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临床试验/NCT03635216
NCT03635216Unknown不适用

The Biomarker Analysis in Locally Advanced Cervical Cancer

Mackay Memorial Hospital1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2018年5月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
62
试验地点
1
主要终点
Shh, Ptch-1, Smo and Gli1

研究概览

简要总结

Sonic hedgehog (Shh) signaling, including Gli1, is critical to treatment resistance. For optimizing cervical cancer treatment, the pathological prognostic factors determine whether to administer adjuvant therapy. However, the majority of clinical results was from squamous cell carcinoma, rendering conclusions for adenocarcinoma less convincing. We aimed to examine the role of Shh signaling in long-term clinical outcomes of cervical adenocarcinoma after receiving major surgery.

详细描述

Surgery, radiotherapy, and chemotherapy could achieve favorable locoregional control in cervical cancer. Although good local control results, distant failure plays a major role in patients with treatment failure.

We were interested in the potential biomarkers for recurrence after primary treatment for the following reasons. We wanted to identify patients at a high risk of recurrence. Such patients must be intensively monitored. We required baseline data, such as the actuarial relapse rate, for evaluation in an additional randomized study. Hence, we retrospectively analyzed the potential biomarkers for recurrence in cervical cancer. Statistical analysis of the data was done using the chi-square test. Disease free survival curves were constructed using the Kaplan-Meier method. Comparisons between curves were performed using the log-rank test. Multivariate analyses of factors associated with local and distant failure were made by logistic regression analysis.

From 1987 to 2002, 62 patients with cervical adenocarcinoma that received major surgery were enrolled for analysis of Shh signaling with a median follow-up period for 172.6 months (IQR 33.0-226.2 months). External beam radiotherapy with 50-60 Gy followed by brachytherapy with 30 Gy was delivered with or without concurrent weekly cisplatin 40 mg/m2. Clinical outcomes in terms of local recurrence, progression free survival (PFS) and overall survival (OS) will be analyzed. The expressions of Shh, Ptch-1, Smo and Gli1 were assessed by immunohistochemistry. Statistics will be performed using International Business Machines (IBM) Statistical Package for the Social Science (SPSS) v22.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • cervical cancer patients
  • performance status Eastern Cooperative Oncology Group 0-1 (ECOG 0-1)

排除标准

  • non-other cancer previously

结局指标

主要结局

Shh, Ptch-1, Smo and Gli1

时间窗: 1987-2002

Sonic hedgehog (Shh) signaling, including Gli1, is critical to treatment resistance. to examine the role of Shh signaling in long-term clinical outcomes of cervical adenocarcinoma after receiving major surgery

次要结局

  • overall survival(1987-2002)
  • local recurrence(1987-2002)
  • progression free survival(1987-2002)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu-Jen Chen

Chair

Mackay Memorial Hospital

研究点 (1)

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