Clinical trial NCT04363190: Genomic Instability in Vascular Surgeons
Official title: Genomic Instability Associated With Chronic Long Term Exposure to Ionizing Radiation in Vascular Surgeons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cytogenetic Abnormality
Radiation Exposure
Keywords: Vascular surgery
Endovascular surgery
Lead sponsor: Hospital Clínico Universitario de Valladolid
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The differences between cases and controls regarding chromosomal numerical aberrations during interphase using FISH technique
timeFrame: 2 years
measure: The differences between cases and controls after G banding technique
timeFrame: 2 years
measure: The differences between cases and controls regarding the presence of SCE during metaphase.
timeFrame: 2 years
Secondary outcomes:
measure: Demographic variables, in terms of age and sex, regarding the presence of chromosomal aberrations and SCE.
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Hospital Clínico Universtario de Valladolid
state: Castilla Y León
Study officials:
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