Classification of chagasic colon disease.

Chagas disease (CD), caused by Trypanosoma cruzi, is a neglected tropical disease with significant public health implications. While its primary transmission occurs in endemic regions via triatomine vectors, migratory processes have led to an increased prevalence in non-endemic areas as in Spain where an estimated 50,000 people live with CD. Chronic Chagas cardiomyopathy (CCC) and digestive complications are the primary manifestations, yet diagnostic criteria, especially regarding organic involvement, and treatment indications are still a matter of debate. There is an urgent need for standardized approaches to improve care and identify biomarkers for progression and treatment response. The Chagas non-endemic cohort (ChaNoE) aims to recruit individuals with chronic CD across multiple centers in Spain. Inclusion criteria involve a confirmed diagnosis based on two serological tests. Participants will receive comprehensive diagnostic evaluations, including electrocardiography, echocardiography, and periodic serological and PCR assessments. Follow-up will focus on disease progression, particularly CCC and digestive involvement, using standardized protocols. The study also establishes a biobank for serum samples to facilitate biomarker research. The ChaNoE cohort addresses critical gaps in the understanding of CD in non-endemic regions. By standardizing diagnostic and treatment protocols, it seeks to harmonize care and enable comparisons with cohorts in endemic areas. The creation of a biobank supports the identification of biomarkers for disease progression and treatment efficacy, a current unmet need in CD management. This initiative also strengthens research networks and informs public health strategies to mitigate the burden of CD in non-endemic settings. Findings will be disseminated to key stakeholders to improve the clinical and epidemiological understanding of this neglected disease.恰加斯病（Chagas disease, CD）由克氏锥虫（Trypanosoma cruzi）引发，是一类对公共卫生具有重大影响的被忽视热带病。尽管其主要传播发生在流行地区，通过锥蝽媒介进行，但人口迁移活动导致非流行地区的患病率逐年攀升，例如西班牙，该国目前估计有5万名恰加斯病患者。慢性恰加斯心肌病（Chronic Chagas cardiomyopathy, CCC）与消化道并发症是该病的主要临床表现，但目前关于其诊断标准（尤其是涉及器官受累的部分）以及治疗指征仍存在广泛争议。当前亟需建立标准化诊疗方案，以优化临床照护，并识别可用于评估疾病进展与治疗反应的生物标志物。恰加斯病非流行队列（Chagas non-endemic cohort, ChaNoE）计划在西班牙多家临床中心招募慢性恰加斯病患者。其纳入标准为：经两项血清学检测确诊为恰加斯病。受试者将接受全面诊断评估，涵盖心电图、超声心动图，以及定期血清学检测与聚合酶链式反应（PCR）检测。随访将采用标准化方案，重点监测疾病进展情况，尤其是慢性恰加斯心肌病与消化道受累表现。本研究同步建立血清样本生物样本库，以助力生物标志物相关研究。该队列填补了当前学界对非流行地区恰加斯病认知的关键空白。通过标准化诊疗方案，本研究旨在统一临床照护标准，并实现与流行地区相关队列的研究对比。生物样本库的建立将助力识别用于评估疾病进展与治疗效果的生物标志物，而这正是当前恰加斯病诊疗中尚未满足的核心需求。本项目同时强化了跨区域研究网络，并为制定公共卫生策略以减轻非流行地区的恰加斯病疾病负担提供科学依据。研究结果将向核心利益相关方进行传播，以提升业界对这一被忽视热带病的临床与流行病学认知。