Treatment outcomes of esophageal cancer in Eastern Africa: protocol of a multi-center, prospective, observational, open cohort study.

Treatment outcomes of esophageal cancer in Eastern Africa: protocol of a multi-center, prospective, observational, open cohort study.
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DOI:
10.1186/s12885-021-09124-5
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发表时间:
2022-01-19
期刊:
影响因子:
3.8
通讯作者:
of the African Esophageal Cancer Consortium (AfrECC)
of the African Esophageal Cancer Consortium (AfrECC)
中科院分区:
医学2区
文献类型:
--
作者:
Buckle GC;Mrema A;Mwachiro M;Ringo Y;Selekwa M;Mulima G;Some FF;Mmbaga BT;Mody GN;Zhang L;Paciorek A;Akoko L;Ayuo P;Burgert S;Bukusi E;Charles A;Chepkemoi W;Chesumbai G;Kaimila B;Kenseko A;Kibwana KS;Koech D;Macharia C;Moirana EN;Mushi BP;Mremi A;Mwaiselage J;Mwanga A;Ndumbalo J;Nvakunga G;Ngoma M;Oduor M;Oloo M;Opakas J;Parker R;Seno S;Salima A;Servent F;Wandera A;Westmoreland KD;White RE;Williams B;Mmbaga EJ;Van Loon K;of the African Esophageal Cancer Consortium (AfrECC)

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食管鳞状细胞癌(ESCC)是东非癌症发病率和死亡率的主要原因。东非大多数食管鳞癌患者在诊断时已处于晚期疾病。目前该地区正在使用几种针对 ESCC 的姑息干预措施,包括化疗、联合或不联合化疗的放射治疗,以及使用自扩张金属支架的食管支架置入术;然而,这些干预措施在资源匮乏的情况下的相对有效性还有待检验。这项前瞻性、观察性、多中心、开放队列研究旨在描述东非食管鳞癌的治疗前景,并调查该地区不同治疗策略的结果。这项为期4.5年的研究将在肯尼亚、马拉维和坦桑尼亚总共六个地点进行招募(坦桑尼亚达累斯萨拉姆的海洋路癌症研究所和穆希姆比利国家医院;坦桑尼亚莫希的乞力马扎罗基督教医疗中心;肯尼亚博梅特的Tenwek医院;肯尼亚埃尔多雷特的莫伊教学和转诊医院;以及马拉维利隆圭的卡穆祖中央医院)。将评估的治疗结果包括总体生存率、生活质量 (QOL) 和安全性。所有在参与中心就诊且根据内窥镜检查或吞钡经组织病理学证实或推定临床诊断为 ESCC 的患者(≥18 岁)都将被招募参加。包括标准化 QOL 指标在内的关键临床和治疗相关数据将在研究入组时、治疗后 1 个月、治疗后 3 个月以及此后每隔 3 个月收集一次,直至死亡。将通过手机外展收集生命状况和生活质量数据。这项研究将是第一个前瞻性比较东非食管鳞癌治疗策略的研究,也是第一个调查撒哈拉以南非洲不同治疗方法带来的生活质量益处的研究。这项研究的结果将有助于确定东非和其他资源有限地区 ESCC 的最佳管理策略,并将作为未来研究的基准。该研究于 2021 年 12 月 15 日在 ClinicalTrials.gov 数据库中进行回顾性注册,编号为 NCT05177393。在线版本包含可在 10.1186/s12885-021-09124-5 获取的补充材料。
Esophageal squamous cell carcinoma (ESCC) is a major cause of cancer morbidity and mortality in Eastern Africa. The majority of patients with ESCC in Eastern Africa present with advanced disease at the time of diagnosis. Several palliative interventions for ESCC are currently in use within the region, including chemotherapy, radiation therapy with and without chemotherapy, and esophageal stenting with self-expandable metallic stents; however, the comparative effectiveness of these interventions in a low resource setting has yet to be examined. This prospective, observational, multi-center, open cohort study aims to describe the therapeutic landscape of ESCC in Eastern Africa and investigate the outcomes of different treatment strategies within the region. The 4.5-year study will recruit at a total of six sites in Kenya, Malawi and Tanzania (Ocean Road Cancer Institute and Muhimbili National Hospital in Dar es Salaam, Tanzania; Kilimanjaro Christian Medical Center in Moshi, Tanzania; Tenwek Hospital in Bomet, Kenya; Moi Teaching and Referral Hospital in Eldoret, Kenya; and Kamuzu Central Hospital in Lilongwe, Malawi). Treatment outcomes that will be evaluated include overall survival, quality of life (QOL) and safety. All patients (≥18 years old) who present to participating sites with a histopathologically-confirmed or presumptive clinical diagnosis of ESCC based on endoscopy or barium swallow will be recruited to participate. Key clinical and treatment-related data including standardized QOL metrics will be collected at study enrollment, 1 month following treatment, 3 months following treatment, and thereafter at 3-month intervals until death. Vital status and QOL data will be collected through mobile phone outreach. This study will be the first study to prospectively compare ESCC treatment strategies in Eastern Africa, and the first to investigate QOL benefits associated with different treatments in sub-Saharan Africa. Findings from this study will help define optimal management strategies for ESCC in Eastern Africa and other resource-limited settings and will serve as a benchmark for future research. This study was retrospectively registered with the ClinicalTrials.gov database on December 15, 2021, NCT05177393. The online version contains supplementary material available at 10.1186/s12885-021-09124-5.
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