Does Chemotherapy Train the Mutation of the Pig-A Gene? (PIGA)

Not Applicable

• Conditions: Breast Cancer Female
• Interventions: Biological: Blood collection and Micronuclei assay on binucleate lymphocytes in culture

• Registration Number: NCT03837054
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

The PIG-A gene (in humans)/Pig-a (in rodents) may be a useful reporter of acquired gene mutation. A simple and reproductive test based on flow cytometry allows detection of Pig-a mutants in a few minutes with low blood volumes. Many studies in rodents showed that detecting Pig-a mutations is useful for identifying genotoxic exposure, but studies are needed in humans to validate this biological marker. The investigators propose to carry out a study to assess the prevalence of PIG-A mutated reticulocytes among 30 patients exposed to genotoxic chemotherapy for breast cancer treatment. The investigators will prospectively collect, for each patient, 4 blood samples of 10mL during chemotherapy: the first one (T0) before chemotherapy (before genotoxic exposure), T1 during treatment (after the third cure), T2 (just at the end of chemotherapy) and T3 (five weeks after the end of chemotherapy). PIG-A mutated cells frequency distributions will be compared between T0, T1, T2 and T3. At the same time, the investigators will document the impact of such a genotoxic exposure using the micronuclei test on in vitro binucleate lymphocytes. The micronuclei test reveals structural or numerical chromosome aberrations caused by aneugenic or clastogenic exposure. This test will be done on T0 and T3 blood samples of each patient.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-10
• Study First Submitted: 2019-01-16
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-08
• Last Update Submitted: 2019-02-08
• Study First Posted: 2019-02-11
• Last Update Posted: 2019-02-11
• Primary Completion: 2021-01-10
• Study Completion: 2021-01-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Major patients
• Patients with breast cancer
• Who have benefited from breast surgical treatment and have a poly-chemotherapy adjuvanted by FEC100 and Docetaxel.
• Patients should be able to read and understand French.

Exclusion Criteria

• Minor Patients
• Pregnant women
• Patients who do not speak French and/or are unable to read and understand French.
• Patients who have had a history of radiotherapy, including those who have received a per-operative radiation therapy as part of the initial management of breast cancer
• Patients who have had a history of chemotherapy outside of the chemotherapy possibly received in the treatment of current breast cancer.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breast cancer patients with external polychemotherapy	Blood collection and Micronuclei assay on binucleate lymphocytes in culture	-

Primary Outcome Measures

Name	Time	Method
analysis of the frequency of reticulocytes PIG-A mutated	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	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.

Trial Locations

Locations (1)

: Service de Gynécologie Obstétrique Hôpital Nord; 🇫🇷 Marseille, Marseille Cedex 20, France