AzTrials
AzTrials

Cytogenetic AbnormalityIRADIENTNCT04363190

Genomic Instability in Vascular Surgeons

An observational study of Cytogenetic Abnormality and Radiation Exposure, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cytogenetic Abnormality, Radiation Exposure
What is being tested?
Cytogenetic analysis
How many people
28 participants
Where
1 siteSpain
Study dates
9 Nov 2018to 5 Nov 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Clínico Universtario de Valladolid

    Valladolid, Castille and León, 47003

Other trials in Spain

About this study

Official title: Genomic Instability Associated With Chronic Long Term Exposure to Ionizing Radiation 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.

Being tested
Cytogenetic analysis
Keywords
Vascular surgery, Endovascular surgery
Medical subject headings
Chromosome Aberrations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cytogenetic analysisDiagnostic test

    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).
Study groups in NCT04363190
Study groupRoleWhat they receive
CasesNot described
Receives: Diagnostic Test: Cytogenetic analysis
ControlsNot described
Receives: Diagnostic Test: Cytogenetic analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

  2. The differences between cases and controls after G banding technique

    The differences between cases and controls regarding chromosomal numerical and structural aberrations during metaphase.

    Measured: 2 years

  3. 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.

    Measured: 2 years

Secondary outcomes (2)
  1. 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.

    Measured: 2 years

  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.

    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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2020
  2. Study start9 Nov 2018
  3. Primary completion20 Apr 2019
  4. Study completion5 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04363190
Sponsor's protocol ID
PI-18-967
Acronym
IRADIENT
Status last verified
Apr 2020
First submitted
23 Apr 2020
Last updated
27 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29705904
  • 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.

    PubMed 20723835
  • 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.

    PubMed 20093507
  • 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.

    PubMed 25818982
  • 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.

    PubMed 19560006
  • 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.

    PubMed 31232047
  • 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.

    PubMed 31267420
  • 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.

    PubMed 17157333
  • 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.

    PubMed 20020300
  • 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.

    PubMed 18082557
  • 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.

    PubMed 30322344
  • 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.

    PubMed 18039723
  • 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.

    PubMed 25476871
  • 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.

    PubMed 23871303
  • 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.

    PubMed 30028182

Questions about this trial

What is this clinical trial studying?

An observational study of Cytogenetic Abnormality and Radiation Exposure, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The differences between cases and controls regarding chromosomal numerical aberrations during interphase using FISH technique (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04363190, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in