Genomic Instability in Vascular Surgeons

Radiation Exposure Clinical Trial

— IRADIENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04363190
• Other study ID #: PI-18-967
• Status: Completed
• Start date: November 9, 2018
• Est. completion date: November 5, 2019

Study information

• Verified date: April 2020
• Source: Hospital Clínico Universitario de Valladolid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 5, 2019
• Est. primary completion date: April 20, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chromosome Aberrations
• Chromosome Disorders
• Cytogenetic Abnormality
• Radiation Exposure

Intervention

Diagnostic Test:
• Cytogenetic analysis
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).

Locations

Country	Name	City	State
Spain	Hospital Clínico Universtario de Valladolid	Valladolid	Castilla Y León

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clínico Universitario de Valladolid

Country where clinical trial is conducted

Spain, 

References & Publications (23)

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Kostova-Lefterova DD, Nikolov NN, Stanev SS, Stoyanova BB. Patient doses in endovascular and hybrid revascularization of the lower extremities. Br J Radiol. 2018 Nov;91(1091):20180176. doi: 10.1259/bjr.20180176. Epub 2018 Aug 13. — View Citation

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Neill M, Charles HW, Pflager D, Deipolyi AR. Factors associated with reduced radiation exposure, cost, and technical difficulty of inferior vena cava filter placement and retrieval. Proc (Bayl Univ Med Cent). 2017 Jan;30(1):21-25. — View Citation

Patel AP, Gallacher D, Dourado R, Lyons O, Smith A, Zayed H, Waltham M, Sabharwal T, Bell R, Carrell T, Taylor P, Modarai B. Occupational radiation exposure during endovascular aortic procedures. Eur J Vasc Endovasc Surg. 2013 Oct;46(4):424-30. doi: 10.10 — View Citation

Rosolen DCB, Faria DK, Faria CS, Antonangelo L. Performance of the UroVysion(®) FISH assay for the diagnosis of malignant effusions using two cutoff strategies. Cancer Med. 2018 May;7(5):1967-1977. doi: 10.1002/cam4.1442. Epub 2018 Mar 25. — View Citation

Sailer AM, Schurink GW, Bol ME, de Haan MW, van Zwam WH, Wildberger JE, Jeukens CR. Occupational Radiation Exposure During Endovascular Aortic Repair. Cardiovasc Intervent Radiol. 2015 Aug;38(4):827-32. doi: 10.1007/s00270-014-1025-8. Epub 2014 Dec 5. — View Citation

Santovito A, Cervella P, Delpero M. Increased frequency of chromosomal aberrations and sister chromatid exchanges in peripheral lymphocytes of radiology technicians chronically exposed to low levels of ionizing radiations. Environ Toxicol Pharmacol. 2014 — View Citation

Sigterman TA, Bolt LJ, Snoeijs MG, Krasznai AG, Heijboer R, Schurink GW, Bouwman LH. Radiation Exposure during Percutaneous Transluminal Angioplasty for Symptomatic Peripheral Arterial Disease. Ann Vasc Surg. 2016 May;33:167-72. doi: 10.1016/j.avsg.2015.1 — View Citation

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Stecker MS, Balter S, Towbin RB, Miller DL, Vañó E, Bartal G, Angle JF, Chao CP, Cohen AM, Dixon RG, Gross K, Hartnell GG, Schueler B, Statler JD, de Baère T, Cardella JF; SIR Safety and Health Committee; CIRSE Standards of Practice Committee. Guidelines — View Citation

Sunada S, Haskins JS, Kato TA. Sister Chromatid Exchange as a Genotoxic Stress Marker. Methods Mol Biol. 2019;1984:61-68. doi: 10.1007/978-1-4939-9432-8_7. — View Citation

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Wdowiak A, Skrzypek M, Stec M, Panasiuk L. Effect of ionizing radiation on the male reproductive system. Ann Agric Environ Med. 2019 Jun 17;26(2):210-216. doi: 10.26444/aaem/106085. Epub 2019 May 6. Review. — View Citation

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The differences between cases and controls regarding chromosomal numerical aberrations during interphase using FISH technique	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
Primary	The differences between cases and controls after G banding technique	The differences between cases and controls regarding chromosomal numerical and structural aberrations during metaphase.	2 years
Primary	The differences between cases and controls regarding the presence of SCE during metaphase.	The differences between cases and controls regarding the presence of SCE during metaphase.	2 years
Secondary	Demographic variables, in terms of age and sex, regarding the presence of chromosomal aberrations and SCE.	Demographic variables, in terms of age and sex, regarding the presence of chromosomal aberrations and SCE.	2 years
Secondary	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.	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