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Randomized Controlled Trial
. 2025 Jul;32(7):5092-5101.
doi: 10.1245/s10434-025-16890-0. Epub 2025 Feb 5.

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

Esther N Dekker  1 , Quisette P Janssen  1 , Jacob L van Dam  1 , Gaby J Strijk  1 , Eva M M Verkolf  1 , Sridhar Kandala  2 , Jasper Dumas  3 , Amine Fellah  3 , Eileen M O'Reilly  4 , Marc G Besselink  5   6 , Casper H J van Eijck  1 , Marjolein Y V Homs  2 , Geert-Jan van Tienhoven  5   7 , Johanna W Wilmink  5   8 , Dana A M Mustafa  3 , Bas Groot Koerkamp  9 ; Dutch Pancreatic Cancer Group
Collaborators, Affiliations
Randomized Controlled Trial

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

Esther N Dekker et al. Ann Surg Oncol. 2025 Jul.

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.

Keywords: Biomarkers; Pancreatic cancer; Personalized medicine; Randomized controlled trial.

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Conflict of interest statement

Disclosure: Eileen M. O’Reilly received research funding for the institution from Genentech/Roche, BioNTech, AstraZeneca, Arcus, Elicio, Parker Institute, NIH/NCI, and Digestive Care. She is consulting/DSMB for Arcus, Ability Pharma, Alligator Bioscience, BioNTech, Ipsen, Merck, Novartis, Syros, Leap Therapeutics, Astellas, Autem, BMS, Revolution Medicine, Tempus, Fibrogen, Merus, Revi Agios (spouse), Genentech-Roche (spouse), Eisai (spouse), and Servier (Spouse). Johanna W. Wilmink is consulting/advisor for MSD, Servier, Novartis, Astra Zeneca, and Nordic. She has received research funding for the institution from Servier, Nordic, and MSD. Casper H. J. van Eijck is consultant for AIM ImunnoTech. The remaining authors have no conflicts of interest.

Figures

Fig. 1
Fig. 1
Schematic representation of the PREOPANC-2 trial with associated blood sampling moments from randomization until the end of treatment
Fig. 2
Fig. 2
Blood sample tubes collected in the PREOPANC-2 trial
Fig. 3
Fig. 3
Flowchart of blood sample collection
See this image and copyright information in PMC

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