- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02727868
Assessment of the Mutation of Pig-A Gene as Biomarker of Genotoxic Exposure in Humans (PIG-A)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xavier CARCOPINO, PUPH
- Phone Number: 0491964672
- Email: xavier.carcopino-tusoli@ap-hm.fr
Study Locations
-
-
-
Marseille, France, 13354
- Assistance Publique Hopitaux de Marseille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: exclusive breast irradiation group
to assess the impact of irradiation areas
|
|
Other: breast and sternal irradiation group
to assess the impact of irradiation areas
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
24 months
|
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. |
24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2015-42
- 2015-A01753-46 (Registry Identifier: ID RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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