Dekker Esther N, Janssen Quisette P, van Dam Jacob L, Strijk Gaby J, Verkolf Eva M M, Kandala Sridhar, Dumas Jasper, Fellah Amine, O'Reilly Eileen M, Besselink Marc G, van Eijck Casper H J, Homs Marjolein Y V, van Tienhoven Geert-Jan, Wilmink Johanna W, Mustafa Dana A M, Groot Koerkamp Bas
Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
Ann Surg Oncol. 2025 Feb 5. doi: 10.1245/s10434-025-16890-0.
This study aimed to investigate the feasibility and yield of blood sample collection in an investigator-initiated nationwide randomized controlled trial (RCT).
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.
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.
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.
本研究旨在调查在一项由研究者发起的全国性随机对照试验（RCT）中采集血样的可行性和成功率。
在PREOPANC - 2试验中，375例（临界）可切除胰腺癌患者被随机分配至荷兰19个中心的两个新辅助治疗方案组（2018 - 2021年）。在治疗前、治疗期间和治疗后安排了七个时间点采集血样。主要结局是在每个预定时间点成功采集血样的比例。
在375例随机分组的患者中，12例在任何治疗前被排除在血样采集之外。在其余363例患者中，1748份血样中的1513份（87%）被采集、处理、邮寄并集中存储。363例患者中有347例（96%）在治疗前采集了血样，343例患者中有322例（94%）在第一个新辅助周期后采集了血样，313例患者中有260例（83%）在新辅助治疗后（即手术前）采集了血样，271例患者中有210例（77%）在手术后采集了血样。在随访期间，随机分组后12个月，179例患者中有147例（82%）采集了血样；24个月后，108例患者中有83例（77%）采集了血样。共有220份样本（13%）缺失。血样缺失的最常见原因是日程安排疏忽、采血尝试未成功以及邮寄失败（151次，69%）。由于新冠疫情，血样采集取消了69次（31%）。
PREOPANC - 2试验中血样采集在治疗前的成功率为96%，总体成功率为87%。在全国性RCT中采集血样用于生物标志物研究是可行的。
