocally identify the subject's file within the Oracle database and thereby enter the subject's laboratory results into the proper data field.
The Informed Consent document informs the subject that he/she can withdraw permission for use of their samples at any time, and explains how to do this by contacting the Principal Investigator (PI) in writing.
Information will not be disclosed to third party outside of Cleveland Clinic for research purposes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The desired population for this study is 100 patients who have at least 10 nonhypertrophic actinic keratosis lesions present on the face, scalp, forearms, chest, or legs and are scheduled to receive Photodynamic Therapy (PDT) at the Cleveland Clinic noninvasive cutaneous oncology clinic.
Key inclusion criteria (2 listed)
- Males or females, at least 18 years of age
- Patient has nonhypertrophic actinic keratosis, at least 10 AK lesions present on the face, scalp, forearms, chest, or legs at the time of PDT treatment
Key exclusion criteria (3 listed)
- taking doxycline, a photosensitizer
- using topical retinoids, since these can exacerbate the post-PDT erythema reaction
- pregnant
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
Actinic Keratosis (AK) clearance
Time frame: at 3 months post-treatment
Change in AK lesions present at 3 months post-PDT treatment
Vitamin D levels
Time frame: At baseline, which is the day of PDT treatment
Vitamin D level (25-hydroxy-cholecalciferol) measured in serum
2 secondary outcomes
Allele polymorphisms in the gene of the Vitamin D receptor (VDR)
Time frame: At baseline, which is the day of PDT treatment
Allele polymorphisms in the gene promoter of thymidylate synthase (TS) enzyme
Time frame: At baseline, which is the day of PDT treatment
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 14 Nov 2023.
- Derived from this study: PubMed 35932960Heusinkveld LE, Bullock TA, Negrey J, Warren CB, Maytin EV. Sandpaper curettage: A simple method to improve PDT outcomes for actinic keratosis. Photodiagnosis Photodyn Ther. 2022 Dec;40:103050. doi: 10.1016/j.pdpdt.2022.103050. Epub 2022 Aug 3.
- Derived from this study: PubMed 35314199Bullock TA, Negrey J, Hu B, Warren CB, Hasan T, Maytin EV. Significant improvement of facial actinic keratoses after blue light photodynamic therapy with oral vitamin D pretreatment: An interventional cohort-controlled trial. J Am Acad Dermatol. 2022 Jul;87(1):80-86. doi: 10.1016/j.jaad.2022.02.067. Epub 2022 Mar 18.
- Individual participant dataSharing planned: No. No plan to share data, needs HIPPA clearance and specific IRB approval, we did not plan on original data being shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Actinic Keratosis, run by The Cleveland Clinic 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 2 inclusion and 3 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 14 Nov 2023. 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?
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?
Actinic Keratosis (AK) clearance (time frame: at 3 months post-treatment). 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?
On the ClinicalTrials.gov record for NCT03319251, which also lists 2 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 14 Nov 2023.