Deep Phenotyping of Cutaneous T Cell Lymphoma, Type Mycosis Fungoides (NCT05303480) | Clinical Trial Compass
CompletedNot Applicable
Deep Phenotyping of Cutaneous T Cell Lymphoma, Type Mycosis Fungoides
Netherlands32 participantsStarted 2021-12-07
Plain-language summary
Mycosis fungoides (MF) is an ultra-orphan disease of which the etiology remains unknown. MF is diagnosed by correlating clinical appearance with histopathological analysis of often multiple invasive skin punch biopsies. To move patient care and the development of novel treatments for MF forward, objective, sensitive and reliable tools that are preferably non-invasive are desired. Therefore, the objective of the current study is to phenotype the early stages of mycosis fungoides in detail and to assess the response of chlormethine (CL) gel monotherapy. With this approach the investigators aim to detect novel biomarkers and to establish methodologies for the (non-)invasive monitoring of MF.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed informed consent prior to any study-mandated procedure;
. Male or female subjects, 18 to 75 years of age, inclusive at screening; in general, stable good health as per judgement of the investigator based upon the results of a medical history, physical examination, vital signs, ECG and laboratory assessments performed at screening. Repeated laboratory testing may be performed at the discretion of the clinical investigators;
. Body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m2; during COVID-19 pandemic only ≥ 18.0 and ≤ 33.0 kg/m2;
. No clinically significant skin disease as judged by the investigator;
. No history of hypertrophic scarring or keloid;
. Subject is willing to refrain from extensively washing (including bathing, swimming, showering and excessive sweating) the skin 4 hours before every study visit;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite Assessment of Index Lesions Disease Severity Score (CAILS)
. Subject is willing and able to washout and withhold any topical treatment (prescription and over the counter products) in the treatment area (if possible matched location to most common location of target lesions of the MF group, and otherwise 100cm2 on the lower back) for 2 weeks prior to Day 1;
. Subject is willing to refrain from application of any topical product (e.g. ointments, crème or washing lotions) on the skin 24 hours prior to every study visit day;
Exclusion criteria
. History of immunological abnormality (e.g., immune suppression) that may interfere with study objectives, in the opinion of the investigator;
. The use of systemic antibiotic therapy for \>2 months the past 12 months;
. The use of any oral/systemic medication (e.g. immunomodulatory, immunosuppressive) within 28 days prior to Day 1, if the investigator judges that it may interfere with the study objectives.
. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV ab), or human immunodeficiency virus antibody (HIV ab) at screening;
. Participation in an investigational drug study within 3 months prior to screening or more than 4 times a year;
. Loss or donation of blood over 500mL within three months prior to screening;
. History of alcohol consumption exceeding 5 standard drinks per day on average within 3 months of screening. Alcohol consumption will be prohibited from at least 24 hours preceding each study visit;
. Positive urine test for drugs or history of abuse at screening or pre-dose. Urine drug test may be repeated at the discretion of the investigator;
3D Multispectral imaging
Timeframe: from day 0 to day 155
9
Laser Speckle Contrast Imaging (LSCI)
Timeframe: from day 0 to day 155
10
Thermography
Timeframe: from day 0 to day 155
11
Optical Coherence Tomography (OCT)
Timeframe: from day 0 to day 155
12
Skin barrier function by Trans-Epidermal Water Loss (TEWL)
Timeframe: from day 0 to day 155
13
Cutaneous microbiome
Timeframe: from day 0 to day 155
14
Faecal microbiome
Timeframe: from day 43 to day 155
15
Skin surface biomarkers
Timeframe: from day 0 to day 155
16
Lipidomics of the stratum corneum by liquid chromatography mass spectroscopy
Timeframe: from day 0 to day 155
17
Patient genotyping
Timeframe: day 43
18
Blister immune cell subsets
Timeframe: day 43
19
Blister protein biomarkers by high-throughput, multiplex immunoassays of proteins by Proximity Estension Assay (PEA) technology
Timeframe: day 43
20
Immunohistochemistry and Imaging Mass Cytometry/VECTRA of biopsies
Timeframe: from day 43 to day 155
21
Circulating protein biomarkers by PCR amplification
Timeframe: from day 0 to day 155
22
Cells/ml; Circulating immune cell subsets
Timeframe: from day 0 to day 155
23
Itch Tracking by Derma Track
Timeframe: from day 0 to day 155
24
User experience and subjective burden questionnaire
Timeframe: from day 43 to day 155
25
Blister immune cell subsets during dermatitis reactions
Timeframe: from day 43 to day 155
26
Change from baseline in blister immune cell subsets after 16 weeks of treatment
Timeframe: day 43 and day 155
27
Blister protein biomarkers by high-throughput, multiplex immunoassays of proteins by Proximity Estension Assay (PEA) technology
Timeframe: from day 43 to day 155
28
Change from baseline in blister protein biomarkers, by high-throughput, multiplex immunoassays of proteins by Proximity Estension Assay (PEA) technology