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Diagnostic yield of colonoscopy surveillance in testicular cancer survivors treated with platinum-based chemotherapy: study protocol of a prospective cross-sectional cohort study

BACKGROUND: Testicular cancer (TC) survivors have an increased risk of various second primary malignancies. A recent cohort study detected an increased risk of colorectal cancer (CRC) in TC survivors treated with platinum-based chemotherapy with a hazard ratio of 3.9. CRC risk increased with higher...

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Autores principales: Ykema, Berbel L. M., Bisseling, Tanya M., Spaander, Manon C. W., Moons, Leon M. G., van der Biessen-van Beek, Dorien, Saveur, Lisette, Kerst, Martijn, Mulder, Sasja F., de Wit, Ronald, Zweers, Danielle, Meijer, Gerrit A., Beijnen, Jos H., Lansdorp-Vogelaar, Iris, van Leeuwen, Flora E., Snaebjornsson, Petur, van Leerdam, Monique E.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7881638/
https://www.ncbi.nlm.nih.gov/pubmed/33579196
http://dx.doi.org/10.1186/s12876-021-01639-2
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author Ykema, Berbel L. M.
Bisseling, Tanya M.
Spaander, Manon C. W.
Moons, Leon M. G.
van der Biessen-van Beek, Dorien
Saveur, Lisette
Kerst, Martijn
Mulder, Sasja F.
de Wit, Ronald
Zweers, Danielle
Meijer, Gerrit A.
Beijnen, Jos H.
Lansdorp-Vogelaar, Iris
van Leeuwen, Flora E.
Snaebjornsson, Petur
van Leerdam, Monique E.
author_facet Ykema, Berbel L. M.
Bisseling, Tanya M.
Spaander, Manon C. W.
Moons, Leon M. G.
van der Biessen-van Beek, Dorien
Saveur, Lisette
Kerst, Martijn
Mulder, Sasja F.
de Wit, Ronald
Zweers, Danielle
Meijer, Gerrit A.
Beijnen, Jos H.
Lansdorp-Vogelaar, Iris
van Leeuwen, Flora E.
Snaebjornsson, Petur
van Leerdam, Monique E.
author_sort Ykema, Berbel L. M.
collection PubMed
description BACKGROUND: Testicular cancer (TC) survivors have an increased risk of various second primary malignancies. A recent cohort study detected an increased risk of colorectal cancer (CRC) in TC survivors treated with platinum-based chemotherapy with a hazard ratio of 3.9. CRC risk increased with higher cisplatin-dose. We know that colonoscopy surveillance in high-risk populations results in reduced incidence and mortality of CRC. TC survivors treated with platinum-based chemotherapy can potentially benefit from colonoscopy surveillance; however, to which extent is unknown. Furthermore, the pathogenesis of these secondary CRCs is unknown, and better insights into the carcinogenesis may affect surveillance decisions. METHODS: This prospective multicenter study will be performed in four Dutch hospitals. TC survivors are eligible if treated with ≥ 3 cycles of cisplatin before age 50. Colonoscopy will be performed ≥ 8 years after initial treatment (minimum and maximum ages at colonoscopy, 35 and 75 years, respectively). The primary aim of the study is the diagnostic yield of advanced neoplasia detected during colonoscopy. As secondary aim, we will evaluate the molecular profile of advanced colorectal neoplasia and will assess current platinum levels in blood and urine and correlate blood-platinum levels with prevalence of colorectal lesions. Furthermore, we will investigate effectiveness of fecal immunochemical testing (FIT) and burden of colonoscopy by two questionnaires. Demographic data, previous history, results of colonoscopy, hemoglobin level of FIT and results of molecular and platinum levels will be obtained. Yield of colonoscopy will be determined by detection rate of adenoma and serrated lesions, advanced adenoma detection rate and CRC detection rate. The MISCAN model will be used for cost-effectiveness analyses of CRC surveillance. With 234 participants undergoing colonoscopy, we can detect an absolute difference of 6% of advanced neoplasia with 80% power. DISCUSSION: TC survivors treated with cisplatin-based chemotherapy can benefit from CRC surveillance. Evaluation of the diagnostic performance and patient acceptance of CRC surveillance is of importance to develop surveillance recommendations. Insight into the carcinogenesis of cisplatin-related advanced colorectal lesions will contribute to CRC prevention in the increasing number of TC survivors. The results may also be important for the many other cancer survivors treated with platinum-based chemotherapy. TRIAL REGISTRATION: Clinical Trials: NCT04180033, November 27, 2019, https://clinicaltrials.gov/ct2/show/NCT04180033.
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spelling pubmed-78816382021-02-17 Diagnostic yield of colonoscopy surveillance in testicular cancer survivors treated with platinum-based chemotherapy: study protocol of a prospective cross-sectional cohort study Ykema, Berbel L. M. Bisseling, Tanya M. Spaander, Manon C. W. Moons, Leon M. G. van der Biessen-van Beek, Dorien Saveur, Lisette Kerst, Martijn Mulder, Sasja F. de Wit, Ronald Zweers, Danielle Meijer, Gerrit A. Beijnen, Jos H. Lansdorp-Vogelaar, Iris van Leeuwen, Flora E. Snaebjornsson, Petur van Leerdam, Monique E. BMC Gastroenterol Study Protocol BACKGROUND: Testicular cancer (TC) survivors have an increased risk of various second primary malignancies. A recent cohort study detected an increased risk of colorectal cancer (CRC) in TC survivors treated with platinum-based chemotherapy with a hazard ratio of 3.9. CRC risk increased with higher cisplatin-dose. We know that colonoscopy surveillance in high-risk populations results in reduced incidence and mortality of CRC. TC survivors treated with platinum-based chemotherapy can potentially benefit from colonoscopy surveillance; however, to which extent is unknown. Furthermore, the pathogenesis of these secondary CRCs is unknown, and better insights into the carcinogenesis may affect surveillance decisions. METHODS: This prospective multicenter study will be performed in four Dutch hospitals. TC survivors are eligible if treated with ≥ 3 cycles of cisplatin before age 50. Colonoscopy will be performed ≥ 8 years after initial treatment (minimum and maximum ages at colonoscopy, 35 and 75 years, respectively). The primary aim of the study is the diagnostic yield of advanced neoplasia detected during colonoscopy. As secondary aim, we will evaluate the molecular profile of advanced colorectal neoplasia and will assess current platinum levels in blood and urine and correlate blood-platinum levels with prevalence of colorectal lesions. Furthermore, we will investigate effectiveness of fecal immunochemical testing (FIT) and burden of colonoscopy by two questionnaires. Demographic data, previous history, results of colonoscopy, hemoglobin level of FIT and results of molecular and platinum levels will be obtained. Yield of colonoscopy will be determined by detection rate of adenoma and serrated lesions, advanced adenoma detection rate and CRC detection rate. The MISCAN model will be used for cost-effectiveness analyses of CRC surveillance. With 234 participants undergoing colonoscopy, we can detect an absolute difference of 6% of advanced neoplasia with 80% power. DISCUSSION: TC survivors treated with cisplatin-based chemotherapy can benefit from CRC surveillance. Evaluation of the diagnostic performance and patient acceptance of CRC surveillance is of importance to develop surveillance recommendations. Insight into the carcinogenesis of cisplatin-related advanced colorectal lesions will contribute to CRC prevention in the increasing number of TC survivors. The results may also be important for the many other cancer survivors treated with platinum-based chemotherapy. TRIAL REGISTRATION: Clinical Trials: NCT04180033, November 27, 2019, https://clinicaltrials.gov/ct2/show/NCT04180033. BioMed Central 2021-02-12 /pmc/articles/PMC7881638/ /pubmed/33579196 http://dx.doi.org/10.1186/s12876-021-01639-2 Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data.
spellingShingle Study Protocol
Ykema, Berbel L. M.
Bisseling, Tanya M.
Spaander, Manon C. W.
Moons, Leon M. G.
van der Biessen-van Beek, Dorien
Saveur, Lisette
Kerst, Martijn
Mulder, Sasja F.
de Wit, Ronald
Zweers, Danielle
Meijer, Gerrit A.
Beijnen, Jos H.
Lansdorp-Vogelaar, Iris
van Leeuwen, Flora E.
Snaebjornsson, Petur
van Leerdam, Monique E.
Diagnostic yield of colonoscopy surveillance in testicular cancer survivors treated with platinum-based chemotherapy: study protocol of a prospective cross-sectional cohort study
title Diagnostic yield of colonoscopy surveillance in testicular cancer survivors treated with platinum-based chemotherapy: study protocol of a prospective cross-sectional cohort study
title_full Diagnostic yield of colonoscopy surveillance in testicular cancer survivors treated with platinum-based chemotherapy: study protocol of a prospective cross-sectional cohort study
title_fullStr Diagnostic yield of colonoscopy surveillance in testicular cancer survivors treated with platinum-based chemotherapy: study protocol of a prospective cross-sectional cohort study
title_full_unstemmed Diagnostic yield of colonoscopy surveillance in testicular cancer survivors treated with platinum-based chemotherapy: study protocol of a prospective cross-sectional cohort study
title_short Diagnostic yield of colonoscopy surveillance in testicular cancer survivors treated with platinum-based chemotherapy: study protocol of a prospective cross-sectional cohort study
title_sort diagnostic yield of colonoscopy surveillance in testicular cancer survivors treated with platinum-based chemotherapy: study protocol of a prospective cross-sectional cohort study
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7881638/
https://www.ncbi.nlm.nih.gov/pubmed/33579196
http://dx.doi.org/10.1186/s12876-021-01639-2
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