Age
Child to Adult
Eligibility
Protocol Definitions:
For the purposes of this protocol, the following definitions apply:
Skin-directed therapies: Topical steroids (prescription or over the counter), intralesional steroids, emollients, retinoids, topical vitamin D analogues, topical PDE4 inhibitors, topical calcineurin inhibitors, imiquimod, resiquimod, phototherapy, and radiation therapy*
Systemic therapies: Oral or intramuscular steroids, oral retinoids, oral vitamin D analogues, HDAC inhibitors, immunomodulatory drugs (including methotrexate), JAK inhibitors, PDE4 inhibitors, rexinoids and PI3K inhibitors*
*Questions about specific therapies should be directed to the Sponsor.
Inclusion Criteria
Note: there are three distinct cohorts for this study. Patient must meet all criteria listed under "All Cohorts" AND for
either Cohort 1, Cohort 2, or Cohort 3.
All Cohorts
1. Patient who, in the opinion of the Investigator, has a diagnosis of MF confirmed or supported by tissue biopsy.
2. Patient who is willing and able to provide new skin samples via superficial scraping as described in this protocol, including at least one affected and a non-affected area.
3. Patient who is between the ages of 2 and 89 at the time of enrollment.
4. Patient or their parent, guardian, or legally authorized representative (LAR) who is willing and able to provide informed consent.
Cohort One: Patient must meet the following inclusion criterion
5. Patient who has not utilized any skin-directed treatments or systemic therapies listed in Protocol Definitions in the two weeks prior to enrollment.
(Note: skin-directed therapies need to be avoided ONLY in areas chosen for sample collection).
Cohort Two: Patient must meet the following inclusion criteria.
6. Patient who is currently utilizing skin-directed treatments and/or systemic therapies listed in Protocol Definitions and who is not willing or who the Investigator does not recommend a two-week washout period prior to sample collection.
Cohort Three: Patient must meet the following inclusion criteria:
7. Patient who is 18 years or older at the time of enrollment and willing and able to provide informed consent.
8. Patient who is currently utilizing skin-directed treatments and/or systemic therapies listed in Protocol Definitions and is willing and able to complete a two-week washout period prior to sample collection (Visit 2).
(Note: skin-directed therapies need to be avoided ONLY in areas chosen for sample collection).
Exclusion Criteria
For all Cohorts:
1. Patient who is a direct employee, student and/or family member of the Investigator.
2. Patient or their parent, guardian, or LAR who is unwilling or unable to provide informed consent.
3. Patient who is currently (including the 6 months prior to enrollment) being treated for lymphoma or leukemia, other than the disease under study.
4. Patient who is currently (including the 6 months prior to enrollment) being treated with chemotherapy for a condition other than the disease under study.
5. Patient who has diagnosis of any type of invasive solid tumor malignancy, with the exception of the following:*
a. Cutaneous squamous cell carcinoma (cSCC) or basal cell carcinoma (BCC) considered by the investigator to be cured through surgical removal at the time of consent for study participation.
b. Non-metastatic cancer with treatment complete and no extension of disease at the time of consent.
6. Patients previously or currently enrolled in a blinded clinical research study, for whom unblinded treatment information is not available at time of enrollment in this study.
For Cohort 3:
1. Patient who is younger than 18 years old.
2. Patient who is unable to provide informed consent.
*Questions about specific patients should be directed to the Sponsor prior to enrollment.
