Rheumatoid ArthritisNCT04085471
CTHRC1 Abiomarker in Rheumatoid Arthritis Diagnosis
An observational study of Rheumatoid Arthritis, run by Assiut University.
Trial summary
The purpose of the study is to determine whether plasma levels of the collagen triple helix repeat containing (CTHRC1) protein can serve as a blood-based biomarker for diagnosis of rheumatoid arthritis (RA) ,and furthermore its correlation with disease activity. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- CTHRC1 biomarker level in rheumatoid arthritis
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Dec 2020
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: measurement of CTHRC1in RA patints
Who may be able to join
- -Patients diagnosed as RA.
- Patients ( >18)who are age and sex matched with the controls
Who cannot join
- . Other Rheumatologic diseases. .Patients with malignancy . .Patients with hepatic disease .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: CTHRC1 Apromising Biomarker in Rheumatoid Arthritis Diagnosis
The purpose of the study is to determine whether plasma levels of the collagen triple helix repeat containing (CTHRC1) protein can serve as a blood-based biomarker for diagnosis of rheumatoid arthritis (RA) ,and furthermore its correlation with disease activity.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease of synovial joints. Characterized by periods of flares with high disease activity involving both a systemic immune response and tissue-specific inflammatory events that can lead to erosive joint and bone destruction and subsequent disability . Currently, diagnosis of RA is based mainly on the extent of tenderness and swelling of the joints , levels of acute-phase reactants such as C-reactive protein (CRP) ,erythrocyte sedimentation rate(ESR) , high titers of rheumatoid factor (RF) and high titers of antibodies against cyclic citrullinated peptide (anti-CCP) in the plasma .Of interest, CTHRC1 is a secreted modulator of Wnt signaling, which is a key regulator of joint remodeling, and promotes cell proliferation and migration. Therefore, CTHRC1 may contribute to multiple aspects of the pathogenic FLS behavior in RA and modulate processes that promote synovial hyperplasia and invasion.The expression pattern of CTHRC1 in pannus, its role in the function of FLS relevant to cartilage damage in RA, and CTHRC1's association with disease severity in murine arthritis raised the question of whether CTHRC1 could be used as a marker for RA diagnosis and monitoring of disease activity in patients
- Conditions
- Rheumatoid Arthritis
- Being tested
- CTHRC1 biomarker level in rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTHRC1 biomarker level in rheumatoid arthritisDiagnostic test
measurment of levels of CTHRC1 in patients diagnosed as RA
What is being measured
The primary outcome is the main question the study is designed to answer.
CTHRC1 Apromising biomarker in rheumatoid arthritis diagnosis
measurement of levels of CTHRC1 in rheumatoid arthritis patients
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lobna Amer Araby Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085471
- Sponsor's protocol ID
- rheumatoid arthritis
- Status last verified
- Sep 2019
- First submitted
- 9 Sep 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Myatt GL, Ecobichon DJ, Greenhalgh R. Fenitrooxon and S-methyl fenitrothion: acute toxicity and hydrolysis in mammals. Environ Res. 1975 Dec;10(3):407-14. doi: 10.1016/0013-9351(75)90036-5. No abstract available.
PubMed 2462
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CTHRC1 Apromising Biomarker in Rheumatoid Arthritis Diagnosis
- ClinicalTrials.gov ID
- NCT04085471
- Acronym / sponsor ID
- rheumatoid arthritis
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 11 Sep 2019 (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.
The purpose of the study is to determine whether plasma levels of the collagen triple helix repeat containing (CTHRC1) protein can serve as a blood-based biomarker for diagnosis of rheumatoid arthritis (RA) ,and furthermore its correlation with disease activity.
Detailed description
Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease of synovial joints. Characterized by periods of flares with high disease activity involving both a systemic immune response and tissue-specific inflammatory events that can lead to erosive joint and bone destruction and subsequent disability . Currently, diagnosis of RA is based mainly on the extent of tenderness and swelling of the joints , levels of acute-phase reactants such as C-reactive protein (CRP) ,erythrocyte sedimentation rate(ESR) , high titers of rheumatoid factor (RF) and high titers of antibodies against cyclic citrullinated peptide (anti-CCP) in the plasma .Of interest, CTHRC1 is a secreted modulator of Wnt signaling, which is a key regulator of joint remodeling, and promotes cell proliferation and migration. Therefore, CTHRC1 may contribute to multiple aspects of the pathogenic FLS behavior in RA and modulate processes that promote synovial hyperplasia and invasion.The expression pattern of CTHRC1 in pannus, its role in the function of FLS relevant to cartilage damage in RA, and CTHRC1's association with disease severity in murine arthritis raised the question of whether CTHRC1 could be used as a marker for RA diagnosis and monitoring of disease activity in patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- measurement of CTHRC1in RA patints
Key inclusion criteria (2 listed)
- -Patients diagnosed as RA.
- Patients ( >18)who are age and sex matched with the controls
Key exclusion criteria (1 listed)
- . Other Rheumatologic diseases. .Patients with malignancy . .Patients with hepatic disease .
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 |
|---|---|---|
| CTHRC1 biomarker level in rheumatoid arthritismeasurment of levels of CTHRC1 in patients diagnosed as RA | Diagnostic test | – |
Primary outcome
CTHRC1 Apromising biomarker in rheumatoid arthritis diagnosis
Time frame: one year
measurement of levels of CTHRC1 in rheumatoid arthritis patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Background: PubMed 2462Myatt GL, Ecobichon DJ, Greenhalgh R. Fenitrooxon and S-methyl fenitrothion: acute toxicity and hydrolysis in mammals. Environ Res. 1975 Dec;10(3):407-14. doi: 10.1016/0013-9351(75)90036-5. No abstract available.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Assiut University.
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 1 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 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Lobna Amer Araby, Master (01019313530, lobnaamer20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTHRC1 Apromising biomarker in rheumatoid arthritis diagnosis (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04085471, which also lists 1 linked publication.
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 18 Sep 2019.