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Completed

NCT Number: NCT04363190

Genomic Instability 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico Universtario de Valladolid

Valladolid, Castille and León, 47003, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cytogenetic analysis

Diagnostic Test
  • 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.
  • G banding study to analyse the whole karyotype study regarding both numerical and structural aberrations during metaphase.
  • Sister chromatid exchanges (SCE) analysis with bromodeoxyuridine (BrdU) staining for the whole karyotype during metaphase: analizing the proportion of SCE per metaphase (NSM).

Primary outcomes

  1. 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. 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.

  3. 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.

Secondary outcomes

  1. 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. 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.

Sponsors and collaborators

Lead sponsor

Hospital Clínico Universitario de Valladolid

Other

Registry information

Official study title

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

Acronym: IRADIENT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 27, 2020
Registry last updated
Apr 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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