Protocol Outlines for Parts 1 and 2 of the Prospective Endoscopy III Study for the Early Detection of Colorectal Cancer: Validation of a Concept Based on Blood Biomarkers

Louise Rasmussen; Michael Wilhelmsen; Ib Jarle Christensen; Jens Andersen; Lars Nannestad Jørgensen; Morten Rasmussen; Jakob W. Hendel; Mogens R. Madsen; Jesper Vilandt; Thore Hillig; Michael Klærke; Anna-Marie Bloch Münster; Lars M. Andersen; Berit Andersen; Nete Hornung; Erland J. Erlandsen; Ali Khalid; phw435 phw435

doi:10.2196/resprot.6346

Protocol Outlines for Parts 1 and 2 of the Prospective Endoscopy III Study for the Early Detection of Colorectal Cancer: Validation of a Concept Based on Blood Biomarkers

Louise Rasmussen, Michael Wilhelmsen, Ib Jarle Christensen, Jens Andersen, Lars Nannestad Jørgensen, Morten Rasmussen, Jakob W. Hendel, Mogens R. Madsen, Jesper Vilandt, Thore Hillig, Michael Klærke, Anna-Marie Bloch Münster, Lars M. Andersen, Berit Andersen, Nete Hornung, Erland J. Erlandsen, Ali Khalid, phw435 phw435

Abstract

BACKGROUND: Programs for population screening of colorectal cancer (CRC) have been implemented in several countries with fecal immunochemical testing (FIT) as the preferred platform. However, the major obstacle for a feces-based testing method is the limited compliance that reduces the clinical sensitivity for detection of participants with non-symptomatic CRC. Therefore, research approaches have been initiated to develop screening concepts based on biomarkers in blood. Preliminary results show that protein, genetic, epigenetic, and metabolomic components may be valuable in blood-based screening concepts, particularly when combinations of the various components appear to lead to significant improvements.

OBJECTIVES: The protocol described in this paper focuses on the validation of concepts based on biomarkers in blood in a major population screened by FIT.

METHODS: In Part 1, participants will be identified and included through the Danish CRC Screening Program comprising initial FIT and subsequent colonoscopy to those with a positive result. Blood samples will be collected from 8000 FIT-positive participants, who are offered subsequent colonoscopy. Findings and interventions at colonoscopy together with personal data including co-morbidity will be recorded. Blood samples and data will also be collected from 6000 arbitrarily chosen participants with negative FIT. In Part 2, blood samples and data will be collected from 30,000 FIT-negative participants three times within 4 years. The blood samples will be analyzed using various in-house and commercially available manual and automated analysis platforms.

RESULTS: We anticipate Part 1 to terminate late August 2016 and Part 2 to terminate late September 2022. The results from Parts 1 and 2 will be presented within 12 to 18 months from termination.

CONCLUSIONS: The purpose of this study is to improve the efficacy of identifying participants with neoplastic bowel lesions, to identify false negative participants, to identify participants at risk of interval neoplastic lesions, to improve the compliance in screening sessions, and to establish guidelines for out-patient follow-up of at-risk participants based on combinations of blood-based biomarkers.

Original language	English
Article number	e182
Journal	J M I R Research Protocols
Volume	5
Issue number	3
Number of pages	8
ISSN	1929-0748
DOIs	https://doi.org/10.2196/resprot.6346
Publication status	Published - Jul 2016

Keywords

Journal Article

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.2196/resprot.6346

Cite this

Rasmussen, L., Wilhelmsen, M., Christensen, I. J., Andersen, J., Jørgensen, L. N., Rasmussen, M., Hendel, J. W., Madsen, M. R., Vilandt, J., Hillig, T., Klærke, M., Münster, A-M. B., Andersen, L. M., Andersen, B., Hornung, N., Erlandsen, E. J., Khalid, A., & phw435, P. (2016). Protocol Outlines for Parts 1 and 2 of the Prospective Endoscopy III Study for the Early Detection of Colorectal Cancer: Validation of a Concept Based on Blood Biomarkers. J M I R Research Protocols, 5(3), [e182]. https://doi.org/10.2196/resprot.6346

Protocol Outlines for Parts 1 and 2 of the Prospective Endoscopy III Study for the Early Detection of Colorectal Cancer : Validation of a Concept Based on Blood Biomarkers. / Rasmussen, Louise; Wilhelmsen, Michael; Christensen, Ib Jarle et al.

In: J M I R Research Protocols, Vol. 5, No. 3, e182, 07.2016.

Research output: Contribution to journal › Journal article › Research › peer-review

Rasmussen, L, Wilhelmsen, M, Christensen, IJ, Andersen, J, Jørgensen, LN, Rasmussen, M, Hendel, JW, Madsen, MR, Vilandt, J, Hillig, T, Klærke, M, Münster, A-MB, Andersen, LM, Andersen, B, Hornung, N, Erlandsen, EJ, Khalid, A & phw435, P 2016, 'Protocol Outlines for Parts 1 and 2 of the Prospective Endoscopy III Study for the Early Detection of Colorectal Cancer: Validation of a Concept Based on Blood Biomarkers', J M I R Research Protocols, vol. 5, no. 3, e182. https://doi.org/10.2196/resprot.6346

@article{6ab1afabaf7f467bb94b4d9f3d6d037f,

title = "Protocol Outlines for Parts 1 and 2 of the Prospective Endoscopy III Study for the Early Detection of Colorectal Cancer: Validation of a Concept Based on Blood Biomarkers",

abstract = "BACKGROUND: Programs for population screening of colorectal cancer (CRC) have been implemented in several countries with fecal immunochemical testing (FIT) as the preferred platform. However, the major obstacle for a feces-based testing method is the limited compliance that reduces the clinical sensitivity for detection of participants with non-symptomatic CRC. Therefore, research approaches have been initiated to develop screening concepts based on biomarkers in blood. Preliminary results show that protein, genetic, epigenetic, and metabolomic components may be valuable in blood-based screening concepts, particularly when combinations of the various components appear to lead to significant improvements.OBJECTIVES: The protocol described in this paper focuses on the validation of concepts based on biomarkers in blood in a major population screened by FIT.METHODS: In Part 1, participants will be identified and included through the Danish CRC Screening Program comprising initial FIT and subsequent colonoscopy to those with a positive result. Blood samples will be collected from 8000 FIT-positive participants, who are offered subsequent colonoscopy. Findings and interventions at colonoscopy together with personal data including co-morbidity will be recorded. Blood samples and data will also be collected from 6000 arbitrarily chosen participants with negative FIT. In Part 2, blood samples and data will be collected from 30,000 FIT-negative participants three times within 4 years. The blood samples will be analyzed using various in-house and commercially available manual and automated analysis platforms.RESULTS: We anticipate Part 1 to terminate late August 2016 and Part 2 to terminate late September 2022. The results from Parts 1 and 2 will be presented within 12 to 18 months from termination.CONCLUSIONS: The purpose of this study is to improve the efficacy of identifying participants with neoplastic bowel lesions, to identify false negative participants, to identify participants at risk of interval neoplastic lesions, to improve the compliance in screening sessions, and to establish guidelines for out-patient follow-up of at-risk participants based on combinations of blood-based biomarkers.",

keywords = "Journal Article",

author = "Louise Rasmussen and Michael Wilhelmsen and Christensen, {Ib Jarle} and Jens Andersen and J{\o}rgensen, {Lars Nannestad} and Morten Rasmussen and Hendel, {Jakob W.} and Madsen, {Mogens R.} and Jesper Vilandt and Thore Hillig and Michael Kl{\ae}rke and M{\"u}nster, {Anna-Marie Bloch} and Andersen, {Lars M.} and Berit Andersen and Nete Hornung and Erlandsen, {Erland J.} and Ali Khalid and phw435 phw435",

year = "2016",

month = jul,

doi = "10.2196/resprot.6346",

language = "English",

volume = "5",

journal = "JMIR Research Protocols",

issn = "1929-0748",

publisher = "J M I R Publications, Inc.",

number = "3",

}

TY - JOUR

T1 - Protocol Outlines for Parts 1 and 2 of the Prospective Endoscopy III Study for the Early Detection of Colorectal Cancer

T2 - Validation of a Concept Based on Blood Biomarkers

AU - Rasmussen, Louise

AU - Wilhelmsen, Michael

AU - Christensen, Ib Jarle

AU - Andersen, Jens

AU - Jørgensen, Lars Nannestad

AU - Rasmussen, Morten

AU - Hendel, Jakob W.

AU - Madsen, Mogens R.

AU - Vilandt, Jesper

AU - Hillig, Thore

AU - Klærke, Michael

AU - Münster, Anna-Marie Bloch

AU - Andersen, Lars M.

AU - Andersen, Berit

AU - Hornung, Nete

AU - Erlandsen, Erland J.

AU - Khalid, Ali

AU - phw435, phw435

PY - 2016/7

Y1 - 2016/7

N2 - BACKGROUND: Programs for population screening of colorectal cancer (CRC) have been implemented in several countries with fecal immunochemical testing (FIT) as the preferred platform. However, the major obstacle for a feces-based testing method is the limited compliance that reduces the clinical sensitivity for detection of participants with non-symptomatic CRC. Therefore, research approaches have been initiated to develop screening concepts based on biomarkers in blood. Preliminary results show that protein, genetic, epigenetic, and metabolomic components may be valuable in blood-based screening concepts, particularly when combinations of the various components appear to lead to significant improvements.OBJECTIVES: The protocol described in this paper focuses on the validation of concepts based on biomarkers in blood in a major population screened by FIT.METHODS: In Part 1, participants will be identified and included through the Danish CRC Screening Program comprising initial FIT and subsequent colonoscopy to those with a positive result. Blood samples will be collected from 8000 FIT-positive participants, who are offered subsequent colonoscopy. Findings and interventions at colonoscopy together with personal data including co-morbidity will be recorded. Blood samples and data will also be collected from 6000 arbitrarily chosen participants with negative FIT. In Part 2, blood samples and data will be collected from 30,000 FIT-negative participants three times within 4 years. The blood samples will be analyzed using various in-house and commercially available manual and automated analysis platforms.RESULTS: We anticipate Part 1 to terminate late August 2016 and Part 2 to terminate late September 2022. The results from Parts 1 and 2 will be presented within 12 to 18 months from termination.CONCLUSIONS: The purpose of this study is to improve the efficacy of identifying participants with neoplastic bowel lesions, to identify false negative participants, to identify participants at risk of interval neoplastic lesions, to improve the compliance in screening sessions, and to establish guidelines for out-patient follow-up of at-risk participants based on combinations of blood-based biomarkers.

AB - BACKGROUND: Programs for population screening of colorectal cancer (CRC) have been implemented in several countries with fecal immunochemical testing (FIT) as the preferred platform. However, the major obstacle for a feces-based testing method is the limited compliance that reduces the clinical sensitivity for detection of participants with non-symptomatic CRC. Therefore, research approaches have been initiated to develop screening concepts based on biomarkers in blood. Preliminary results show that protein, genetic, epigenetic, and metabolomic components may be valuable in blood-based screening concepts, particularly when combinations of the various components appear to lead to significant improvements.OBJECTIVES: The protocol described in this paper focuses on the validation of concepts based on biomarkers in blood in a major population screened by FIT.METHODS: In Part 1, participants will be identified and included through the Danish CRC Screening Program comprising initial FIT and subsequent colonoscopy to those with a positive result. Blood samples will be collected from 8000 FIT-positive participants, who are offered subsequent colonoscopy. Findings and interventions at colonoscopy together with personal data including co-morbidity will be recorded. Blood samples and data will also be collected from 6000 arbitrarily chosen participants with negative FIT. In Part 2, blood samples and data will be collected from 30,000 FIT-negative participants three times within 4 years. The blood samples will be analyzed using various in-house and commercially available manual and automated analysis platforms.RESULTS: We anticipate Part 1 to terminate late August 2016 and Part 2 to terminate late September 2022. The results from Parts 1 and 2 will be presented within 12 to 18 months from termination.CONCLUSIONS: The purpose of this study is to improve the efficacy of identifying participants with neoplastic bowel lesions, to identify false negative participants, to identify participants at risk of interval neoplastic lesions, to improve the compliance in screening sessions, and to establish guidelines for out-patient follow-up of at-risk participants based on combinations of blood-based biomarkers.

KW - Journal Article

U2 - 10.2196/resprot.6346

DO - 10.2196/resprot.6346

M3 - Journal article

C2 - 27624815

SN - 1929-0748

VL - 5

JO - JMIR Research Protocols

JF - JMIR Research Protocols

IS - 3

M1 - e182

ER -

Protocol Outlines for Parts 1 and 2 of the Prospective Endoscopy III Study for the Early Detection of Colorectal Cancer: Validation of a Concept Based on Blood Biomarkers

Abstract

Keywords

UN SDGs

Access to Document

Fingerprint

Cite this