Genomic Instability in Vascular Surgeons (IRADIENT)

April 23, 2020 updated by: Enrique M. San Norberto, Hospital Clínico Universitario de Valladolid

Genomic Instability Associated With Chronic Long Term Exposure to Ionizing Radiation in Vascular Surgeons

The past two decades have witnessed the development and growth of the endovascular techniques, however, this new technology is not exempt from risks, since its use requires an ionizing radiation exposure to both patients and surgeons. In this context, the long-term repercussion of this type of chronic exposure to low dose ionizing radiation of the vascular surgeons is still unknown. Although conventional dosimetry is used to monitoring the occupational radiation exposure, it doesn't take into consideration a number of individual variables such as: age, sex, exposure to other carcinogen substances or previous medical history; that may affect the radio-sensibility of each individual. Some studies suggest the use of routine cytogenetic analysis to complement the conventional dosimetry, yet the real genomic effects of chronic low dose ionizing radiation exposure is still unclear and an ideal biodosimetry marker hasn't been described. In this setting, the main objective of the present study was to determine the genomic instability associated to the chronic low dose exposure to ionizing radiation of vascular surgeons versus healthy control patients with no history of radiation exposure.

The secondary endpoints were to determine the impact of demographic and clinical practice activities associated to genomic instability among both groups of patients.

National, observational and transversal case control study of genomic instability among vascular surgeons chronically exposed to low dose ionizing radiation compared to healthy control patients with no previous history of radiation exposure. The peripheral blood samples of the case group were collected from vascular surgeons during the VI International Symposium of Endovascular Surgery. The blood samples were followed by a demographic and endovascular practice questionnaire. On the other hand, the samples for the control group were collected from healthy patients undergoing saphenectomy and/or phlebectomy in our department at Hospital Clínico Universitario de Valladolid. All blood samples were send to the Cancer Investigation Center at Salamanca University where three types of genomic analysis were performed: (1) fluorescence in situ hybridization (FISH) study in interphase for the chromosomes 3, 7 and 17 and locus 9p21; (2) metaphase study with G banding technique; and (3) sister chromatid exchange (SCE) metaphase study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Castilla Y León
      • Valladolid, Castilla Y León, Spain, 47003
        • Hospital Clínico Universtario de Valladolid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The peripheral blood samples of the case group were collected from vascular surgeons during the VI International Symposium of Endovascular Surgery. The blood samples were followed by a demographic and endovascular practice questionnaire. On the other hand, the samples for the control group were collected from healthy patients undergoing saphenectomy and/or phlebectomy in our department at Hospital Clínico Universitario de Valladolid.

Description

Inclusion Criteria:

Cases

  • Vascular surgeons regularly involved in endovascular procedures.
  • Over 10 years of endovascular experience.
  • Accept to participate in the present study.

Controls:

  • Healthy patients undergoing saphenectomy and/or phlebectomy.
  • Accept to participate in the present study.

Exclusion Criteria:

Cases:

  • Less than 10-year endovascular experience.
  • Previous medical history of cancer.
  • Have been treated with radiotherapy.
  • Have been exposed to ionizing radiation outside the endovascular field.
  • Not accept to participate in the present study.

Controls:

  • Previous medical history of cancer.
  • Have been treated with radiotherapy.
  • Have been exposed to ionizing radiation.
  • Not accept to participate in the present study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Controls
Diagnostic test: Cytogenetic analysis
  1. FISH study using the UroVysion kit in interphase peripheral lymphocytes, that allows the study of numerical aberrations for chromosomes 3, 7 and 17 and locus 9p21.
  2. G banding study to analyse the whole karyotype study regarding both numerical and structural aberrations during metaphase.
  3. Sister chromatid exchanges (SCE) analysis with bromodeoxyuridine (BrdU) staining for the whole karyotype during metaphase: analizing the proportion of SCE per metaphase (NSM).
Cases
Diagnostic test: Cytogenetic analysis
  1. FISH study using the UroVysion kit in interphase peripheral lymphocytes, that allows the study of numerical aberrations for chromosomes 3, 7 and 17 and locus 9p21.
  2. G banding study to analyse the whole karyotype study regarding both numerical and structural aberrations during metaphase.
  3. Sister chromatid exchanges (SCE) analysis with bromodeoxyuridine (BrdU) staining for the whole karyotype during metaphase: analizing the proportion of SCE per metaphase (NSM).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The differences between cases and controls regarding chromosomal numerical aberrations during interphase using FISH technique
Time Frame: 2 years

The differences between cases and controls regarding chromosomal numerical aberrations during interphase of chromosomes 3, 7, 17 and locus 9p21.

The differences between cases and controls regarding chromosomal numerical aberrations during interphase using FISH technique with the UroVysion kit for chromosomes 3, 7, 17 and locus 9p21.
2 years
The differences between cases and controls after G banding technique
Time Frame: 2 years
The differences between cases and controls regarding chromosomal numerical and structural aberrations during metaphase.
2 years
The differences between cases and controls regarding the presence of SCE during metaphase.
Time Frame: 2 years
The differences between cases and controls regarding the presence of SCE during metaphase.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic variables, in terms of age and sex, regarding the presence of chromosomal aberrations and SCE.
Time Frame: 2 years
Demographic variables, in terms of age and sex, regarding the presence of chromosomal aberrations and SCE.
2 years
The impact of the anatomical region treated as well as the performance of complex aortic endovascular procedures amongst the group of vascular surgeons included in the present study regarding the presence of chromosomal aberrations and SCE.
Time Frame: 2 years
The impact of the anatomical region treated as well as the performance of complex aortic endovascular procedures amongst the group of vascular surgeons included in the present study regarding the presence of chromosomal aberrations and SCE.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clínico Universitario de Valladolid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 9, 2018

Primary Completion (ACTUAL)

April 20, 2019

Study Completion (ACTUAL)

November 5, 2019

Study Registration Dates

First Submitted

April 23, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (ACTUAL)

April 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-18-967

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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