Transdisciplinary Team Science in Colorectal Cancer Prognosis: the ColoCare Study

摘要 结直肠癌(CRC)是美国男性和女性中第二常见的癌症，导致 每年有超过50,000人死亡。研究旨在减轻CRC的高负担，发现/验证新的 与预后相关的生物标记物，应对日益严重的早发性结直肠癌流行，以及对抗 儿童权利公约在未得到充分服务的人口中的差距具有紧迫的重要性。结直肠癌患者队列包括不同的 人口和纵向确定临床数据和生物谱对于追求这些关键的 目标。ColoCare研究是一项新加入的大型多机构前瞻性生存队列研究 来自不同种族/民族和地理背景的确诊结直肠癌患者。CRC存续 队列是罕见的，ColoCare是独一无二的，因为它收集了详细的流行病学和临床数据，以及 在多个时间点的生物标本的多样性。这种设计使创新的生存研究成为可能 涵盖生活方式/行为因素、种族/民族CRC差异，以及旨在发现 以及验证与不良结直肠癌风险相关的新的基于分子、血液和微生物组的生物标志物 结果。这样的研究可以为治疗决策、旨在改善关键临床的干预措施提供信息 和患者报告的结果，以及新疗法的发展。 ColoCare研究招募了3000名患者，平均随访时间为2.1年。 收集包括肿瘤组织和系列血液、粪便和尿液样本。尽管这是一个年轻的群体， ColoCare已经支持了70篇发表的论文和79个项目，其中包括72名外部调查人员。 持续的U01基础设施支持对于维持和发展这一CRC生存的宝贵资源至关重要 研究。在这里，我们将实现以下目标：(1)将队列规模从3361人增加到4157人 参与者，包括加强招募服务不足和研究不足的人口，这些人经历了 在结直肠癌结果和接受新疗法的患者之间存在显著差异。(2)延长参与者跟进时间 通过积极的跟踪(生物显微镜；问卷；病历摘要)和 被动随访(SEER/州癌症登记和国家死亡指数)。(三)保持和扩大 ColoCare生物库，包括收集肿瘤组织样本和纵向采集血液和 粪便样本。(4)维护和扩展ColoCare中心数据仓库，我们研究的能力 门户，鼓励和促进外部和内部调查人员的请求，并与我们的 社区咨询委员会推动病人参与和公众传播知识 由ColoCare生成。在持续的基础设施支持下，这一独特而全面的资源将 继续开展广泛的有影响力的结直肠癌存活期研究。

SUMMARY Colorectal cancer (CRC) is the second most common cancer among men and women in the U.S., leading to over 50,000 deaths per year. Research aimed at reducing CRC’s high burden, discovering/validating novel biomarkers associated with prognosis, addressing the growing epidemic of early-onset CRC, and countering CRC disparities in underserved populations is of pressing importance. CRC patient cohorts that include diverse populations and longitudinally ascertain clinical data and biospecimens are essential for pursuing these critical objectives. The ColoCare Study is a large, multi-institutional prospective survivorship cohort that enrolls newly diagnosed patients with CRC from diverse racial/ethnic and geographic backgrounds. CRC survivorship cohorts are rare and ColoCare is unique given its collection of detailed epidemiologic and clinical data and a variety of biospecimens at multiple time points. This design enables innovative survivorship research that spans lifestyle/behavioral factors, racial/ethnic CRC disparities, and translational studies aimed at discovering and validating novel molecular, blood- and microbiome-based biomarkers related to the risk of adverse CRC outcomes. Such research can inform treatment decision-making, interventions aimed at improving key clinical and patient reported outcomes, and the development of novel therapeutics. The ColoCare Study has enrolled >3,000 patients with a median of 2.1 years of follow-up and biospecimen collections including tumor tissue and serial blood, stool, and urine samples. Despite being a young cohort, ColoCare has already supported 70 published papers and 79 projects that include 72 external investigators. Continued U01 infrastructure support is critical to sustain and grow this valuable resource for CRC survivorship research. Here, we will pursue the following aims: (1) Increase the size of the cohort from 3,361 to 4,157 participants, including enhanced recruitment of underserved and understudied populations who experience significant disparities in CRC outcomes, and patients receiving novel therapies. (2) Extend participant follow-up to 5-years through both active follow-up (biospecimens; questionnaires; medical record abstractions) and passive follow-up (SEER/state cancer registries and National Death Index). (3) Maintain and expand the ColoCare biorepository, including collection of tumor tissue samples and longitudinal collections of blood and stool samples. (4) Maintain and expand the ColoCare Central Data Warehouse, the capabilities of our study portal to encourage and facilitate requests from external and internal investigators, and engagement with our Community Advisory Board to advance patient participation and the public dissemination of knowledge generated by ColoCare. With continued infrastructure support, this unique and comprehensive resource will continue to enable a wide-range of impactful colorectal cancer survivorship research.