Mycosis FungicidesKIRNCT00748319
Killer Immunoglobulin-Like Receptor Transcripts Expression for the Diagnosis of Epidermotropic Cutaneous T Cell Lymphoma
A study testing Detection of KIR receptor by RT PCR in people with Mycosis Fungicides and Sezary Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The most frequent cutaneous T-cell lymphomas (CTCL) are mycosis fungoid and Sezary syndrome. The diagnosis of these lymphomas is difficult using current methods, especially because numerous benign dermatological conditions can mimick CTCL both clinically and under microscopic examination. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Mycosis Fungicides, Sezary Syndrome, Dermatitis
- What is being tested?
- Detection of KIR receptor by RT PCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Dec 2011
- Phase
- Interventional
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed consent
- Subacute/chronic dermatitis (>7 days) with clinical suspicion for cutaneous T-cell lymphoma
- No past history of lymphoma or other hematologic malignancy
- Skin biopsy for routine histology at inclusion
- Cutaneous T-cell clonality analysis at inclusion
- Sezary cell count on routine blood smear examination in case of erythroderma
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- Blood T-cell clonality analysis at inclusion in case of erythroderma
- Age<18 years
- Skin biopsy for routine histology at inclusion (Possibility, in the 6 previous months of inclusion without any specific treatment other taht local corticoids- amendment n°4)
- Cutaneous T-cell clonality analysis at inclusion (Possibility, in the 6 previous months of inclusion without any specific treatment other taht local corticoids- amendment n°4)
- Realization of a preliminary medical examination
- Sezary cell count on routine blood smear examination in case of erythroderma (Possibility, in the 6 previous months of inclusion without any specific treatment other taht local corticoids- amendment n°4)
- Blood T-cell clonality analysis at inclusion in case of erythroderma (Possibility, in the 6 previous months of inclusion without any specific treatment other taht local corticoids- amendment n°4)
Who cannot join
- Adults under tutelage
- Subject not affiliated at the French National health and pensions organization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Killer Immunoglobulin-like Receptor Transcripts Expression for the Diagnosis of Epidermotropic Cutaneous T-cell Lymphomas (Mycosis Fungoid and Sézary Syndrome) in Patients With Erythroderma or Erythematous Patches/Plaques.
The most frequent cutaneous T-cell lymphomas (CTCL) are mycosis fungoid and Sezary syndrome. The diagnosis of these lymphomas is difficult using current methods, especially because numerous benign dermatological conditions can mimick CTCL both clinically and under microscopic examination. Recently, the KIR receptor CD158k has been shown to be a marker for Sezary syndrome in both the blood and skin. We hypothesize that other receptors from the same family may help fro the diagnosis of these lymphomas. To address this issue, we will study the expression of all known KIR receptor in the skin of patients presenting with a skin eruption, which may correspond to either a cutaneous T-cell lymphoma or a benign dermatological disease. The final diagnosis will be established by a panel of experts, allowing constitution of 2 groups of patients : the cutaneous T-cell lymphoma group, and the benign inflammatory disease group. The expression of the different KIRs will be analyzed in both group in a blinded fashion, in order to determine whether one or a several KIRs may be differentially expressed.
Read the detailed description
Background : The most frequent cutaneous T-cell lymphomas (CTCL) are mycosis fungoid and Sezary syndrome. Both are due to the proliferation of a CD4+ T-cell clone in the skin, associated with a blood involvement in Sezary syndrome. Mycosis fungoid clinically presents as a patches or plaques dermatitis and Sezary syndrome as an exfoliative dermatitis. The diagnosis of these lymphomas is difficult using current methods, especially because numerous benign dermatological inflammatory conditions can mimick CTCL both clinically and under microscopic examination. Recently, the KIR receptor CD158k has been shown to be a marker for Sezary syndrome in both the blood and skin. We hypothesize that other receptors from the same family may help fro the diagnosis of these lymphomas.
Aim of the study : to determine if one or a panel of KIR(s) receptor(s) may help for the differential diagnosis between cutaneous T-cell lymphoma (CTCL) and benign inflammatory dermatoses.
Subjects selection : all patients presenting to an investigator, member of the GFELC experts group ("French Group Study Cutaneous Lymphoma"), with either an exfoliative or patch/plaque dermatitis with a clinical suspicion of CTCL will be enrolled.
Number of subjects : A total of 550 patients could be recruited by the GFELC, including 180 CTCL (60 Sezary syndrome and 120 mycosis fungoid) and 370 inflammatory diseases (240 patch dermatitis and 130 exfoliative dermatitis).
Inclusion period : patients will be included during a 2 years period and will be followed during 6 months. Total study length will be 30 months.
Interventions : 1) 3 mm punch skin biopsy for all patients 2) 10 ml blood sample for patients with exfoliative dermatitis Methods : Following initial and 6 month follow-up evaluations, patients will be classified in one of the following groups : the cutaneous T-cell lymphoma group, and the benign inflammatory disease group. The expression of all known KIRs receptors (KIR2DL1 (CD158a), KIR2DL2 (CD158b1), KIR2DL3 (CD158b2), KIR2DL4 (CD158d), KIR2DL5 (CD158f), KIR3DL1 (CD158e1), KIR3DL2 (CD158k), KIR2DS1 (CD158h), KIR2DS2 (CD158j), KIR2DS4 (CD158i), KIR2DS5 (CD158g), KIR3DS1 (CD158e2)) will be evaluated using reverse transcription and quantitative polymerase chain reaction in all skin and blood samples, in a blinded fashion. For blood samples, the analyses will be performed on CD4+ T-cell sorted using magnetic beads.
Outcome measures : The main outcome measure will be the differential expression of one or a panel of KIR(s) receptor(s) between CTCL and benign inflammatory diseases. Secondary outcome measure will be a differential quantitative expression of one or a panel of KIR(s) receptor(s) between the two groups.
- Being tested
- Detection of KIR receptor by RT PCR
- Keywords
- Receptors KIR, Polymerase chain reaction, Diagnosis, Lymphoma T-cell cutaneous, Mycosis fungicides, Sezary syndrome, Differential diagnosis from dermatitis
- Medical subject headings
- Sezary Syndrome, Dermatitis, Dermatitis, Exfoliative, Disease, Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of KIR receptor by RT PCROther
Detection on biopsy cutaneous (3mm) and on blood sample of 30 ml
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Detection of KIR receptor Receives: Other: Detection of KIR receptor by RT PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential expression of one or a panel of KIRs transcript(s) between epidermotropic cutaneous lymphoma and inflammatory diseases
Measured: at the inclusion
Secondary outcomes (1)
Difference(s) in the quantitative expression of one or a panel of KIRs transcript(s) between epidermotropic cutaneous lymphoma and inflammatory diseases
Measured: at the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startMar 2009
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycosis FungicidesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Ortonne, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748319
- Sponsor's protocol ID
- P070153
- Acronym
- KIR
- Status last verified
- Aug 2012
- First submitted
- 5 Sep 2008
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Killer Immunoglobulin-like Receptor Transcripts Expression for the Diagnosis of Epidermotropic Cutaneous T-cell Lymphomas (Mycosis Fungoid and Sézary Syndrome) in Patients With Erythroderma or Erythematous Patches/Plaques.
- ClinicalTrials.gov ID
- NCT00748319
- Acronym / sponsor ID
- KIR / P070153
- Keywords
- Receptors KIR, Polymerase chain reaction, Diagnosis, Lymphoma T-cell cutaneous, Mycosis fungicides, Sezary syndrome, Differential diagnosis from dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 8 Sep 2008 (estimated)
- 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 most frequent cutaneous T-cell lymphomas (CTCL) are mycosis fungoid and Sezary syndrome. The diagnosis of these lymphomas is difficult using current methods, especially because numerous benign dermatological conditions can mimick CTCL both clinically and under microscopic examination. Recently, the KIR receptor CD158k has been shown to be a marker for Sezary syndrome in both the blood and skin. We hypothesize that other receptors from the same family may help fro the diagnosis of these lymphomas. To address this issue, we will study the expression of all known KIR receptor in the skin of patients presenting with a skin eruption, which may correspond to either a cutaneous T-cell lymphoma or a benign dermatological disease. The final diagnosis will be established by a panel of experts, allowing constitution of 2 groups of patients : the cutaneous T-cell lymphoma group, and the benign inflammatory disease group. The expression of the different KIRs will be analyzed in both group in a blinded fashion, in order to determine whether one or a several KIRs may be differentially expressed.
Detailed description
Background : The most frequent cutaneous T-cell lymphomas (CTCL) are mycosis fungoid and Sezary syndrome. Both are due to the proliferation of a CD4+ T-cell clone in the skin, associated with a blood involvement in Sezary syndrome. Mycosis fungoid clinically presents as a patches or plaques dermatitis and Sezary syndrome as an exfoliative dermatitis. The diagnosis of these lymphomas is difficult using current methods, especially because numerous benign dermatological inflammatory conditions can mimick CTCL both clinically and under microscopic examination. Recently, the KIR receptor CD158k has been shown to be a marker for Sezary syndrome in both the blood and skin. We hypothesize that other receptors from the same family may help fro the diagnosis of these lymphomas.
Aim of the study : to determine if one or a panel of KIR(s) receptor(s) may help for the differential diagnosis between cutaneous T-cell lymphoma (CTCL) and benign inflammatory dermatoses.
Subjects selection : all patients presenting to an investigator, member of the GFELC experts group ("French Group Study Cutaneous Lymphoma"), with either an exfoliative or patch/plaque dermatitis with a clinical suspicion of CTCL will be enrolled.
Number of subjects : A total of 550 patients could be recruited by the GFELC, including 180 CTCL (60 Sezary syndrome and 120 mycosis fungoid) and 370 inflammatory diseases (240 patch dermatitis and 130 exfoliative dermatitis).
Inclusion period : patients will be included during a 2 years period and will be followed during 6 months. Total study length will be 30 months.
Interventions : 1) 3 mm punch skin biopsy for all patients 2) 10 ml blood sample for patients with exfoliative dermatitis Methods : Following initial and 6 month follow-up evaluations, patients will be classified in one of the following groups : the cutaneous T-cell lymphoma group, and the benign inflammatory disease group. The expression of all known KIRs receptors (KIR2DL1 (CD158a), KIR2DL2 (CD158b1), KIR2DL3 (CD158b2), KIR2DL4 (CD158d), KIR2DL5 (CD158f), KIR3DL1 (CD158e1), KIR3DL2 (CD158k), KIR2DS1 (CD158h), KIR2DS2 (CD158j), KIR2DS4 (CD158i), KIR2DS5 (CD158g), KIR3DS1 (CD158e2)) will be evaluated using reverse transcription and quantitative polymerase chain reaction in all skin and blood samples, in a blinded fashion. For blood samples, the analyses will be performed on CD4+ T-cell sorted using magnetic beads.
Outcome measures : The main outcome measure will be the differential expression of one or a panel of KIR(s) receptor(s) between CTCL and benign inflammatory diseases. Secondary outcome measure will be a differential quantitative expression of one or a panel of KIR(s) receptor(s) between the two groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Detection of KIR receptor by RT PCRDetection of KIR receptor |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed consent
- Subacute/chronic dermatitis (>7 days) with clinical suspicion for cutaneous T-cell lymphoma
- No past history of lymphoma or other hematologic malignancy
- Skin biopsy for routine histology at inclusion
- Cutaneous T-cell clonality analysis at inclusion
Key exclusion criteria (2 listed)
- Adults under tutelage
- Subject not affiliated at the French National health and pensions organization
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 |
|---|---|---|
| Detection of KIR receptor by RT PCRDetection on biopsy cutaneous (3mm) and on blood sample of 30 ml | Other | 1 |
Primary outcome
Differential expression of one or a panel of KIRs transcript(s) between epidermotropic cutaneous lymphoma and inflammatory diseases
Time frame: at the inclusion
1 secondary outcome
Difference(s) in the quantitative expression of one or a panel of KIRs transcript(s) between epidermotropic cutaneous lymphoma and inflammatory diseases
Time frame: at the inclusion
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 22 Aug 2012.
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.
Nicolas Ortonne, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detection of KIR receptor by RT PCR in people with Mycosis Fungicides and Sezary Syndrome, run by Assistance Publique - Hôpitaux de Paris 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 13 inclusion and 2 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 22 Aug 2012. 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?
Differential expression of one or a panel of KIRs transcript(s) between epidermotropic cutaneous lymphoma and inflammatory diseases (time frame: at the inclusion). 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 22 Aug 2012.