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

NCT ID: NCT03837054

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-10
• Study Completion Date: 2021-01-10

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Breast cancer patients with external polychemotherapy

Group Type: OTHER

Blood collection and Micronuclei assay on binucleate lymphocytes in culture

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Olivier Arnaud, Director

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

: Service de Gynécologie Obstétrique Hôpital Nord

Marseille, Marseille Cedex 20, France

Site Status: RECRUITING

Countries

France

Central Contacts

CARCOPINO Xavier, PU-PH

Role: CONTACT

xavier.carcopino-usoli@mail.ap-hm.fr

04 91 96 46 72

Facility Contacts

Xavier Carcopino, PU-PH

Role: primary

xavier.carcopino-usoli@mail.ap-hm.fr

04 91 96 46 72

Other Identifiers

2018-63

Identifier Type: -

Identifier Source: org_study_id