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Assessment of the Mutation of Pig-A Gene as Biomarker of Genotoxic Exposure in Humans (PIG-A)

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ClinicalTrials.gov Identifier: NCT02727868
Recruitment Status : Unknown
Verified March 2016 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date  ICMJE March 30, 2016
First Posted Date  ICMJE April 5, 2016
Last Update Posted Date April 5, 2016
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
  • analysis of the frequency of granulocytes 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Mutation of Pig-A Gene as Biomarker of Genotoxic Exposure in Humans
Official Title  ICMJE Assessment of the Mutation of Pig-A Gene as Biomarker of Genotoxic Exposure in Humans
Brief Summary

The evaluation of the impact of environment on the incidence of cancer is a major public health issue. Increased knowledge in this area is necessary for the implementation of primary prevention means with appropriate preventive measures but also to the implementation of secondary prevention measures with targeted screening actions.

Among the environmental exposures that may lead to cancer, mutagenic environments are of major importance, and the causal link between environmental genotoxicity and cancer has been established for a long time. It is also well established that susceptibility to mutation is highly variable among individuals. This is explained by genetic polymorphisms of genes involved in metabolism and in genome stability.

The identification of biomarkers of exposure to mutagenic environments is necessary for assessing the impact of an environment in humans. Some studies in animals have shown that the PIG-A gene may be a biomarker of exposure to a mutagenic environment. In particular, a significant increase in erythrocyte PIG-A mutants has been demonstrated in rats after a genotoxic exposure to cisplatin, but it has so far not been evaluated in humans. One study of healthy volunteers shows that the frequency of PIG-A mutated cells in humans can be estimated efficiently and reliably.

The PIG-A gene meets all the necessary criteria for a sentinel gene for tracking of spontaneous somatic mutation frequency or induced a mutagenic environment: ubiquitous expression, phenotypic change linked to a mono-allelic mutation viability of mutated cells , spectrum off inactivating mutations (deletions, substitutions, chromosomal rearrangements). Finally, the detection of the disappearance of glycosylphosphatidylinositol on the plasma membrane is easily achievable by flow cytometry.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Patient With Breast Cancer
Intervention  ICMJE Genetic: blood samples
Study Arms  ICMJE
  • exclusive breast irradiation group
    to assess the impact of irradiation areas
    Intervention: Genetic: blood samples
  • breast and sternal irradiation group
    to assess the impact of irradiation areas
    Intervention: Genetic: blood samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 30, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Major patients,
  • The patients achieving a breast cancer
  • Patients who have benefited from a breast surgery
  • Patients to have an external adjuvant radiotherapy.
  • Patients being able to read and understand French.
  • Patients beneficiaries of a social security scheme.
  • Pregnant women can not participate in this study. A pregnancy test should only be prescribed when clinically indicated, regardless of the course of the study.
  • Patients who received information and signed informed consent

Exclusion Criteria:

Patients who received chemotherapy before radiation therapy.

  • Minor patients
  • Patients who do not speak French and / or unable to read and understand French.
  • Patients who have had radiotherapy history
  • Patients who have had a history of chemotherapy
  • Patients who have not received the information and had not signed informed consent for participation
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02727868
Other Study ID Numbers  ICMJE 2015-42
2015-A01753-46 ( Registry Identifier: ID RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP