Undifferentiated Connective Tissue DiseasesNCT06399822
Impact of Capillaroscopy on the Management of Undifferentiated Connective Tissue Disease
A study testing Nail capillaroscopy in people with Undifferentiated Connective Tissue Diseases, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
Connective tissue diseases (CTD) are a group of diseases with diverse manifestations, most often multisystemic, which share an autoimmune etiology. They include Systemic lupus erythematosus (SLE), Systemic sclerosis (SSc), Sjögren's syndrome (SS), Inflammatory myopathies (IM) and Mixed connective tissue disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Undifferentiated Connective Tissue Diseases
- What is being tested?
- Nail capillaroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 22 May 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be aged 18 and over;
- Have been diagnosed with undifferentiated connective tissue disease by a rheumatologist;
- Meet the preliminary classification criteria for undifferentiated connective tissue disease: present signs and symptoms suggestive of connective tissue disease, but do not meet the criteria for a connective tissue disease and have a positive antinuclear antibody on at least 2 occasions;
- Have developed the first signs and symptoms of the disease less than 10 years before recruitment.
Who cannot join
- In the opinion of the clinician, have a health condition that does not allow a delay of six months before carrying out the capillaroscopy;
- Have been diagnosed and/or meet the classification criteria for another connective tissue disease (for example, systemic lupus, etc.);
- Have already performed a capillaroscopy in the past, regardless of the time or the reason;
- Be unable to consent or respond to questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
CHU de Quebec-Université Laval
Québec, Quebec, G1V4G2
Laetitia Michou, MD PhD, 418 525 4444 ext. 48383, laetitia.michou@crchudequebec.ulaval.ca
William Berthelot, MD, 418 654 2242, william.berthelot.1@ulaval.ca
About this study
Official title: Impact of Capillaroscopy on the Management of Undifferentiated Connective Tissue Disease: a Randomized Pilot Clinical Study
Connective tissue diseases (CTD) are a group of diseases with diverse manifestations, most often multisystemic, which share an autoimmune etiology. They include Systemic lupus erythematosus (SLE), Systemic sclerosis (SSc), Sjögren's syndrome (SS), Inflammatory myopathies (IM) and Mixed connective tissue disease (MCTD).
Many patients in rheumatology present signs and symptoms of CTD, but without meeting all the classification criteria for one of these diseases. These patients will generally receive a diagnosis of undifferentiated connective tissue disease (UCTD). It is increasingly suggested that there are two subgroups of patients with UCTD: one which will eventually evolve into a better characterized CTD (approximately 30% of patients at 5 years) and another with a more benign prognosis. The optimal management of patients with UCTD is not clearly established.
Read more
Capillaroscopy is a diagnostic test used in the investigation of patients with CTD. It is a low-cost, non-invasive, rapid and specific test in the evaluation of this class of diseases. Its role is now well established in the diagnosis of SSc and in the investigation of Raynaud's phenomenon. In addition, capillaroscopy helps to identify patients suffering from CTD more quickly.
Knowledge about the role of capillaroscopy in UCTD is more limited. It is established that a significant proportion of patients with UCTD present abnormalities on UCTD present non-specific abnormalities and 11% present a scleroderma pattern. In these patients, abnormal capillaroscopy seems to increase the risk of progressing to a better characterized CTD, notably SSc.
However, although capillaroscopy is increasingly used in rheumatology in patients with CTD, more research is needed to clarify the role of this examination in UCTD. First, it is not established whether capillaroscopy should be performed in all patients with UCTD, nor when exactly it should be performed. There also remain questions about the impact of capillaroscopy on the prognosis and management of patients with this disease. To our knowledge, there is no prospective study that has addressed this question. The investigators hypothesize that in patients with UCTD, capillaroscopy compared to usual care makes it possible to increase the proportion of patients obtaining a diagnosis of better characterized CTD in the first six months of follow-up.
Read the detailed description
This is a pilot randomized controlled clinical trial. This monocentric project will be carried out within the rheumatology department of the Quebec university hospital.
The main objective of the project is to determine, in patients with undifferentiated connective tissue disease, to what extent capillaroscopy compared to usual care influences the proportion of patients obtaining a diagnosis of better characterized connective tissue disease in the first six months of follow-up.
The secondary objectives are:
- Determine, in patients with undifferentiated connective tissue disease, to what extent capillaroscopy influences the following factors after capillaroscopy:
- The proportion of patients obtaining a diagnosis of better characterized connective tissue disease at 12 months;
- Medication changes (addition, discontinuation or change in dosage of non-biological disease modifying drugs, biological disease modifying drugs, medications for Raynaud's syndrome and corticosteroids) at 6 and 12 months;
- The number of medical visits in rheumatology, medical visits in specialties other than rheumatology, hospitalizations and emergency medical visits at 6 and 12 months;
- The number of additional examinations (blood samples, radiological examinations or others) carried out which were prescribed by the treating rheumatologist at 6 and 12 months;
- A change in lifestyle habits (smoking, alcohol and drug consumption, physical activity, diet) at 6 and 12 months;
- Patients' quality of life assessed by the health assessment questionnaire, short form survey-36 and Patient-Reported Outcomes Measurement Information System-29 questionnaires at 6 and 12 months;
- Patient acceptability and satisfaction with the intervention under study at 12 months;
- Evaluate the feasibility of recruiting participants in this study (the investigators will measure the number, proportions and rates of patients recruited and retained, as well as the number of individuals screened, eligible and recruited).
The investigators will recruit 40 patients with a diagnosis of undifferentiated connective tissue disease and referred for a capillaroscopy examination in rheumatology as part of clinical practice.
Once recruited, participants will be randomized into two groups, in a 1:1 ratio, stratifying for gender and duration since the onset of the first symptoms of the disease (less than three years and three years and more). The randomization blocks will be generated by the biostatistician.
In the intervention group, a capillaroscopy will be performed in the month following recruitment. In the control group, capillaroscopy will be performed six months (+/- two weeks) after recruitment.
The intervention studied as part of the project is capillaroscopy. This examination consists of visualizing the capillaries located at the base of the nail using a device called a capillaroscope. This device magnifies the image of the capillaries to clearly visualize them. Capillaries are the smallest blood vessels, which allow the passage of only one red blood cell at a time. At the nail bed, they form a network of loops and are aligned next to each other. This alignment allows them to be viewed over their entire length. Researchers have described abnormalities in capillaries that are associated with certain diseases involving microvascular damage.
Participants will be invited to attend an appointment at the outpatient clinic to perform the capillaroscopy. The date of this appointment will depend on the group into which they have been randomized. If they are assigned to the intervention group, capillaroscopy will be performed within one month after inclusion in the study. If they are assigned to the control group, capillaroscopy will be performed six months after inclusion in the study, (+/- two weeks). If the capillaroscopy appointment is missed, a new appointment will be scheduled within two weeks.
The results of capillaroscopy will be reported qualitatively, for all eight long fingers examined. This approach was chosen since it best represents current clinical practice. The capillaroscopy results will therefore be classified into one of the following categories: normal; nonspecific changes; scleroderma pattern; non-diagnostic quality.
- Being tested
- Nail capillaroscopy
- Keywords
- undifferentiated connective tissue disease, capillaroscopy, randomized pilot clinical study
- Medical subject headings
- Undifferentiated Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nail capillaroscopyDiagnostic test
The intervention studied as part of the project is capillaroscopy. This examination consists of visualizing the capillaries located at the base of the nail using a device called a capillaroscope. This device magnifies the image of the capillaries to clearly visualize them. Capillaries are the smallest blood vessels, which allow the passage of only one red blood cell at a time. At the nail bed, they form a network of loops and are aligned next to each other. This alignment allows them to be viewed over their entire length. Researchers have described abnormalities in capillaries that are associated with certain diseases involving microvascular damage.
The results of capillaroscopy will be reported qualitatively, for all eight long fingers examined.
| Study group | Role | What they receive |
|---|---|---|
| Capillaroscopy | Active comparator | In the capillaroscopy group, the capillaroscopy will be performed in the month following recruitment. Receives: Diagnostic Test: Nail capillaroscopy |
| Control | Other | In the control group, the capillaroscopy will be performed six months (+/- 2 weeks) after recruitment. Receives: Diagnostic Test: Nail capillaroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who transitioned from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease
The primary endpoint of the study will be the proportion of participants who transitioned from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease at 6 months.
Measured: 6 months
Secondary outcomes (19)
Proportion of participants who went from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease
The proportion of participants who went from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease at 12 months;
Measured: 12 months
Proportion of participants with a medication change from the baseline visit
The proportion of participants with a medication change from the baseline visit (defined as the addition, discontinuation, or dosage change of nonbiologic disease-modifying drugs, biologic disease-modifying drugs, Raynaud's medications, and corticosteroids) at 6 and 12 months
Measured: 6 and 12 months
Average number of rheumatology medical visits per participant
The average number of rheumatology medical visits per participant at 6 and 12 months (continuous value);
Measured: 6 and 12 months
Average number of medical visits in specialties other than rheumatology per participant
The average number of medical visits in specialties other than rheumatology per participant at 6 and 12 months (continuous value);
Measured: 6 and 12 months
Average number of hospitalizations per participant
The average number of hospitalizations per participant at 6 and 12 months (continuous value);
Measured: 6 and 12 months
Average number of emergency room visits per participant
The average number of emergency room visits per participant at 6 and 12 months (continuous value);
Measured: 6 and 12 months
Average number of additional examinations
The average number of additional examinations (blood samples, radiological examinations or others) which were prescribed by the treating rheumatologist per participant at 6 and 12 months (continuous value);
Measured: 6 and 12 months
Proportion of patients with a healthy weight
The proportion of patients with a healthy weight (body mass index of 18.5 to 24.9);
Measured: 6 and 12 months
Average number of alcohol drinks (standard drinks) consumed per week and per participant
The average number of alcohol drinks (standard drinks) consumed per week and per participant at 6 and 12 months (continuous value);
Measured: 6 and 12 months
Proportion of patients who are active smokers, former smokers and have never smoked
Smoking status (i.e. the proportion of patients who are active smokers, former smokers and have never smoked) at 6 and 12 months;
Measured: 6 and 12 months
Average number of cigarettes smoked per day per participant
The average number of cigarettes smoked per day per participant at 6 and 12 months (continuous value);
Measured: 6 and 12 months
Proportion of participants using tobacco products other than cigarettes
The proportion of participants using tobacco products other than cigarettes at 6 and 12 months;
Measured: 6 and 12 months
Proportion of participants using cannabis products
The proportion of participants using cannabis products at 6 and 12 months;
Measured: 6 and 12 months
Proportion of participants using drugs other than cannabis
The proportion of participants using drugs other than cannabis at 6 and 12 months;
Measured: 6 and 12 months
Average number of minutes of moderate to high intensity aerobic physical activity performed per week and per participant
The average number of minutes of moderate to high intensity aerobic physical activity performed per week and per participant at 6 and 12 months (continuous value);
Measured: 6 and 12 months
Proportion of participants who reported adopting a diet following the healthy eating recommendations of Canada's Food Guide
The proportion of participants who reported adopting a diet following the healthy eating recommendations of Canada's Food Guide at 6 and 12 months.
Measured: 6 and 12 months
Average score on the Health Assessment Questionnaire
The average score on the Health Assessment Questionnaire (from 0 to 3, with 3 decimal places);
Measured: 6 and 12 months
Average score for the eight components of the Short form survey 36 questionnaire
The average score for the eight components of the short form survey 36 questionnaire (from 0 to 100, with 2 decimal places): (1) physical functioning, (2) role limitations due to physical health problems, (3) bodily pain, (4) general health perceptions, (5) energy/fatigue, (6) social functioning, (7) role limitations due to personal or emotional problems and (8) emotional well-being;
Measured: 6 and 12 months
Average score on the eight components of the Patient-Reported Outcomes Measurement Information System29 scale
The average score on the eight components of the Patient-Reported Outcomes Measurement Information System29 scale (without decimal): (1) physical function (4 to 20), (2) anxiety (4 to 20), (3) depression (4 to 20), (4) fatigue (4 to 20), (5) sleep disturbances (4 to 20), (6) ability to participate in social roles and activities (4 to 20), (7) ) pain interference (4 to 20) and (8) pain intensity (0 to 10).
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start22 May 2024
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undifferentiated Connective Tissue DiseasesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laetitia Michou, MD PhD, Principal investigator, CHU de Quebec (Université Laval)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399822
- Sponsor's protocol ID
- 2024-7303
- Status last verified
- Mar 2026
- First submitted
- 22 Apr 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Capillaroscopy on the Management of Undifferentiated Connective Tissue Disease: a Randomized Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT06399822
- Acronym / sponsor ID
- 2024-7303
- Keywords
- undifferentiated connective tissue disease, capillaroscopy, randomized pilot clinical study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 May 2024 (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.
Connective tissue diseases (CTD) are a group of diseases with diverse manifestations, most often multisystemic, which share an autoimmune etiology. They include Systemic lupus erythematosus (SLE), Systemic sclerosis (SSc), Sjögren's syndrome (SS), Inflammatory myopathies (IM) and Mixed connective tissue disease (MCTD).
Many patients in rheumatology present signs and symptoms of CTD, but without meeting all the classification criteria for one of these diseases. These patients will generally receive a diagnosis of undifferentiated connective tissue disease (UCTD). It is increasingly suggested that there are two subgroups of patients with UCTD: one which will eventually evolve into a better characterized CTD (approximately 30% of patients at 5 years) and another with a more benign prognosis. The optimal management of patients with UCTD is not clearly established.
Capillaroscopy is a diagnostic test used in the investigation of patients with CTD. It is a low-cost, non-invasive, rapid and specific test in the evaluation of this class of diseases. Its role is now well established in the diagnosis of SSc and in the investigation of Raynaud's phenomenon. In addition, capillaroscopy helps to identify patients suffering from CTD more quickly.
Knowledge about the role of capillaroscopy in UCTD is more limited. It is established that a significant proportion of patients with UCTD present abnormalities on UCTD present non-specific abnormalities and 11% present a scleroderma pattern. In these patients, abnormal capillaroscopy seems to increase the risk of progressing to a better characterized CTD, notably SSc.
However, although capillaroscopy is increasingly used in rheumatology in patients with CTD, more research is needed to clarify the role of this examination in UCTD. First, it is not established whether capillaroscopy should be performed in all patients with UCTD, nor when exactly it should be performed. There also remain questions about the impact of capillaroscopy on the prognosis and management of patients with this disease. To our knowledge, there is no prospective study that has addressed this question. The investigators hypothesize that in patients with UCTD, capillaroscopy compared to usual care makes it possible to increase the proportion of patients obtaining a diagnosis of better characterized CTD in the first six months of follow-up.
Detailed description
This is a pilot randomized controlled clinical trial. This monocentric project will be carried out within the rheumatology department of the Quebec university hospital.
The main objective of the project is to determine, in patients with undifferentiated connective tissue disease, to what extent capillaroscopy compared to usual care influences the proportion of patients obtaining a diagnosis of better characterized connective tissue disease in the first six months of follow-up.
The secondary objectives are:
- Determine, in patients with undifferentiated connective tissue disease, to what extent capillaroscopy influences the following factors after capillaroscopy:
- The proportion of patients obtaining a diagnosis of better characterized connective tissue disease at 12 months;
- Medication changes (addition, discontinuation or change in dosage of non-biological disease modifying drugs, biological disease modifying drugs, medications for Raynaud's syndrome and corticosteroids) at 6 and 12 months;
- The number of medical visits in rheumatology, medical visits in specialties other than rheumatology, hospitalizations and emergency medical visits at 6 and 12 months;
- The number of additional examinations (blood samples, radiological examinations or others) carried out which were prescribed by the treating rheumatologist at 6 and 12 months;
- A change in lifestyle habits (smoking, alcohol and drug consumption, physical activity, diet) at 6 and 12 months;
- Patients' quality of life assessed by the health assessment questionnaire, short form survey-36 and Patient-Reported Outcomes Measurement Information System-29 questionnaires at 6 and 12 months;
- Patient acceptability and satisfaction with the intervention under study at 12 months;
- Evaluate the feasibility of recruiting participants in this study (the investigators will measure the number, proportions and rates of patients recruited and retained, as well as the number of individuals screened, eligible and recruited).
The investigators will recruit 40 patients with a diagnosis of undifferentiated connective tissue disease and referred for a capillaroscopy examination in rheumatology as part of clinical practice.
Once recruited, participants will be randomized into two groups, in a 1:1 ratio, stratifying for gender and duration since the onset of the first symptoms of the disease (less than three years and three years and more). The randomization blocks will be generated by the biostatistician.
In the intervention group, a capillaroscopy will be performed in the month following recruitment. In the control group, capillaroscopy will be performed six months (+/- two weeks) after recruitment.
The intervention studied as part of the project is capillaroscopy. This examination consists of visualizing the capillaries located at the base of the nail using a device called a capillaroscope. This device magnifies the image of the capillaries to clearly visualize them. Capillaries are the smallest blood vessels, which allow the passage of only one red blood cell at a time. At the nail bed, they form a network of loops and are aligned next to each other. This alignment allows them to be viewed over their entire length. Researchers have described abnormalities in capillaries that are associated with certain diseases involving microvascular damage.
Participants will be invited to attend an appointment at the outpatient clinic to perform the capillaroscopy. The date of this appointment will depend on the group into which they have been randomized. If they are assigned to the intervention group, capillaroscopy will be performed within one month after inclusion in the study. If they are assigned to the control group, capillaroscopy will be performed six months after inclusion in the study, (+/- two weeks). If the capillaroscopy appointment is missed, a new appointment will be scheduled within two weeks.
The results of capillaroscopy will be reported qualitatively, for all eight long fingers examined. This approach was chosen since it best represents current clinical practice. The capillaroscopy results will therefore be classified into one of the following categories: normal; nonspecific changes; scleroderma pattern; non-diagnostic quality.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capillaroscopy | Active comparator | Diagnostic Test: Nail capillaroscopyIn the capillaroscopy group, the capillaroscopy will be performed in the month following recruitment. |
| Control | Other | Diagnostic Test: Nail capillaroscopyIn the control group, the capillaroscopy will be performed six months (+/- 2 weeks) after recruitment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be aged 18 and over;
- Have been diagnosed with undifferentiated connective tissue disease by a rheumatologist;
- Meet the preliminary classification criteria for undifferentiated connective tissue disease: present signs and symptoms suggestive of connective tissue disease, but do not meet the criteria for a connective tissue disease and have a positive antinuclear antibody on at least 2 occasions;
- Have developed the first signs and symptoms of the disease less than 10 years before recruitment.
Key exclusion criteria (4 listed)
- In the opinion of the clinician, have a health condition that does not allow a delay of six months before carrying out the capillaroscopy;
- Have been diagnosed and/or meet the classification criteria for another connective tissue disease (for example, systemic lupus, etc.);
- Have already performed a capillaroscopy in the past, regardless of the time or the reason;
- Be unable to consent or respond to questionnaires.
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 |
|---|---|---|
| Nail capillaroscopyThe intervention studied as part of the project is capillaroscopy. This examination consists of visualizing the capillaries located at the base of the nail using a device called a capillaroscope. This device magnifies the image of the capillaries to clearly visualize them. Capillaries are the smallest blood vessels, which allow the passage of only one red blood cell at a time. At the nail bed, they form a network of loops and are aligned next to each other. This alignment allows them to be viewed over their entire length. Researchers have described abnormalities in capillaries that are associated with certain diseases involving microvascular damage. The results of capillaroscopy will be reported qualitatively, for all eight long fingers examined. | Diagnostic test | Capillaroscopy, Control |
Primary outcome
Proportion of participants who transitioned from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease
Time frame: 6 months
The primary endpoint of the study will be the proportion of participants who transitioned from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease at 6 months.
19 secondary outcomes
Proportion of participants who went from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease
Time frame: 12 months
Proportion of participants with a medication change from the baseline visit
Time frame: 6 and 12 months
Average number of rheumatology medical visits per participant
Time frame: 6 and 12 months
Average number of medical visits in specialties other than rheumatology per participant
Time frame: 6 and 12 months
Average number of hospitalizations per participant
Time frame: 6 and 12 months
Average number of emergency room visits per participant
Time frame: 6 and 12 months
Average number of additional examinations
Time frame: 6 and 12 months
Proportion of patients with a healthy weight
Time frame: 6 and 12 months
Average number of alcohol drinks (standard drinks) consumed per week and per participant
Time frame: 6 and 12 months
Proportion of patients who are active smokers, former smokers and have never smoked
Time frame: 6 and 12 months
Average number of cigarettes smoked per day per participant
Time frame: 6 and 12 months
Proportion of participants using tobacco products other than cigarettes
Time frame: 6 and 12 months
Proportion of participants using cannabis products
Time frame: 6 and 12 months
Proportion of participants using drugs other than cannabis
Time frame: 6 and 12 months
Average number of minutes of moderate to high intensity aerobic physical activity performed per week and per participant
Time frame: 6 and 12 months
Proportion of participants who reported adopting a diet following the healthy eating recommendations of Canada's Food Guide
Time frame: 6 and 12 months
Average score on the Health Assessment Questionnaire
Time frame: 6 and 12 months
Average score for the eight components of the Short form survey 36 questionnaire
Time frame: 6 and 12 months
Average score on the eight components of the Patient-Reported Outcomes Measurement Information System29 scale
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- The established and evolving role of nailfold capillaroscopy in connective-tissue diseaseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Laetitia Michou, MD PhD principal investigator
CHU de Quebec (Université Laval)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nail capillaroscopy in people with Undifferentiated Connective Tissue Diseases, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laetitia Michou, MD PhD (418-525-4444 ext. 48383, laetitia.michou@crchudequebec.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who transitioned from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease (time frame: 6 months). 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 17 Mar 2026.