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CTRI Number  CTRI/2025/07/091604 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 24/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Retrospective study 
Study Design  Single Arm Study 
Public Title of Study   Why Treatment Delays Matter in Colorectal Cancer? 
Scientific Title of Study   Delay in Colorectal Cancer Management and its Impact on Clinical Outcomes: A Retrospective Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yatin Kumar Sharma 
Designation  PG Student 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Paneer, Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8607031154  
Fax    
Email  yatinvats09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Uday Venkat Mateti 
Designation  Associate Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Paneer, Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8152977460  
Fax    
Email  udayv@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Uday Venkat Mateti 
Designation  Associate Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Paneer, Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8152977460  
Fax    
Email  udayv@nitte.edu.in  
 
Source of Monetary or Material Support  
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Paneer, Deralakatte, Mangaluru, Karnataka 575018 
Justice k S Hegde Charitable Hospital, Deralakatte, Mangaluru, Karnataka 575018 
 
Primary Sponsor  
Name  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Paneer, Deralakatte, Mangaluru, Karnataka 575018 
Type of Sponsor  Other [Academic Institute] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Uday Venkat Mateti  Justice K S Hegde Charitable Hospital  Department of Oncology and Medical Records Department
Dakshina Kannada
KARNATAKA 		 8152977460

udayv@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K639||Disease of intestine, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patients aged 18 years and more and primarily diagnosed with colorectal cancer.
Patients treated with chemotherapy (with or without radiotherapy) 
 
ExclusionCriteria 
Details  Patients with metastatic tumors originating from other primary sites.
Patients treated only with radiotherapy. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To quantify the extent of diagnostic and treatment delays in colorectal cancer  8 months 
 
Secondary Outcome  
Outcome  TimePoints 
Identify the key factors contributing to these delays and its effect on clinical outcomes, including survival, disease progression/recurrence  8 months 
 
Target Sample Size   Total Sample Size="424"
Sample Size from India="424" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.
 
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