Cutaneous T-Cell LymphomaNCT06382844
Novel Flow-cytometry Approaches to Improve the Detection of Tumor Cells in CTCL
An observational study of Cutaneous T-Cell Lymphoma, run by Instituto de Investigación Biomédica de Salamanca at 1 site in Spain.
Trial summary
Identification and quantitation of circulating tumor cells in patients with cutaneous T-cell lymphoma -mycosis fungoides (MF)/Sézary syndrome (SS)- are required for diagnosis and precising the actual staging and response to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T-Cell Lymphoma
- What is being tested?
- Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS).
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Observational
- 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
Study population: Cases of cutaneous lymphoma/reactive erythroderma will be recruited from the routine clinical practice of the Cutaneous T-Cell Lymphoma Monographic Clinic at the University Hospital of Salamanca, which is conducted in a multidisciplinary manner under the responsibility of the Dermatology and Hematology services, involving two members of the research team (ECA and MLP). Diagnosis will be made according to the current criteria of the EORTC-OMS; patients will be included both at diagnosis and at any other stage of the tumor during follow-up
Who may be able to join
- Patients with cutaneous T-cell lymphoma
- Over 18 years old
- Sign the informed consent
Who cannot join
- Under 18 years old
- Do not sign the informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Instituto de Investigación Biomédica de Salamanca (IBSAL)
Salamanca, 37007
Ricardo López Pérez, PhD, +34 923 29 12 00 ext. 55144, uicec.gestion@ibsal.es
Esperanza López Franco, PhD, +34 923 29 12 00 ext. 55779, uicec.coordinacion@ibsal.es
About this study
Official title: Design, Development, and Validation of Novel "Next Generation Flow" Approaches for Rapid, Specific, Sensitive, and Reproducible Detection of Tumor Cells in Cutaneous T-cell Lymphoma.
Identification and quantitation of circulating tumor cells in patients with cutaneous T-cell lymphoma -mycosis fungoides (MF)/Sézary syndrome (SS)- are required for diagnosis and precising the actual staging and response to treatment. The current flow cytometry techniques used in clinical laboratories do not correctly allow to compare results in a clinical setting. Furthermore, now we know that the phenotype of tumor cells partially overlaps with that of normal TCD4+ cells, and it is rather heterogeneous. The GENERAL OBJECTIVE of this project is to apply flow-cytometry standardized strategies for rapid, specific, sensitive, and reproducible detection and quantitation of tumor cells in patients with MF/SS. For this purpose, in the first phase of the project we will design an optimal combination of markers to detect tumor cells by spectral flow-cytometry, and then the specificity and analytical sensitivity of the new combination/procedure will be assessed in blood samples -to be later applied to skin samples-, and finally reference databases will be created for the automatic analysis of cytometry data. In a second phase of the project, the developed method will be validated in a multicenter manner, through the demonstration of its practical applicability and clinical utility (speed and precision) in blood samples (and skin, where appropriate) for diagnosis, staging, and treatment monitoring. In parallel, the tumor microenvironment (residual normal immune system) will be explored -by applying the panel designed in the first phase together with additional immune-monitoring panels by flow cytometry-, and its relationship with clinical-biological heterogeneity of the tumor will be analyzed. In the two phases of the project, cytometry data will be compared with the gold standard approach to identify tumor T cells (through the identification of clonal rearrangement by PCR and/or NGS, performed on cell populations previously sorted by flow cytometry).
Read the detailed description
Primary cutaneous lymphomas are a group of tumors derived from lymphocytes (mostly T lymphocytes) that primarily affect the skin (such as mycosis fungoides, MF), although they can spread beyond the skin in more advanced stages - for example, to the blood - or may already be disseminated initially, as is the case with Sézary syndrome (SS), a tumor with very aggressive behavior from the beginning, which by definition already has blood dissemination at diagnosis. They are very rare tumors and difficult to diagnose because often the skin lesions are indistinguishable from benign processes (the latter much more common than cutaneous lymphomas). For this reason, it is not uncommon for the diagnosis to be delayed, with the consequent negative impact on the patient's prognosis if it is a tumor. Currently, the diagnosis of blood dissemination (the amount of which is also essential because it impacts the prognosis, the worse the higher tumor burden in the blood) is performed by flow cytometry, which has replaced conventional morphology. However, the flow cytometry techniques currently used in most clinical laboratories are not standardized among different centers, and therefore the comparability of the results (even over time, in the same center) and their use in the clinical settings is difficult.
In this project, the investigators HYPOTHESIZE that the application of novel "next-generation flow" strategies proposed by the international collaborative group EuroFlow (to which the applicant of this proposal belongs) would improve the detection of circulating tumor cells in patients with cutaneous T-cell lymphoma, which would allow improving the clinical management of the patients. Therefore, in this project, the aim as a GENERAL OBJECTIVE to apply standardized strategies of next-generation flow cytometry developed by the EuroFlow Consortium for the rapid, specific, sensitive, and reproducible detection and quantification of tumor cells in patients with MF/SS, through: i) the application of standardized sample staining procedures with antibody panels designed after previous rounds of testing, which would allow distinguishing tumor T lymphocytes from normal T cells (specificity); ii) adapting the technique to analyze a large number of cells, in order to achieve a high sensitivity of detection, also crucial for a more precise monitoring of residual disease in blood after treatment with the new therapies available in cutaneous T-cell lymphomas; and iii) development of automatic analysis strategies of cytometry data, so that the results do not depend on the personal experience of the cytometrist.
IMPACT. The availability of a new standardized flow cytometry strategy for sensitive and specific detection (and quantification) of circulating tumor cells in blood (and skin) of patients with cutaneous T-cell lymphoma will provide an essential tool to support dermo-hematological diagnosis, with the possibility of translating to routine diagnosis in the very short term after the completion of the project, for its application in hospitals that have a Cytometry/Immunopathology Laboratory, with the aim of: i) Making an early and accurate (differential) diagnosis between lymphoma - benign lesion in patients with skin lesions; ii) Detecting tumor cells in blood with greater sensitivity than conventional methods, to more precisely establish blood dissemination of a primary cutaneous T-cell lymphoma, and to assess the response to current treatments in a more reliable and sensitive way
- Conditions
- Cutaneous T-Cell Lymphoma
- Being tested
- Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS).
- Keywords
- Lymphoma, T Cell, Cutaneous, Flow cytometry, Mycosis fungoides, Sézary syndrome
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Lymphoma, Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS).Diagnostic test
Specific, sensitive, and reproducible (blood) detection and quantitation of tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS)
| Study group | Role | What they receive |
|---|---|---|
| Cutaneous T-cell lymphoma | Patients with cutaneous T-cell lymphoma Receives: Diagnostic Test: Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS). | |
| Control group 1 | patients with benign/reactive erythroderma Receives: Diagnostic Test: Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS). | |
| Control group 2 | patients with systemic inflammatory processes regardless of whether they have cutaneous involvement Receives: Diagnostic Test: Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS). | |
| Control group 3 | healthy adult subjects, age- and sex-matched with patients Receives: Diagnostic Test: Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimizing Marker Combination for Specific Identification and Quantification of Sézary Cells using Spectral Flow Cytometry
Designing an optimal marker combination for the specific identification and quantification of Sézary cells (particularly in blood) using spectral flow cytometry, enabling their discrimination from normal/reactive TCD4+ cells, and including markers for T-cell identification, T-cell maturation, aberrant markers, and markers to assess T-cell clonality
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Jan 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T-Cell LymphomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Biomédica de Salamanca
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute
- Responsible party
- Sponsor
- Investigators
- Julia M Almeida Parra, Prof., Principal investigator, Instituto de Investigación Biomédica de Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382844
- Sponsor's protocol ID
- PI23/00486
- Other IDs
- PI2023 08 1416
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design, Development, and Validation of Novel "Next Generation Flow" Approaches for Rapid, Specific, Sensitive, and Reproducible Detection of Tumor Cells in Cutaneous T-cell Lymphoma.
- ClinicalTrials.gov ID
- NCT06382844
- Acronym / sponsor ID
- PI23/00486
- Conditions
- Cutaneous T-Cell Lymphoma
- Keywords
- Lymphoma, T Cell, Cutaneous, Flow cytometry, Mycosis fungoides, Sézary syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Instituto de Investigación Biomédica de SalamancaUniversity, hospital or other
- Collaborators
- Carlos III Health Institute
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Apr 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.
Identification and quantitation of circulating tumor cells in patients with cutaneous T-cell lymphoma -mycosis fungoides (MF)/Sézary syndrome (SS)- are required for diagnosis and precising the actual staging and response to treatment. The current flow cytometry techniques used in clinical laboratories do not correctly allow to compare results in a clinical setting. Furthermore, now we know that the phenotype of tumor cells partially overlaps with that of normal TCD4+ cells, and it is rather heterogeneous. The GENERAL OBJECTIVE of this project is to apply flow-cytometry standardized strategies for rapid, specific, sensitive, and reproducible detection and quantitation of tumor cells in patients with MF/SS. For this purpose, in the first phase of the project we will design an optimal combination of markers to detect tumor cells by spectral flow-cytometry, and then the specificity and analytical sensitivity of the new combination/procedure will be assessed in blood samples -to be later applied to skin samples-, and finally reference databases will be created for the automatic analysis of cytometry data. In a second phase of the project, the developed method will be validated in a multicenter manner, through the demonstration of its practical applicability and clinical utility (speed and precision) in blood samples (and skin, where appropriate) for diagnosis, staging, and treatment monitoring. In parallel, the tumor microenvironment (residual normal immune system) will be explored -by applying the panel designed in the first phase together with additional immune-monitoring panels by flow cytometry-, and its relationship with clinical-biological heterogeneity of the tumor will be analyzed. In the two phases of the project, cytometry data will be compared with the gold standard approach to identify tumor T cells (through the identification of clonal rearrangement by PCR and/or NGS, performed on cell populations previously sorted by flow cytometry).
Detailed description
Primary cutaneous lymphomas are a group of tumors derived from lymphocytes (mostly T lymphocytes) that primarily affect the skin (such as mycosis fungoides, MF), although they can spread beyond the skin in more advanced stages - for example, to the blood - or may already be disseminated initially, as is the case with Sézary syndrome (SS), a tumor with very aggressive behavior from the beginning, which by definition already has blood dissemination at diagnosis. They are very rare tumors and difficult to diagnose because often the skin lesions are indistinguishable from benign processes (the latter much more common than cutaneous lymphomas). For this reason, it is not uncommon for the diagnosis to be delayed, with the consequent negative impact on the patient's prognosis if it is a tumor. Currently, the diagnosis of blood dissemination (the amount of which is also essential because it impacts the prognosis, the worse the higher tumor burden in the blood) is performed by flow cytometry, which has replaced conventional morphology. However, the flow cytometry techniques currently used in most clinical laboratories are not standardized among different centers, and therefore the comparability of the results (even over time, in the same center) and their use in the clinical settings is difficult.
In this project, the investigators HYPOTHESIZE that the application of novel "next-generation flow" strategies proposed by the international collaborative group EuroFlow (to which the applicant of this proposal belongs) would improve the detection of circulating tumor cells in patients with cutaneous T-cell lymphoma, which would allow improving the clinical management of the patients. Therefore, in this project, the aim as a GENERAL OBJECTIVE to apply standardized strategies of next-generation flow cytometry developed by the EuroFlow Consortium for the rapid, specific, sensitive, and reproducible detection and quantification of tumor cells in patients with MF/SS, through: i) the application of standardized sample staining procedures with antibody panels designed after previous rounds of testing, which would allow distinguishing tumor T lymphocytes from normal T cells (specificity); ii) adapting the technique to analyze a large number of cells, in order to achieve a high sensitivity of detection, also crucial for a more precise monitoring of residual disease in blood after treatment with the new therapies available in cutaneous T-cell lymphomas; and iii) development of automatic analysis strategies of cytometry data, so that the results do not depend on the personal experience of the cytometrist.
IMPACT. The availability of a new standardized flow cytometry strategy for sensitive and specific detection (and quantification) of circulating tumor cells in blood (and skin) of patients with cutaneous T-cell lymphoma will provide an essential tool to support dermo-hematological diagnosis, with the possibility of translating to routine diagnosis in the very short term after the completion of the project, for its application in hospitals that have a Cytometry/Immunopathology Laboratory, with the aim of: i) Making an early and accurate (differential) diagnosis between lymphoma - benign lesion in patients with skin lesions; ii) Detecting tumor cells in blood with greater sensitivity than conventional methods, to more precisely establish blood dissemination of a primary cutaneous T-cell lymphoma, and to assess the response to current treatments in a more reliable and sensitive way
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cutaneous T-cell lymphoma | – | Diagnostic Test: Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS).Patients with cutaneous T-cell lymphoma |
| Control group 1 | – | Diagnostic Test: Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS).patients with benign/reactive erythroderma |
| Control group 2 | – | Diagnostic Test: Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS).patients with systemic inflammatory processes regardless of whether they have cutaneous involvement |
| Control group 3 | – | Diagnostic Test: Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS).healthy adult subjects, age- and sex-matched with patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases of cutaneous lymphoma/reactive erythroderma will be recruited from the routine clinical practice of the Cutaneous T-Cell Lymphoma Monographic Clinic at the University Hospital of Salamanca, which is conducted in a multidisciplinary manner under the responsibility of the Dermatology and Hematology services, involving two members of the research team (ECA and MLP). Diagnosis will be made according to the current criteria of the EORTC-OMS; patients will be included both at diagnosis and at any other stage of the tumor during follow-up
Key inclusion criteria (3 listed)
- Patients with cutaneous T-cell lymphoma
- Over 18 years old
- Sign the informed consent
Key exclusion criteria (2 listed)
- Under 18 years old
- Do not sign the informed consent
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 and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS).Specific, sensitive, and reproducible (blood) detection and quantitation of tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS) | Diagnostic test | Control group 1, Control group 2, Control group 3, Cutaneous T-cell lymphoma |
Primary outcome
Optimizing Marker Combination for Specific Identification and Quantification of Sézary Cells using Spectral Flow Cytometry
Time frame: 18 months
Designing an optimal marker combination for the specific identification and quantification of Sézary cells (particularly in blood) using spectral flow cytometry, enabling their discrimination from normal/reactive TCD4+ cells, and including markers for T-cell identification, T-cell maturation, aberrant markers, and markers to assess T-cell clonality
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 1 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Julia M Almeida Parra, Prof. principal investigator
Instituto de Investigación Biomédica de Salamanca
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 Cutaneous T-Cell Lymphoma, run by Instituto de Investigación Biomédica de Salamanca at 1 site in Spain.
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 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: looking for participants now, as of the sponsor's last update on 1 May 2025. 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 Spain. 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 Julia M Almeida Parra, Prof. (+34 923 29 45 00 ext. 5813, jalmeida@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimizing Marker Combination for Specific Identification and Quantification of Sézary Cells using Spectral Flow Cytometry (time frame: 18 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 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.