Biomarker Database Registry for Photodynamic Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/13/2019 |
| Start Date: | October 6, 2017 |
| End Date: | November 30, 2022 |
| Contact: | Jeff Negrey, MA |
| Email: | negreyj2@ccf.org |
| Phone: | 216-636-5504 |
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- taking doxycline, a photosensitizer
- using topical retinoids, since these can exacerbate the post-PDT erythema reaction
- pregnant
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