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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
Sponsor:
Information provided by (Responsible Party):
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.

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)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
Contact: CARCOPINO Xavier, PU-PH 04 91 96 46 72 xavier.carcopino-usoli@mail.ap-hm.fr

Locations
France
: Service de Gynécologie Obstétrique Hôpital Nord Recruiting
Marseille, Marseille Cedex 20, France, 13915
Contact: Xavier Carcopino, PU-PH    04 91 96 46 72    xavier.carcopino-usoli@mail.ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Jean Olivier Arnaud, Director Assistance Publique Hôpitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03837054     History of Changes
Other Study ID Numbers: 2018-63
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No