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Clinical Trials/CTRI/2025/07/091604
CTRI/2025/07/091604
Not yet recruiting
Not Applicable

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

NGSM Institute of Pharmaceutical Sciences1 site in 1 country424 target enrollmentStarted: August 11, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
NGSM Institute of Pharmaceutical Sciences
Enrollment
424
Locations
1
Primary Endpoint
To quantify the extent of diagnostic and treatment delays in colorectal cancer

Overview

Brief Summary

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 85.00 Year(s) (—)
Sex
All

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 8 months

Secondary Outcomes

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

Investigators

Sponsor
NGSM Institute of Pharmaceutical Sciences
Sponsor Class
Other [Academic Institute]
Responsible Party
Principal Investigator
Principal Investigator

Yatin Kumar Sharma

NGSM Institute of Pharmaceutical Sciences

Study Sites (1)

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