Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
28 participants
OBSERVATIONAL
2018-11-09
2019-11-05
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Cases
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).
Controls
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
ALL
No
Sponsors
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Hospital Clínico Universitario de Valladolid
OTHER
Responsible Party
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Enrique M. San Norberto
MD, PhD, Chief of Unit
Locations
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Hospital Clínico Universtario de Valladolid
Valladolid, Castille and León, Spain
Countries
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References
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Mu H, Sun J, Li L, Yin J, Hu N, Zhao W, Ding D, Yi L. Ionizing radiation exposure: hazards, prevention, and biomarker screening. Environ Sci Pollut Res Int. 2018 Jun;25(16):15294-15306. doi: 10.1007/s11356-018-2097-9. Epub 2018 Apr 29.
Jaco JW, Miller DL. Measuring and monitoring radiation dose during fluoroscopically guided procedures. Tech Vasc Interv Radiol. 2010 Sep;13(3):188-93. doi: 10.1053/j.tvir.2010.03.009.
Balter S, Hopewell JW, Miller DL, Wagner LK, Zelefsky MJ. Fluoroscopically guided interventional procedures: a review of radiation effects on patients' skin and hair. Radiology. 2010 Feb;254(2):326-41. doi: 10.1148/radiol.2542082312.
Hertault A, Maurel B, Midulla M, Bordier C, Desponds L, Saeed Kilani M, Sobocinski J, Haulon S. Editor's Choice - Minimizing Radiation Exposure During Endovascular Procedures: Basic Knowledge, Literature Review, and Reporting Standards. Eur J Vasc Endovasc Surg. 2015 Jul;50(1):21-36. doi: 10.1016/j.ejvs.2015.01.014. Epub 2015 Mar 25.
Stecker MS, Balter S, Towbin RB, Miller DL, Vano E, Bartal G, Angle JF, Chao CP, Cohen AM, Dixon RG, Gross K, Hartnell GG, Schueler B, Statler JD, de Baere T, Cardella JF; SIR Safety and Health Committee; CIRSE Standards of Practice Committee. Guidelines for patient radiation dose management. J Vasc Interv Radiol. 2009 Jul;20(7 Suppl):S263-73. doi: 10.1016/j.jvir.2009.04.037. No abstract available.
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.
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.
Wilson DM 3rd, Thompson LH. Molecular mechanisms of sister-chromatid exchange. Mutat Res. 2007 Mar 1;616(1-2):11-23. doi: 10.1016/j.mrfmmm.2006.11.017. Epub 2006 Dec 6.
Miller DL, Vano E, Bartal G, Balter S, Dixon R, Padovani R, Schueler B, Cardella JF, de Baere T; Cardiovscular and Interventional Radiology Society of Europe; Society of Interventional Radiology. Occupational radiation protection in interventional radiology: a joint guideline of the Cardiovascular and Interventional Radiology Society of Europe and the Society of Interventional Radiology. Cardiovasc Intervent Radiol. 2010 Apr;33(2):230-9. doi: 10.1007/s00270-009-9756-7. Epub 2009 Dec 18. No abstract available.
The 2007 Recommendations of the International Commission on Radiological Protection. ICRP publication 103. Ann ICRP. 2007;37(2-4):1-332. doi: 10.1016/j.icrp.2007.10.003.
Boc V, Boc A, Zdesar U, Blinc A. Patients' radiation doses during percutaneous endovascular procedures in arteries of the lower limbs. Vasa. 2019 Mar;48(2):167-174. doi: 10.1024/0301-1526/a000744. Epub 2018 Oct 16.
Dendy PP. Radiation risks in interventional radiology. Br J Radiol. 2008 Jan;81(961):1-7. doi: 10.1259/bjr/15413265. Epub 2007 Nov 26.
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.
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: 10.1016/j.ejvs.2013.05.023. Epub 2013 Jul 19.
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.
Ingwersen M, Drabik A, Kulka U, Oestreicher U, Fricke S, Krankenberg H, Schwencke C, Mathey D. Physicians' radiation exposure in the catheterization lab: does the type of procedure matter? JACC Cardiovasc Interv. 2013 Oct;6(10):1095-102. doi: 10.1016/j.jcin.2013.05.012.
Majewska N, Blaszak MA, Juszkat R, Frankiewicz M, Makalowski M, Majewski W. Patients' radiation doses during the implantation of stents in carotid, renal, iliac, femoral and popliteal arteries. Eur J Vasc Endovasc Surg. 2011 Mar;41(3):372-7. doi: 10.1016/j.ejvs.2010.10.018. Epub 2010 Dec 13.
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.2015.11.019. Epub 2016 Feb 21.
Stanisic MG, Majewska N, Makalowski M, Juszkat R, Blaszak M, Majewski W. Patient radiation exposure during carotid artery stenting. Vascular. 2015 Apr;23(2):154-60. doi: 10.1177/1708538114540641. Epub 2014 Jun 25.
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. doi: 10.1080/08998280.2017.11929515.
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 Jan;37(1):396-403. doi: 10.1016/j.etap.2013.12.009. Epub 2013 Dec 31.
Lee WH, Nguyen PK, Fleischmann D, Wu JC. DNA damage-associated biomarkers in studying individual sensitivity to low-dose radiation from cardiovascular imaging. Eur Heart J. 2016 Oct 21;37(40):3075-3080. doi: 10.1093/eurheartj/ehw206. Epub 2016 Jun 5. No abstract available.
Rosolen DCB, Faria DK, Faria CS, Antonangelo L. Performance of the UroVysion(R) 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.
Other Identifiers
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PI-18-967
Identifier Type: -
Identifier Source: org_study_id
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