Using ultrasound to evaluate white blood cell cancer in the skin
| ISRCTN | ISRCTN14038061 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14038061 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 299-2019 |
| Sponsor | Sunnybrook Health Sciences Centre |
| Funder | Investigator initiated and funded |
- Submission date
- 17/11/2019
- Registration date
- 19/11/2019
- Last edited
- 03/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Mycosis fungoides is the most common form of a type of blood cancer called cutaneous T-cell lymphoma. Cutaneous T-cell lymphomas occur when certain white blood cells, called T cells, become cancerous; these cancers characteristically affect the skin, causing different types of skin lesions.
The diagnosis of Mycosis fungoides is often delayed since the skin lesions look similar to other skin diseases. While in many cases a diagnosis of skin diseases can be made clinically and does not require a skin biopsy, the diagnosis of Mycosis fungoides requires a skin biopsy and sometimes many skin biopsies are needed to make the correct diagnosis.
A possible new method for diagnosis is skin ultrasound, which is a fast method (done within minutes) and causes no harm or pain.
Who can participate?
Patients who have been diagnosed with Mycosis fungoides.
What does the study involve?
The study involves the application of ultrasound and dermoscopy (as non-invasive techniques) for the assessment of cutaneous lymphoma lesions.
What are the possible benefits and risks of participating?
There are no direct benefits for the patients and no potential risks of participation are anticipated.
Where is the study run from?
Sunnybrook Health Sciences Centre, Toronto, Canada
When is the study starting and how long is it expected to run for?
December 2019 to June 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Iris Wohlmuth-Wieser
iris.wohlmuthwieser@sunnybrook.ca
Dr Raed Alhusayen
raed.alhusayen@sunnybrook.ca
Contact information
Scientific
2075 Bayview Ave
Toronto
M4N 3M5
Canada
 ORCID ID |
0000-0003-4714-838X |
|---|---|
| Phone | +1 416 4804908 |
| iris.wohlmuthwieser@sunnybrook.ca |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective single-center observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | The implementation of novel imaging techniques for the evaluation of cutaneous lymphomas |
| Study acronym | ITCL |
| Study objectives | The aim of the study is to prospectively obtain high-frequency ultrasound images (HF-USG) in MF patients of different stages of the disease, in order to describe baseline HF-USG criteria for MF and to compare the HF-USG images with dermoscopy and macroscopic images from the same index skin lesion |
| Ethics approval(s) | Approved 29/10/2019, Research Ethics Board, Sunnybrook Health Sciences Centre (2075 Bayview Ave, Toronto, M4N 3M5, Ontario, Canada; +1 416-480-6100; monica.hung@sunnybrook.ca), ref: 299-2019 |
| Health condition(s) or problem(s) studied | Mycosis fungoides (cutaneous lymphoma) |
| Intervention | The study is designed to investigate the applicability of HF-USG in patients with mycosis fungoides using Vevo MD®; FUJIFILM VisualSonics, Toronto, ON, Canada ultrasound machine and to describe baseline ultrasound charateristics for mycosis fungoides and to compare these findings with standard dermoscopy. Non-invasive standard dermoscopy and ultrasound images will be obtained from an index lesion of the patient. The patient will remain under standard of care. There will be no additional biopsies obtained for study purposes. The investigators will only take non-invasive images as described above, thus not imposing any potential harm to the patient. The total duration of the observation is expected to take 30 minutes (one single visit). No follow-up visits are planned for this study. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Vevo MD® ultrasound machine |
| Primary outcome measure(s) |
Ultrasound characteristics (morphology of the epidermis, dermis and subcutis) for mycosis fungoides measured using the Vevo MD® ultrasound machine at the time of investigation |
| Key secondary outcome measure(s) |
Dermoscopy characteristics (pattern of the skin lesion including the morphology of vessels, follicular openings and the color of scales) for mycosis fungoides measured using skin surface microspcopy at the time of investigation |
| Completion date | 30/06/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | Patch or plaque stage mycosis fungoides |
| Key exclusion criteria | 1. Clinical suspicion of mycosis fungoides lacking definitive histopathologic proof 2. Mycosis fungoides with generalized erythroderma |
| Date of first enrolment | 01/12/2019 |
| Date of final enrolment | 30/06/2021 |
Locations
Countries of recruitment
- Canada
Study participating centre
Toronto, ON
M4N 3M5
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 23/12/2020 | 03/01/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
03/01/2023: Publication reference added.
19/11/2019: Trial’s existence confirmed by Research Ethics Board, Sunnybrook Health Sciences Centre.
