Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651203
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Evaluation of the KIR3DL2 Marker in Flow Cytometry for Sézary Syndrome Diagnosis Therapeutic Response and Residual Disease a Prospective and Multicenter Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the KIR3DL2 Marker in Flow Cytometry for Sézary Syndrome Diagnosis Therapeutic Response and Residual Disease a Prospective and Multicenter Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KISS01
Brief Summary:
Cutaneous T-cell lymphomas CTCL are a group of primary cutaneous lymphomas including Mycosis Fungoides MF and Sézary syndrome SS SS is characterized by erythroderma and high numbers of circulating atypical lymphocytes Sézary cells SCs Blood staging was added to the Tumor Node Metastasis TNM classification of MFSS reflecting the broad spectrum of CTCLs and the poor prognosis related to blood involvement Blood classes were defined using blood-smear manual counts However this method never reached an international consensus status because of its subjective nature and its poor sensitivity Several markers have been identified with variable efficiency for MFSS diagnosis outcome prediction and blood response to treatment Such markers are essential for sharing and publishing consistent data about diagnosis staging prognosis and response to therapies The detection of SCs is based on the lack of pan T-cell markers such as CD7 andor CD26 which is not constant and may be observed in benign dermatoses Thus patients are often diagnosed with a delay even treated with inappropriate therapies which worsens their prognosis The relevance of blood-class in MFSS is not only related to stage but also contributes to the response to therapy in clinical trials We found that a significant proportion of benign T-cells from SS patients are CD4CD26- which may underestimate the rate of complete response to treatment The identification of KIR3DL2 on SCs by our team has greatly helped the detailed study of the malignant clone We have recently published two ancillary studies demonstrating the specificity and reliability of KIR3DL2 as a positive marker for SCs and its prognosis value at initial diagnosis We have designed an optimized flow-cytometry strategy as part of the routine care of erythrodermic patients at Saint-Louis Hospital and published in 2019 the results of a 5 years prospective single-center study involving 254 CTCL patients at initial diagnosis We provided recommendations with the use a threshold value of KIR3DL2SCs 200µL or KIR3DL2SCslymphocytes 10 in the diagnostic criteria and proposed a novel algorithm blood staging
Several innovative immunotherapies in phase III trials or under compassionate use are ongoing in French centers with the need to assess blood response using positive markers Our goal is to validate KIR3DL2 as a specific marker for SS and to assess its reliability for blood staging and response to treatment in a multicenter study 11 centers
Several innovative immunotherapies in phase III trials or under compassionate use are ongoing in French centers with the need to assess blood response using positive markers Our goal is to validate KIR3DL2 as a specific marker for SS and to assess its reliability for blood staging and response to treatment in a multicenter study 11 centers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None