Blood Sample Collection in Randomized Controlled Trials for Biomarker Discovery and Validation: Experience of the PREOPANC-2 Trial

Esther N. Dekker; Quisette P. Janssen; Dutch Pancreatic Cancer Group; Jacob L. van Dam; Gaby J. Strijk; Eva M.M. Verkolf; Sridhar Kandala; Jasper Dumas; Amine Fellah; Eileen M. O’Reilly; Marc G. Besselink; Casper H.J. van Eijck; Marjolein Y.V. Homs; Geert Jan van Tienhoven; Johanna W. Wilmink; Dana A.M. Mustafa; Bas Groot Koerkamp; R. F. de Wilde; J. de Vos - Geelen; E. Versteijne; A. ten Tije; M. M. Streppel; M. W.J. Stommel; H. C. van Santvoort; G. A. Patijn; D. ten Oever; J. J.M.E. Nuyttens; V. B. Nieuwenhuijs; J. S.D. Mieog; C. M. Luyer; S. A.C. Luelmo; O. J.L. Loosveld; M. S.L. Liem; M. B. van der Kolk; G. Kazemier; T. M. Karsten; I. H.J.T. de Hingh; B. C.M. Haberkorn; J. W.B. de Groot; P. P.L.O. Coene; G. Cirkel; O. R. Busch; A. M.E. Bruynzeel; L. Brouwer-Hol; S. A. Bouwense; K. P. Bosscha; H. Bos; B. A. Bonsing; M. L. van Bekkum; L. V. Beerepoot

doi:10.1245/s10434-025-16890-0

Blood Sample Collection in Randomized Controlled Trials for Biomarker Discovery and Validation: Experience of the PREOPANC-2 Trial

Esther N. Dekker, Quisette P. Janssen, Dutch Pancreatic Cancer Group, Jacob L. van Dam, Gaby J. Strijk, Eva M.M. Verkolf, Sridhar Kandala, Jasper Dumas, Amine Fellah, Eileen M. O’Reilly, Marc G. Besselink, Casper H.J. van Eijck, Marjolein Y.V. Homs, Geert Jan van Tienhoven, Johanna W. Wilmink, Dana A.M. Mustafa, Bas Groot Koerkamp^*, R. F. de Wilde, J. de Vos - Geelen, E. VersteijneA. ten Tije, M. M. Streppel, M. W.J. Stommel, H. C. van Santvoort, G. A. Patijn, D. ten Oever, J. J.M.E. Nuyttens, V. B. Nieuwenhuijs, J. S.D. Mieog, C. M. Luyer, S. A.C. Luelmo, O. J.L. Loosveld, M. S.L. Liem, M. B. van der Kolk, G. Kazemier, T. M. Karsten, I. H.J.T. de Hingh, B. C.M. Haberkorn, J. W.B. de Groot, P. P.L.O. Coene, G. Cirkel, O. R. Busch, A. M.E. Bruynzeel, L. Brouwer-Hol, S. A. Bouwense, K. P. Bosscha, H. Bos, B. A. Bonsing, M. L. van Bekkum, L. V. Beerepoot

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

Background:

This study aimed to investigate the feasibility and yield of blood sample collection in an investigator-initiated nationwide randomized controlled trial (RCT).

Methods:

In the PREOPANC-2 trial, 375 patients with (borderline) resectable pancreatic cancer were randomly assigned to two neoadjuvant regiments in 19 centers in the Netherlands (2018–2021). Blood sample collection was scheduled at seven time points before, during, and after treatment. The primary outcome was the proportion of successfully collected blood samples at each scheduled time point.

Results:

Of the 375 randomized patients, 12 were excluded from blood sample collection before any treatment. From the remaining 363 patients, 1513 (87 %) of 1748 blood samples were collected, processed, mailed, and centrally stored. The blood samples were collected before treatment from 347 (96 %) of the 363 patients, after the first neoadjuvant cycle from 322 (94 %) of 343 patients, after neoadjuvant treatment (i.e., before surgery) from 260 (83 %) of 313 patients, and after surgery from 210 (77 %) of 271 patients. During the follow-up visits, blood samples were collected from 147 (82 %) of 179 patients 12 months after randomization and from 83 (77 %) of 108 patients after 24 months. A total of 220 samples (13 %) were missing. The most common causes for missing blood samples were scheduling oversights, unsuccessful blood draw attempts, and mailing failures (151 times, 69 %). Blood sample collection was canceled 69 times (31 %) due to COVID-19.

Conclusion:

Blood sample collection in the PREOPANC-2 trial had a yield of 96 % before treatment and an overall yield of 87 %. Collection of blood samples for biomarker studies is feasible in a nationwide RCT.

Original language	English
Article number	102019
Pages (from-to)	5092-5101
Number of pages	10
Journal	Annals of Surgical Oncology
Volume	32
Issue number	7
DOIs	https://doi.org/10.1245/s10434-025-16890-0
Publication status	Published - 5 Feb 2025

Bibliographical note

Publisher Copyright:
© The Author(s) 2025.

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

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Cite this

Dekker, E. N., Janssen, Q. P., Dutch Pancreatic Cancer Group, van Dam, J. L., Strijk, G. J., Verkolf, E. M. M., Kandala, S., Dumas, J., Fellah, A., O’Reilly, E. M., Besselink, M. G., van Eijck, C. H. J., Homs, M. Y. V., van Tienhoven, G. J., Wilmink, J. W., Mustafa, D. A. M., Groot Koerkamp, B., de Wilde, R. F., de Vos - Geelen, J., ... Beerepoot, L. V. (2025). Blood Sample Collection in Randomized Controlled Trials for Biomarker Discovery and Validation: Experience of the PREOPANC-2 Trial. Annals of Surgical Oncology, 32(7), 5092-5101. Article 102019. https://doi.org/10.1245/s10434-025-16890-0

@article{649627c61f90468d93cd36d4785f3734,

title = "Blood Sample Collection in Randomized Controlled Trials for Biomarker Discovery and Validation: Experience of the PREOPANC-2 Trial",

abstract = "Background: This study aimed to investigate the feasibility and yield of blood sample collection in an investigator-initiated nationwide randomized controlled trial (RCT). Methods:In the PREOPANC-2 trial, 375 patients with (borderline) resectable pancreatic cancer were randomly assigned to two neoadjuvant regiments in 19 centers in the Netherlands (2018–2021). Blood sample collection was scheduled at seven time points before, during, and after treatment. The primary outcome was the proportion of successfully collected blood samples at each scheduled time point. Results: Of the 375 randomized patients, 12 were excluded from blood sample collection before any treatment. From the remaining 363 patients, 1513 (87 \%) of 1748 blood samples were collected, processed, mailed, and centrally stored. The blood samples were collected before treatment from 347 (96 \%) of the 363 patients, after the first neoadjuvant cycle from 322 (94 \%) of 343 patients, after neoadjuvant treatment (i.e., before surgery) from 260 (83 \%) of 313 patients, and after surgery from 210 (77 \%) of 271 patients. During the follow-up visits, blood samples were collected from 147 (82 \%) of 179 patients 12 months after randomization and from 83 (77 \%) of 108 patients after 24 months. A total of 220 samples (13 \%) were missing. The most common causes for missing blood samples were scheduling oversights, unsuccessful blood draw attempts, and mailing failures (151 times, 69 \%). Blood sample collection was canceled 69 times (31 \%) due to COVID-19. Conclusion: Blood sample collection in the PREOPANC-2 trial had a yield of 96 \% before treatment and an overall yield of 87 \%. Collection of blood samples for biomarker studies is feasible in a nationwide RCT.",

author = "Dekker, \{Esther N.\} and Janssen, \{Quisette P.\} and \{Dutch Pancreatic Cancer Group\} and \{van Dam\}, \{Jacob L.\} and Strijk, \{Gaby J.\} and Verkolf, \{Eva M.M.\} and Sridhar Kandala and Jasper Dumas and Amine Fellah and O{\textquoteright}Reilly, \{Eileen M.\} and Besselink, \{Marc G.\} and \{van Eijck\}, \{Casper H.J.\} and Homs, \{Marjolein Y.V.\} and \{van Tienhoven\}, \{Geert Jan\} and Wilmink, \{Johanna W.\} and Mustafa, \{Dana A.M.\} and \{Groot Koerkamp\}, Bas and \{de Wilde\}, \{R. F.\} and \{de Vos - Geelen\}, J. and E. Versteijne and \{ten Tije\}, A. and Streppel, \{M. M.\} and Stommel, \{M. W.J.\} and \{van Santvoort\}, \{H. C.\} and Patijn, \{G. A.\} and \{ten Oever\}, D. and Nuyttens, \{J. J.M.E.\} and Nieuwenhuijs, \{V. B.\} and Mieog, \{J. S.D.\} and Luyer, \{C. M.\} and Luelmo, \{S. A.C.\} and Loosveld, \{O. J.L.\} and Liem, \{M. S.L.\} and \{van der Kolk\}, \{M. B.\} and G. Kazemier and Karsten, \{T. M.\} and \{de Hingh\}, \{I. H.J.T.\} and Haberkorn, \{B. C.M.\} and \{de Groot\}, \{J. W.B.\} and Coene, \{P. P.L.O.\} and G. Cirkel and Busch, \{O. R.\} and Bruynzeel, \{A. M.E.\} and L. Brouwer-Hol and Bouwense, \{S. A.\} and Bosscha, \{K. P.\} and H. Bos and Bonsing, \{B. A.\} and \{van Bekkum\}, \{M. L.\} and Beerepoot, \{L. V.\}",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2025.",

year = "2025",

month = feb,

day = "5",

doi = "10.1245/s10434-025-16890-0",

language = "English",

volume = "32",

pages = "5092--5101",

journal = "Annals of Surgical Oncology",

issn = "1068-9265",

publisher = "Springer Science+Business Media",

number = "7",

}

Dekker, EN, Janssen, QP, Dutch Pancreatic Cancer Group, van Dam, JL, Strijk, GJ, Verkolf, EMM, Kandala, S, Dumas, J, Fellah, A, O’Reilly, EM, Besselink, MG, van Eijck, CHJ , Homs, MYV, van Tienhoven, GJ, Wilmink, JW, Mustafa, DAM , Groot Koerkamp, B , de Wilde, RF, de Vos - Geelen, J, Versteijne, E, ten Tije, A, Streppel, MM, Stommel, MWJ, van Santvoort, HC, Patijn, GA, ten Oever, D, Nuyttens, JJME, Nieuwenhuijs, VB, Mieog, JSD, Luyer, CM, Luelmo, SAC, Loosveld, OJL, Liem, MSL, van der Kolk, MB, Kazemier, G, Karsten, TM, de Hingh, IHJT, Haberkorn, BCM, de Groot, JWB, Coene, PPLO, Cirkel, G, Busch, OR, Bruynzeel, AME, Brouwer-Hol, L, Bouwense, SA, Bosscha, KP, Bos, H, Bonsing, BA, van Bekkum, ML & Beerepoot, LV 2025, 'Blood Sample Collection in Randomized Controlled Trials for Biomarker Discovery and Validation: Experience of the PREOPANC-2 Trial', Annals of Surgical Oncology, vol. 32, no. 7, 102019, pp. 5092-5101. https://doi.org/10.1245/s10434-025-16890-0

Blood Sample Collection in Randomized Controlled Trials for Biomarker Discovery and Validation: Experience of the PREOPANC-2 Trial. / Dekker, Esther N.; Janssen, Quisette P.; Dutch Pancreatic Cancer Group et al.
In: Annals of Surgical Oncology, Vol. 32, No. 7, 102019, 05.02.2025, p. 5092-5101.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Blood Sample Collection in Randomized Controlled Trials for Biomarker Discovery and Validation

T2 - Experience of the PREOPANC-2 Trial

AU - Dekker, Esther N.

AU - Janssen, Quisette P.

AU - Dutch Pancreatic Cancer Group

AU - van Dam, Jacob L.

AU - Strijk, Gaby J.

AU - Verkolf, Eva M.M.

AU - Kandala, Sridhar

AU - Dumas, Jasper

AU - Fellah, Amine

AU - O’Reilly, Eileen M.

AU - Besselink, Marc G.

AU - van Eijck, Casper H.J.

AU - Homs, Marjolein Y.V.

AU - van Tienhoven, Geert Jan

AU - Wilmink, Johanna W.

AU - Mustafa, Dana A.M.

AU - Groot Koerkamp, Bas

AU - de Wilde, R. F.

AU - de Vos - Geelen, J.

AU - Versteijne, E.

AU - ten Tije, A.

AU - Streppel, M. M.

AU - Stommel, M. W.J.

AU - van Santvoort, H. C.

AU - Patijn, G. A.

AU - ten Oever, D.

AU - Nuyttens, J. J.M.E.

AU - Nieuwenhuijs, V. B.

AU - Mieog, J. S.D.

AU - Luyer, C. M.

AU - Luelmo, S. A.C.

AU - Loosveld, O. J.L.

AU - Liem, M. S.L.

AU - van der Kolk, M. B.

AU - Kazemier, G.

AU - Karsten, T. M.

AU - de Hingh, I. H.J.T.

AU - Haberkorn, B. C.M.

AU - de Groot, J. W.B.

AU - Coene, P. P.L.O.

AU - Cirkel, G.

AU - Busch, O. R.

AU - Bruynzeel, A. M.E.

AU - Brouwer-Hol, L.

AU - Bouwense, S. A.

AU - Bosscha, K. P.

AU - Bos, H.

AU - Bonsing, B. A.

AU - van Bekkum, M. L.

AU - Beerepoot, L. V.

PY - 2025/2/5

Y1 - 2025/2/5

N2 - Background: This study aimed to investigate the feasibility and yield of blood sample collection in an investigator-initiated nationwide randomized controlled trial (RCT). Methods:In the PREOPANC-2 trial, 375 patients with (borderline) resectable pancreatic cancer were randomly assigned to two neoadjuvant regiments in 19 centers in the Netherlands (2018–2021). Blood sample collection was scheduled at seven time points before, during, and after treatment. The primary outcome was the proportion of successfully collected blood samples at each scheduled time point. Results: Of the 375 randomized patients, 12 were excluded from blood sample collection before any treatment. From the remaining 363 patients, 1513 (87 %) of 1748 blood samples were collected, processed, mailed, and centrally stored. The blood samples were collected before treatment from 347 (96 %) of the 363 patients, after the first neoadjuvant cycle from 322 (94 %) of 343 patients, after neoadjuvant treatment (i.e., before surgery) from 260 (83 %) of 313 patients, and after surgery from 210 (77 %) of 271 patients. During the follow-up visits, blood samples were collected from 147 (82 %) of 179 patients 12 months after randomization and from 83 (77 %) of 108 patients after 24 months. A total of 220 samples (13 %) were missing. The most common causes for missing blood samples were scheduling oversights, unsuccessful blood draw attempts, and mailing failures (151 times, 69 %). Blood sample collection was canceled 69 times (31 %) due to COVID-19. Conclusion: Blood sample collection in the PREOPANC-2 trial had a yield of 96 % before treatment and an overall yield of 87 %. Collection of blood samples for biomarker studies is feasible in a nationwide RCT.

AB - Background: This study aimed to investigate the feasibility and yield of blood sample collection in an investigator-initiated nationwide randomized controlled trial (RCT). Methods:In the PREOPANC-2 trial, 375 patients with (borderline) resectable pancreatic cancer were randomly assigned to two neoadjuvant regiments in 19 centers in the Netherlands (2018–2021). Blood sample collection was scheduled at seven time points before, during, and after treatment. The primary outcome was the proportion of successfully collected blood samples at each scheduled time point. Results: Of the 375 randomized patients, 12 were excluded from blood sample collection before any treatment. From the remaining 363 patients, 1513 (87 %) of 1748 blood samples were collected, processed, mailed, and centrally stored. The blood samples were collected before treatment from 347 (96 %) of the 363 patients, after the first neoadjuvant cycle from 322 (94 %) of 343 patients, after neoadjuvant treatment (i.e., before surgery) from 260 (83 %) of 313 patients, and after surgery from 210 (77 %) of 271 patients. During the follow-up visits, blood samples were collected from 147 (82 %) of 179 patients 12 months after randomization and from 83 (77 %) of 108 patients after 24 months. A total of 220 samples (13 %) were missing. The most common causes for missing blood samples were scheduling oversights, unsuccessful blood draw attempts, and mailing failures (151 times, 69 %). Blood sample collection was canceled 69 times (31 %) due to COVID-19. Conclusion: Blood sample collection in the PREOPANC-2 trial had a yield of 96 % before treatment and an overall yield of 87 %. Collection of blood samples for biomarker studies is feasible in a nationwide RCT.

UR - http://www.scopus.com/inward/record.url?scp=85218813675&partnerID=8YFLogxK

U2 - 10.1245/s10434-025-16890-0

DO - 10.1245/s10434-025-16890-0

M3 - Article

C2 - 39907876

AN - SCOPUS:85218813675

SN - 1068-9265

VL - 32

SP - 5092

EP - 5101

JO - Annals of Surgical Oncology

JF - Annals of Surgical Oncology

IS - 7

M1 - 102019

ER -

Blood Sample Collection in Randomized Controlled Trials for Biomarker Discovery and Validation: Experience of the PREOPANC-2 Trial

Abstract

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