Condition category
Cancer
Date applied
17/11/2019
Date assigned
19/11/2019
Last edited
19/11/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Iris Wohlmuth-Wieser

ORCID ID

http://orcid.org/0000-0003-4714-838X

Contact details

2075 Bayview Ave
Toronto
M4N 3M5
Canada
+1 416 4804908
iris.wohlmuthwieser@sunnybrook.ca

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

299-2019

Study information

Scientific title

The implementation of novel imaging techniques for the evaluation of cutaneous lymphomas

Acronym

ITCL

Study hypothesis

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

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

Study design

Prospective single-center observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

No participant information sheet available

Condition

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 names

Vevo MD® ultrasound machine

Primary outcome measure

Ultrasound characteristics (morphology of the epidermis, dermis and subcutis) for mycosis fungoides measured using the Vevo MD® ultrasound machine at the time of investigation

Secondary outcome measures

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

Overall trial start date

01/11/2019

Overall trial end date

30/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patch or plaque stage mycosis fungoides

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

30

Total final enrolment

30

Participant exclusion criteria

1. Clinical suspicion of mycosis fungoides lacking definitive histopathologic proof
2. Mycosis fungoides with generalized erythroderma

Recruitment start date

01/12/2019

Recruitment end date

30/06/2021

Locations

Countries of recruitment

Canada

Trial participating centre

Sunnybrook Health Sciences Centre
2075 Bayview Avenue
Toronto, ON
M4N 3M5
Canada

Sponsor information

Organisation

Sunnybrook Health Sciences Centre

Sponsor details

2075 Bayview Ave
Toronto
M4N 3M5
Canada
+1 416 480 4908
lyn.sarceda@sunnybrook.ca

Sponsor type

Hospital/treatment centre

Website

https://sunnybrook.ca

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to publish our data in a pubmed-listed journal.

The study protocol is available on request from the study contacts.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/08/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

19/11/2019: Trial’s existence confirmed by Research Ethics Board, Sunnybrook Health Sciences Centre.