Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382844
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-20
Brief Title:
Novel Flow-cytometry Approaches to Improve the Detection of Tumor Cells in CTCL
Sponsor:
Instituto de Investigación Biomédica de Salamanca
Organization:
Instituto de Investigación Biomédica de Salamanca
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Identification and quantitation of circulating tumor cells in patients with cutaneous T-cell lymphoma -mycosis fungoides MFSézary 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 MFSS 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 combinationprocedure 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 andor 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 patients 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 MFSS 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 CytometryImmunopathology 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
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 MFSS 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 CytometryImmunopathology 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PI2023 08 1416 | REGISTRY | Ethics Committee for Drug Research of the Salamanca Health Area | None |