CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Cytogenetic analysisother
Likely dose
Not stated in record
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Search/NCT04363190
NCT04363190N/ACompleted

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

Hospital Clínico Universitario de Valladolid·observational·Posted Apr 27, 2020·Updated Apr 27, 2020

In Brief

An observational study evaluating Cytogenetic analysis for Cytogenetic Abnormality and Radiation Exposure. Completed, enrolled 28 participants across 1 site.

Detailed Summary

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 Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 27, 2020
Enrollment StartNov 9, 2018
Primary CompletionApr 20, 2019
Study CompletionNov 5, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6.2 years ago

Interventions

Cytogenetic analysisother

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).