CTCL/ Mycosis FungoidesNCT04491825
Diagnostic Classifier for Cutaneous T-cell Lymphomas
An observational study of CTCL/ Mycosis Fungoides, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Primary cutaneous T-cell lymphomas (CTCL) are a form of skin cancer that is derived from immune cells. The most common form of CTCL is mycosis fungoides (MF). While initially confined to the skin, MF may spread to lymph nodes, blood or inner organs, resulting in an overall poor prognosis for the patient. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- CTCL/ Mycosis Fungoides
- What is being tested?
- Skin suction blistering and skin biopsies
- How many people
- 160 participants
- Where
- 1 siteAustria
- Study dates
- 22 Feb 2021to 30 Jun 2024
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: MF patients need prior histopathological verification of their disease. Eczema and psoriasis patients will be diagnosed clinically and, if necessary, on a histopathological basis.
Who may be able to join
- Clinical and/or histopathological diagnosis of MF, eczema or psoriasis
- Healthy control subjects without personal history of MF, eczema or psoriasis
Who cannot join
- Ongoing skin-targeted treatment (Wash out times: 2 weeks for topical, and 4 weeks for systemic treatments)
- Ongoing other treatment that might, in the opinion of the investigator, influence proteomic features of the samples to be acquired
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Patrick Brunner, MD, MSc, +436644605954, patrick.brunner@meduniwien.ac.at
About this study
Primary cutaneous T-cell lymphomas (CTCL) are a form of skin cancer that is derived from immune cells. The most common form of CTCL is mycosis fungoides (MF). While initially confined to the skin, MF may spread to lymph nodes, blood or inner organs, resulting in an overall poor prognosis for the patient. Thus, being a potentially lethal disease, an early and correct diagnosis of MF has very important implications for the patient. However, diagnosis of early MF is often difficult, as it usually shows a close resemblance to benign inflammatory conditions such as eczema and psoriasis. Strikingly, it takes an average of 3-6 (!) years from the appearance of the first skin lesions until a diagnosis of MF can be made. For this reason, a test to distinguishing early MF from benign inflammatory conditions is urgently mandated. By using skin suction blister fluid as well as skin biopsies from patients with MF, eczema and psoriasis, the investigators want to develop a classifier system that can distinguish early MF from benign inflammatory skin diseases.
- Conditions
- CTCL/ Mycosis Fungoides
- Being tested
- Skin suction blistering and skin biopsies
- Medical subject headings
- Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin suction blistering and skin biopsiesDiagnostic test
Skin suction blistering and skin biopsies will be used for the identification of potential proteomic biomarkers that can distinguish MF from eczema, psoriasis and healthy control skin.
| Study group | Role | What they receive |
|---|---|---|
| Mycosis fungoides (MF) | Not described Receives: Diagnostic Test: Skin suction blistering and skin biopsies | |
| Eczema (Atopic Dermatitis) | Not described Receives: Diagnostic Test: Skin suction blistering and skin biopsies | |
| Chronic Plaque-Psoriasis | Not described Receives: Diagnostic Test: Skin suction blistering and skin biopsies | |
| Healthy Control Skin | Not described Receives: Diagnostic Test: Skin suction blistering and skin biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomic signature of MF in comparison to eczema, psoriasis, and healthy control skin
Proteomic multiplex assay
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start22 Feb 2021
- Primary completion22 Feb 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTCL/ Mycosis FungoidesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick M. Brunner, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491825
- Sponsor's protocol ID
- CTCL_Classifier_KLIF
- Status last verified
- Apr 2022
- First submitted
- 23 Jul 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Classifier for Cutaneous T-cell Lymphomas
- ClinicalTrials.gov ID
- NCT04491825
- Acronym / sponsor ID
- CTCL_Classifier_KLIF
- Conditions
- CTCL/ Mycosis Fungoides
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 22 Feb 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 29 Jul 2020 (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.
Primary cutaneous T-cell lymphomas (CTCL) are a form of skin cancer that is derived from immune cells. The most common form of CTCL is mycosis fungoides (MF). While initially confined to the skin, MF may spread to lymph nodes, blood or inner organs, resulting in an overall poor prognosis for the patient. Thus, being a potentially lethal disease, an early and correct diagnosis of MF has very important implications for the patient. However, diagnosis of early MF is often difficult, as it usually shows a close resemblance to benign inflammatory conditions such as eczema and psoriasis. Strikingly, it takes an average of 3-6 (!) years from the appearance of the first skin lesions until a diagnosis of MF can be made. For this reason, a test to distinguishing early MF from benign inflammatory conditions is urgently mandated. By using skin suction blister fluid as well as skin biopsies from patients with MF, eczema and psoriasis, the investigators want to develop a classifier system that can distinguish early MF from benign inflammatory skin diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mycosis fungoides (MF) | – | Diagnostic Test: Skin suction blistering and skin biopsies |
| Eczema (Atopic Dermatitis) | – | Diagnostic Test: Skin suction blistering and skin biopsies |
| Chronic Plaque-Psoriasis | – | Diagnostic Test: Skin suction blistering and skin biopsies |
| Healthy Control Skin | – | Diagnostic Test: Skin suction blistering and skin biopsies |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- MF patients need prior histopathological verification of their disease. Eczema and psoriasis patients will be diagnosed clinically and, if necessary, on a histopathological basis.
Key inclusion criteria (2 listed)
- Clinical and/or histopathological diagnosis of MF, eczema or psoriasis
- Healthy control subjects without personal history of MF, eczema or psoriasis
Key exclusion criteria (2 listed)
- Ongoing skin-targeted treatment (Wash out times: 2 weeks for topical, and 4 weeks for systemic treatments)
- Ongoing other treatment that might, in the opinion of the investigator, influence proteomic features of the samples to be acquired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin suction blistering and skin biopsiesSkin suction blistering and skin biopsies will be used for the identification of potential proteomic biomarkers that can distinguish MF from eczema, psoriasis and healthy control skin. | Diagnostic test | Chronic Plaque-Psoriasis, Eczema (Atopic Dermatitis), Healthy Control Skin, Mycosis fungoides (MF) |
Primary outcome
Proteomic signature of MF in comparison to eczema, psoriasis, and healthy control skin
Time frame: At baseline
Proteomic multiplex assay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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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.
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 CTCL/ Mycosis Fungoides, run by Medical University of Vienna at 1 site in Austria.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Apr 2022. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick M Brunner, MD, MSc (+43140400 ext. 77020, patrick.brunner@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomic signature of MF in comparison to eczema, psoriasis, and healthy control skin (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2022.