Clinical Database of Safe Personalized Adjuvant Breast Radiotherapy Based on Individual Radiosensitivity
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- STATUS
- Recruiting
-
- participants needed
- 500
-
- sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
Summary
Severe but also moderate toxicities after curative-intent
In that context, a normal tissue radiosensitivity test that includes a rapid (72 h) radiosensitivity assay based on flow cytometric assessment of radiation-induced CD8 T-lymphocyte apoptosis (RILA) and other significant clinical parameters (multifactorial nomogram) was developed.
Omission of
Reduction of the breast irradiated volume is also a possibility that has been tested and
published using IORT,
Our hypothesis is therefore that the different techniques (volume reduction or
We would like to establish a prospective evaluation of daily practice including the individual radiosensitivity test to the decision of daily practice
Description
Severe but also moderate toxicities after curative-intent
In that context, a normal tissue radiosensitivity test that includes a rapid (72 h)
radiosensitivity assay based on flow cytometric assessment of radiation-induced CD8
T-lymphocyte apoptosis (RILA) and other significant clinical parameters (multifactorial
nomogram) was developed. The NovaGray Breast test combines both a biological analysis
(radio-induced lymphocyte apoptosis) and a predictive analysis, including external parameters
related to the patient and her treatment. A negative predictive value (>90%) was found in
case of high RILA taken alone and a
The NovaGray Breast test is now validated after two prospective trials, one French (PHRC)
and one European (Requite FP7). RILA and other factors have been confirmed to be independent
factors that increase significantly the appearance of severe
In the meantime, several treatment modifications have been suggested to reduce
Omission of
Reduction of the breast irradiated volume is also a possibility that has been tested and
published using IORT,
Details
Condition |
|
---|---|
Age | 65years - 100years |
Treatment |
|
Clinical Study Identifier | NCT04282122 |
Sponsor | Institut du |
Last Modified on | 19 February 2024 |
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