PsoriasisSCCAPSONCT04308616
Utility of Squamous Cell Carcinoma Antigen (SCCA) in Psoriasis
An observational study of Psoriasis, run by University Hospital, Tours at 1 site in France.
Trial summary
Squamous Cell Carcinoma Antigen (SCCA) contributes to the pathogenesis of psoriasis by inhibiting cell apoptosis, exacerbating epidermal hyperplasia and skin inflammation. Three studies have shown a correlation between blood levels of SCCA and the severity of psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Blood samples
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2020to 27 Apr 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with psoriasis
Who may be able to join
- Age ≥ 18 years old
- Patient with skin psoriasis (new and untreated or being treated, flare-up or stable, possibly bleached)
- Requiring a blood sample for disease or treatment monitoring
Who cannot join
- History of invasive mucosal squamous cell carcinoma, or squamous cell carcinoma of the skin with lymph node or visceral recurrence.
- Patient under guardianship or curatorship
- Opposition to participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Squamous Cell Carcinoma Antigen (SCCA) contributes to the pathogenesis of psoriasis by inhibiting cell apoptosis, exacerbating epidermal hyperplasia and skin inflammation. Three studies have shown a correlation between blood levels of SCCA and the severity of psoriasis.
Clinical scores of psoriasis severity are used in consultation to guide treatment of the disease (initiation of systemic therapy, dose escalation) but they suffer from several pitfalls: lack of inter- and intra-observer reproducibility, consumption of medical time.
A readily available, inexpensive (24 euros) blood marker could be an interesting alternative to these clinical scores.
Read the detailed description
Squamous Cell Carcinoma Antigen (SCCA) contributes to the pathogenesis of psoriasis by inhibiting cell apoptosis, exacerbating epidermal hyperplasia and skin inflammation. Three studies have shown a correlation between blood levels of SCCA and the severity of psoriasis.
Clinical scores of psoriasis severity are used in consultation to guide treatment of the disease (initiation of systemic therapy, dose escalation). The PASI (Psoriasis Assessment Severity Index, minimum score 0, maximum 72) is the most widely used. It suffers from several pitfalls: lack of inter- and intra-observer reproducibility, consumption of medical time. This PASI score was "unavoidable" in the international clinical studies used to obtain marketing authorisation for medicines. The PGA (Physician global assessment) is simpler and less time-consuming, ranging from 0 to 4, but is not very discriminating. More recently, a "Simplified Psoriasis Index" (proSPI) health professional score has been developed, which correlates well with PASI for the severity component of psoriasis and with quality of life for the psychological component of the disease. It is less time-consuming to establish than PASI, but suffers like all clinical scores from a problem of inter- and intra-observer reproducibility.
A readily available, inexpensive (24 euros) blood marker could be an interesting alternative to these clinical scores.
- Conditions
- Psoriasis
- Being tested
- Blood samples
- Keywords
- Psoriasis, Squamous Cell Carcinoma Antigen, SCCA, Biomarker
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Blood samples
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis | Patients with psoriasis Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCCA blood concentration
SCCA blood concentration will be measured at each visit
Measured: Baseline, 3 months and 6 months
Secondary outcomes (5)
Assess correlations between SCCA blood concentration and proSPI severity score
proSPI severity score (0-50) will be evaluated at each visit
Measured: Baseline, 3 months and 6 months
Assess correlations between SCCA blood concentration and proSPI psychosocial score
proSPI psychosocial score (0-10) will be evaluated at each visit
Measured: Baseline, 3 months and 6 months
Assess correlations between SCCA blood concentration and proSPI treatment score
proSPI treatment score (0-10) will be evaluated at each visit
Measured: Baseline, 3 months and 6 months
Assess correlations between SCCA blood concentration and C reactive protein (CRP)
CRP will be measured at each visit
Measured: Baseline, 3 months and 6 months
Assess correlations between SCCA blood concentration and neutrophil/lymphocyte ratio
neutrophil/lymphocyte ratio will be measured at each visit
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start20 Jul 2020
- Primary completion27 Apr 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent MACHET, MD-PhD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308616
- Sponsor's protocol ID
- RIPH3-RNI19/SCCAPSO
- Other IDs
- 2020-A00105-34
- Acronym
- SCCAPSO
- Status last verified
- May 2022
- First submitted
- 5 Mar 2020
- Last updated
- 1 Jun 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 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Squamous Cell Carcinoma Antigen (SCCA) in Psoriasis
- ClinicalTrials.gov ID
- NCT04308616
- Acronym / sponsor ID
- SCCAPSO / RIPH3-RNI19/SCCAPSO
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Squamous Cell Carcinoma Antigen, SCCA, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 16 Mar 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.
Squamous Cell Carcinoma Antigen (SCCA) contributes to the pathogenesis of psoriasis by inhibiting cell apoptosis, exacerbating epidermal hyperplasia and skin inflammation. Three studies have shown a correlation between blood levels of SCCA and the severity of psoriasis.
Clinical scores of psoriasis severity are used in consultation to guide treatment of the disease (initiation of systemic therapy, dose escalation) but they suffer from several pitfalls: lack of inter- and intra-observer reproducibility, consumption of medical time.
A readily available, inexpensive (24 euros) blood marker could be an interesting alternative to these clinical scores.
Detailed description
Squamous Cell Carcinoma Antigen (SCCA) contributes to the pathogenesis of psoriasis by inhibiting cell apoptosis, exacerbating epidermal hyperplasia and skin inflammation. Three studies have shown a correlation between blood levels of SCCA and the severity of psoriasis.
Clinical scores of psoriasis severity are used in consultation to guide treatment of the disease (initiation of systemic therapy, dose escalation). The PASI (Psoriasis Assessment Severity Index, minimum score 0, maximum 72) is the most widely used. It suffers from several pitfalls: lack of inter- and intra-observer reproducibility, consumption of medical time. This PASI score was "unavoidable" in the international clinical studies used to obtain marketing authorisation for medicines. The PGA (Physician global assessment) is simpler and less time-consuming, ranging from 0 to 4, but is not very discriminating. More recently, a "Simplified Psoriasis Index" (proSPI) health professional score has been developed, which correlates well with PASI for the severity component of psoriasis and with quality of life for the psychological component of the disease. It is less time-consuming to establish than PASI, but suffers like all clinical scores from a problem of inter- and intra-observer reproducibility.
A readily available, inexpensive (24 euros) blood marker could be an interesting alternative to these clinical scores.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriasis | – | Other: Blood samplesPatients with psoriasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with psoriasis
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Patient with skin psoriasis (new and untreated or being treated, flare-up or stable, possibly bleached)
- Requiring a blood sample for disease or treatment monitoring
Key exclusion criteria (3 listed)
- History of invasive mucosal squamous cell carcinoma, or squamous cell carcinoma of the skin with lymph node or visceral recurrence.
- Patient under guardianship or curatorship
- Opposition to participation in the study
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 |
|---|---|---|
| Blood samplesBlood samples | Other | Psoriasis |
Primary outcome
SCCA blood concentration
Time frame: Baseline, 3 months and 6 months
SCCA blood concentration will be measured at each visit
5 secondary outcomes
Assess correlations between SCCA blood concentration and proSPI severity score
Time frame: Baseline, 3 months and 6 months
Assess correlations between SCCA blood concentration and proSPI psychosocial score
Time frame: Baseline, 3 months and 6 months
Assess correlations between SCCA blood concentration and proSPI treatment score
Time frame: Baseline, 3 months and 6 months
Assess correlations between SCCA blood concentration and C reactive protein (CRP)
Time frame: Baseline, 3 months and 6 months
Assess correlations between SCCA blood concentration and neutrophil/lymphocyte ratio
Time frame: Baseline, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 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.
Laurent MACHET, MD-PhD principal investigator
University Hospital, Tours
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 Psoriasis, run by University Hospital, Tours at 1 site in France.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 1 Jun 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCCA blood concentration (time frame: Baseline, 3 months and 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 1 Jun 2022.