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Biomarker Database Registry for Photodynamic Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03319251
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
Edward Maytin, MD, PhD, The Cleveland Clinic

Brief 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. 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.

Condition or disease
Actinic Keratosis

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Biomarkers of Clinical Responsiveness to Photodynamic Therapy
Actual Study Start Date : October 6, 2017
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D




Primary Outcome Measures :
  1. Actinic Keratosis (AK) clearance [ Time Frame: at 3 months post-treatment ]
    Change in AK lesions present at 3 months post-PDT treatment

  2. Vitamin D levels [ Time Frame: At baseline, which is the day of PDT treatment ]
    Vitamin D level (25-hydroxy-cholecalciferol) measured in serum


Secondary Outcome Measures :
  1. Allele polymorphisms in the gene of the Vitamin D receptor (VDR) [ Time Frame: At baseline, which is the day of PDT treatment ]
    Identify the allele combination present at VDR locus

  2. Allele polymorphisms in the gene promoter of thymidylate synthase (TS) enzyme [ Time Frame: At baseline, which is the day of PDT treatment ]
    Identify the allele combination present at TS locus


Biospecimen Retention:   Samples With DNA
Blood samples will be collected on the date of Photodynamic Therapy. A total of 13.5mL of blood will be collected between 2 tubes (3.5mL gold top tube and a 10 mL lavendar top Vacutainer tube with EDTA). 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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319251


Contacts
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Contact: Jeff Negrey, MA 216-636-5504 negreyj2@ccf.org
Contact: Edward Maytin, MD 216-444-5139 maytine@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jeff Negrey, MA    216-636-5504    negreyj2@ccf.org   
Contact: Michael Macknin, MD    216-444-5512    MACKNIM@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Additional Information:

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Responsible Party: Edward Maytin, MD, PhD, Physician, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03319251    
Other Study ID Numbers: 16-1615
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms