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临床试验/NCT04537273
NCT04537273已完成不适用

Clinical and Pathological Characteristics as Prognostic Factors in Locally Advanced Cervical Cancer: A Retrospective Study

National Institute of Cancerología0 个研究点目标入组 1,954 人开始时间: 2005年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,954
主要终点
Analyze the clinical and pathological characteristics as prognostic factor of patients with locally advanced cervical cancer.

研究概览

简要总结

Locally advanced cervical cáncer continues to be a public health problem in emergent economies, even though treatment is very well standardized, recurrence rate is still high, making necessary to evaluate prognostic clinical and pathological factors. The aim of this study is to evaluate clinical and pathological prognostic factor in terms of treatment outcomes, disease-free survival (DFS) and overall survival (OS) in a retrospective cohort of patients with LACC treated with standard chemoradiotherapy in a reference center in México.

详细描述

This is a retrospective study, the data were obtained from clinical files of cervical cancer patients with clinical stages IB2-IVA(FIGO2009) treated at the Instituto Nacional de Cancerología in Mexico City from January 2005 to December 2014.

A total of 1954 patients with LACC confirmed by pathology, clinical exams and computed tomography scan (CT) were identified.

Demographic, clinical, pathological and follow-up as well as survival status of all patients was recorded. Treatment outcome was classified as complete response if the patient had no signs of tumor activity after 6 months of finishing treatment, persistence of disease was defined if tumor could be identified after treatment or before six months of treatment termination, progression was defined if tumor growth occurred or metastatic disease appeared. Disease-free survival (DFS) was defined as the period between finishing treatment and the occurrence of relapse, which was confirmed by pathological study and/or CT. Overall survival (OS) was defined as the time period between diagnosis and death or date at last visit. Quantitative variables were described with central tendency and dispersion measures and analyzed with Student's t or Mann-Whitney U test. Normality was determined with Shapiro-Wilk's test, Chi-squared for categorical comparisons between groups, Kaplan-Meir with the log-rank test for survival analysis were performed. The multivariate analysis was performed using Cox proportional Hazard regression model. Statistically significant differences were defined as a p value <0.05.

Statistical analyses were performed using IBM SPSS, version 23 (IBM Corp., Armonk, N.Y., USA).

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with cervical cancer clinical stage Ib2-IVa
  • Treated with concomitant Chemoradiotherapy

排除标准

  • Rare histologies such gastric type adenocarcinoma, neuroendocrine or clear-cell carcinoma
  • incomplete treatment or not treated with chemoradiotherapy
  • Two primary malignancies
  • Insufficient data for analysis.

结局指标

主要结局

Analyze the clinical and pathological characteristics as prognostic factor of patients with locally advanced cervical cancer.

时间窗: 5 years

Analyze the clinical and pathological characteristics of patients with cervical cancer stages IB2 to IVA as prognostic factor in terms of overall survival.

次要结局

  • Analyze the clinical and pathological characteristics as prognostic factor of patients with locally advanced cervical cancer.(5 years)

研究者

发起方
National Institute of Cancerología
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

David Cantu

Md, PhD

National Institute of Cancerología

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