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Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

BACKGROUND: To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. METHODS: The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials usin...

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Autores principales: Cihoric, Nikola, Tsikkinis, Alexandros, Miguelez, Cristina Gutierrez, Strnad, Vratislav, Soldatovic, Ivan, Ghadjar, Pirus, Jeremic, Branislav, Dal Pra, Alan, Aebersold, Daniel M., Lössl, Kristina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4804566/
https://www.ncbi.nlm.nih.gov/pubmed/27005770
http://dx.doi.org/10.1186/s13014-016-0624-8
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author Cihoric, Nikola
Tsikkinis, Alexandros
Miguelez, Cristina Gutierrez
Strnad, Vratislav
Soldatovic, Ivan
Ghadjar, Pirus
Jeremic, Branislav
Dal Pra, Alan
Aebersold, Daniel M.
Lössl, Kristina
author_facet Cihoric, Nikola
Tsikkinis, Alexandros
Miguelez, Cristina Gutierrez
Strnad, Vratislav
Soldatovic, Ivan
Ghadjar, Pirus
Jeremic, Branislav
Dal Pra, Alan
Aebersold, Daniel M.
Lössl, Kristina
author_sort Cihoric, Nikola
collection PubMed
description BACKGROUND: To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. METHODS: The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. RESULTS: In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). CONCLUSION: Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users.
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spelling pubmed-48045662016-03-24 Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database Cihoric, Nikola Tsikkinis, Alexandros Miguelez, Cristina Gutierrez Strnad, Vratislav Soldatovic, Ivan Ghadjar, Pirus Jeremic, Branislav Dal Pra, Alan Aebersold, Daniel M. Lössl, Kristina Radiat Oncol Research BACKGROUND: To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. METHODS: The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. RESULTS: In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). CONCLUSION: Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users. BioMed Central 2016-03-22 /pmc/articles/PMC4804566/ /pubmed/27005770 http://dx.doi.org/10.1186/s13014-016-0624-8 Text en © Cihoric et al. 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Cihoric, Nikola
Tsikkinis, Alexandros
Miguelez, Cristina Gutierrez
Strnad, Vratislav
Soldatovic, Ivan
Ghadjar, Pirus
Jeremic, Branislav
Dal Pra, Alan
Aebersold, Daniel M.
Lössl, Kristina
Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database
title Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database
title_full Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database
title_fullStr Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database
title_full_unstemmed Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database
title_short Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database
title_sort portfolio of prospective clinical trials including brachytherapy: an analysis of the clinicaltrials.gov database
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4804566/
https://www.ncbi.nlm.nih.gov/pubmed/27005770
http://dx.doi.org/10.1186/s13014-016-0624-8
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