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

NCT03837054 | Unknown

• 1 other identifier: 2018-63
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (2)

• analysis of the frequency of reticulocytes PIG-A mutated

  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.

  24 months

• analysis of the binucleated cell micronuclei frequency in culture

  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.

  24 months

Study Arms (1)

Breast cancer patients with external polychemotherapy

OTHER

Biological: Blood collection and Micronuclei assay on binucleate lymphocytes in culture

Interventions

Blood collection and Micronuclei assay on binucleate lymphocytes in culture BIOLOGICAL

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.

Breast cancer patients with external polychemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

: Service de Gynécologie Obstétrique Hôpital Nord

Marseille, Marseille Cedex 20, 13915, France

RECRUITING

MeSH Terms

Interventions

Culture Techniques

Intervention Hierarchy (Ancestors)

In Vitro Techniques; Investigative Techniques

Study Officials

• Jean Olivier Arnaud, Director

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

CARCOPINO Xavier, PU-PH

CONTACT

04 91 96 46 72; xavier.carcopino-usoli@mail.ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: February 11, 2019
• Study Start: January 10, 2019
• Primary Completion: January 10, 2021
• Study Completion: January 10, 2021
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

FR (1)