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临床试验/CTRI/2025/07/091604
CTRI/2025/07/091604尚未招募不适用

Delay in Colorectal Cancer Management and its Impact on Clinical Outcomes: A Retrospective Study

NGSM Institute of Pharmaceutical Sciences1 个研究点 分布在 1 个国家目标入组 424 人开始时间: 2025年8月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
424
试验地点
1
主要终点
To quantify the extent of diagnostic and treatment delays in colorectal cancer

研究概览

简要总结

Introduction

According to GLOBOCAN 2022 colorectal cancer (CRC) is the sixth most common malignancy in India, with an incidence rate of 5%, a five-year prevalence of 12.5 per 100,000 populations. It ranks seventh in cancer-related mortality (4.5%). In India, the five-year survival rate for colorectal cancer remains among the lowest globally, at less than 40%.The CONCORDE-2 study has reported a decline in five-year survival rates in certain Indian registries. Delays in diagnosis and treatment—from the onset of symptoms to initiation of therapy—may influence prognosis, overall survival, and disease stage at diagnosis. Thus, we aim to identify the factors associated with delays in treatment and assess the impact on clinical outcomes such as survival, mortality and disease progression/ recurrence.

Need for the study

Colorectal cancer (CRC) survival outcomes remain poor in India. Delays in diagnosis and treatment initiation are recognized as critical factors influencing clinical outcomes. However, there is limited evidence from India on patient related factors responsible for these delays and how these delays affect disease stage at presentation, overall survival, and treatment response. Given these challenges, there is a pressing need to assess the extent of treatment delays in CRC and their impact on clinical outcomes in the Indian population. Understanding these factors can help inform healthcare policies, improve early detection strategies, and optimize treatment timelines, ultimately enhancing clinical outcomes.

Objectives of the study

To identify the factors associated with treatment delays among colorectal cancer patients.

To correlate the identified factors with clinical outcomes in colorectal cancer patients.

Methodology

This study (Retrospective study) will be carried out in the Department of Oncology, Justice K S Hegde Charitable Hospital, Deralakatte, Mangaluru. The target population for this study is all the patients with primary diagnosis of colorectal cancer who have been treated in the last 5 years (2019-2023). Patients primarily diagnosed with colorectal cancer and treated with chemotherapy (with or without radiotherapy) will be included in the study. Patients with metastatic tumors originating from other primary sites and patients treated only with radiotherapy will be excluded from the study with the objectives,  and to correlate the identified factors with clinical outcomes. The duration of the study will be 8 months and data will be analyzed with the help of inferential statistics (chi-square test, Pearson correlation) and descriptive statistics (mean, standard deviations) and using log rank and Kalpan- Meier test and by multivariate COX proportional model and hazard ratio.

Anticipated outcomes

This study is expected to quantify the extent of diagnostic and treatment delays in colorectal cancer (CRC) and identify the key factors contributing to these delays and its effect on clinical outcomes, including survival, mortality and disease progression/ recurrence.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18 years and more and primarily diagnosed with colorectal cancer.
  • Patients treated with chemotherapy (with or without radiotherapy).

排除标准

  • Patients with metastatic tumors originating from other primary sites.
  • Patients treated only with radiotherapy.

结局指标

主要结局

To quantify the extent of diagnostic and treatment delays in colorectal cancer

时间窗: 8 months

次要结局

  • Identify the key factors contributing to these delays and its effect on clinical outcomes, including survival, disease progression/recurrence(8 months)

研究者

发起方
NGSM Institute of Pharmaceutical Sciences
申办方类型
Other [Academic Institute]
责任方
Principal Investigator
主要研究者

Yatin Kumar Sharma

NGSM Institute of Pharmaceutical Sciences

研究点 (1)

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