Does Chemotherapy Train the Mutation of the Pig-A Gene? (PIGA)
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|ClinicalTrials.gov Identifier: NCT03837054|
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : February 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Female||Biological: Blood collection and Micronuclei assay on binucleate lymphocytes in culture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does Chemotherapy Train the Mutation of the Pig-A Gene?|
|Actual Study Start Date :||January 10, 2019|
|Estimated Primary Completion Date :||January 10, 2021|
|Estimated Study Completion Date :||January 10, 2021|
|Breast cancer patients with external polychemotherapy||
Biological: Blood collection and Micronuclei assay on binucleate lymphocytes in culture
The activity of the oncology Department of the North Hospital ensures the quick and easy recruitment of 30 patients over the 10-month inclusion period. The collection of samples will be done in a forward-looking manner during chemotherapy and at different times. The patients will have 4 blood samples of 10 mL carried out during their chemotherapy with a sampling at T0 (before the initiation of chemotherapy), then to T1 (after the first 3 cures), to T2 (after the 6th cure) and to T3 is 5 weeks after the end of the chemo And before the onset of radiation therapy. The samples will be carried out within the Medical Oncology Department of the hospital Nord of Marseille.
We will also perform micronuclei testing on Binucleate lymphocytes in culture. The lymphocyte Micronuclei test reveals structure and number chromosomal damage and allows to reveal clastogenic or eugènes exposures.
- analysis of the frequency of reticulocytes PIG-A mutated [ Time Frame: 24 months ]
The analyzes will be applied at T0 to determine the intra-assay reproducibility. The frequency distributions of mutated cells will be compared:
- Between the two groups of patients at T0 then,
- Within each group between T0 (before exposure), T1 (in process), T2 (end of treatment) and T3 (in therapeutic monitoring post) using non-parametric tests on paired and unpaired.
- analysis of the binucleated cell micronuclei frequency in culture [ Time Frame: 24 months ]Determining the frequency of micronucleated binucleate cells in culture will be performed on the samples at T0 and T3 each patient of both groups. The frequency distribution of micronucleated cells will be compared within each group between T0 and T3 using non-parametric tests on paired series. A difference shall be considered significant if p <0.05.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837054
|Contact: CARCOPINO Xavier, PU-PH||04 91 96 46 firstname.lastname@example.org|
|: Service de Gynécologie Obstétrique Hôpital Nord||Recruiting|
|Marseille, Marseille Cedex 20, France, 13915|
|Contact: Xavier Carcopino, PU-PH 04 91 96 46 72 email@example.com|
|Study Director:||Jean Olivier Arnaud, Director||Assistance Publique Hôpitaux de Marseille|