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CTRI Number  CTRI/2024/02/063324 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 21/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective observational study 
Study Design  Other 
Public Title of Study   Mapping the signet-ring cell in colorectal cancer A spatial epidemiology study in India 
Scientific Title of Study   Mapping the signet-ring cell colorectal cancer epidemic in India – A spatial epidemiology 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  DrAvanish Saklani 
Designation  Professor and Colorectal Suegeon 
Affiliation  Tata memorial hospital 
Address  HBB, 3rd floor, Department of Surgical Oncology tata memorial hospital dr ernest borges marg parel mumbai
HBB, 3rd floor, Department of Surgical Oncology tata memorial hospital dr ernest borges marg parel mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  7400319886  
Fax    
Email  asaklani@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrAvanish Saklani 
Designation  Professor and Colorectal Suegeon 
Affiliation  Tata memorial hospital 
Address  HBB, 3rd floor, Department of Surgical Oncology tata memorial hospital dr ernest borges marg parel mumbai
HBB, 3rd floor, Department of Surgical Oncology tata memorial hospital dr ernest borges marg parel mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  7400319886  
Fax    
Email  asaklani@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Avanish Saklani 
Designation  Professor and Colorectal Suegeon 
Affiliation  Tata memorial hospital 
Address  HBB, 3rd floor, Department of Surgical Oncology tata memorial hospital dr ernest borges marg parel mumbai
HBB, 3rd floor, Department of Surgical Oncology tata memorial hospital dr ernest borges marg parel mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  7400319886  
Fax    
Email  asaklani@hotmail.com  
 
Source of Monetary or Material Support  
Tata memorial hospital,Department of surgical oncology,Dr ernest borges marg parel, mumbai 400012 
 
Primary Sponsor  
Name  Tata memorial hospital 
Address  Tata memorial hospital Parel,Mumbai 400012 
Type of Sponsor  Research institution and hospital 
 
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 Avanish Saklani  Tata Memorial Centre  HBB, 3rd floor, Department of Surgical Oncology tata memorial hospital dr ernest borges marg parel mumbai and ACTREC kharghar Navi mumbai
Mumbai
MAHARASHTRA 
7400319886

asaklani@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata memorial centre Institutional Ethics Committee I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: U07-U07||Provisional assignment of new diseases of uncertain etiology or emergency use,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Not Applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Histologically confirmed adenocarcinomas of the colon and rectum of all age groups and clinical stages. will be included. 
 
ExclusionCriteria 
Details  We will exclude non-adenocarcinoma histologies and tumours metastatic to the colon or the rectum. Also excluded will be peritoneal carcinomatosis from an adenocarcinoma of an unknown primary that are sometimes treated as metastatic colorectal cancers.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measure is the geographic distribution of SRCC in India.
The geographic distribution will be recorded and analyzed
 
2 years 
 
Secondary Outcome  
Outcome  TimePoints 
-Compare SRCC & non-SRCC with respect to location of the primary tumour (Colon vs rectum), paying category (General vs private), Age, Sex, religion.   2 years 
 
Target Sample Size   Total Sample Size="5000"
Sample Size from India="5000" 
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)   05/03/2024 
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="1"
Months="0"
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  

Summary

Title:  Mapping the Signet-Ring Cell Colorectal Cancer Epidemic in India:

Colorectal cancer, a type of cancer that affects the colon or rectum, is a significant global health concern. Within this category, there is a rare and aggressive subtype called "signet-ring cell colorectal cancer." Interestingly, this subtype is more common in India compared to Western countries, and we don’t fully understand why. To address this knowledge gap, a research study called "Mapping the Signet-Ring Cell Colorectal Cancer Epidemic in India – A Spatial Epidemiology Study" will be conducted. In simple terms, this study aims to explore where this cancer is most common in India and try to uncover the reasons behind its higher prevalence in later studies.

Background: What is Colorectal Cancer and Signet-Ring Cell Colorectal Cancer?

Colorectal cancer is one of the most common types of cancer in the world, and it’s a leading cause of cancer-related deaths. Signet-ring cell colorectal cancer is a specific and aggressive type of colorectal cancer. What makes it interesting is that while it’s quite rare worldwide (accounting for only 1% of all colorectal cancers), it’s more common in India, where it makes up 15-20% of colorectal cancer cases.

The Challenge: India’s Diversity and Limited Data

India is a vast and diverse country with a wide range of cultures, lifestyles, and healthcare access. Because of this diversity, cancer rates can vary significantly from one region to another. For example, some types of cancer are more common in certain areas of India, like gall bladder cancer in the Sub-Himalayan areas. So, it’s possible that even within India, the prevalence of signet-ring cell colorectal cancer varies from one region to another. Identifying these high-prevalence regions could help us understand what causes this type of cancer.

The Study Plan: How will the Research be Conducted?

To conduct this study, we will look at the data from Tata Memorial Hospital in Mumbai, India for patients diagnosed with colorectal cancer between 2020 and 2022 and record their place of residence vis-à-vis histological type; and see how many of them had the signet-ring cell subtype and how many had other types of colorectal cancer. Then we will look at region wise differences of signet cancer in the country.

Why is This Study Important?

Understanding the geographical variations in signet-ring cell colorectal cancer in India is crucial for several reasons. First, it could help us identify the factors or causes that lead to this specific type of cancer. Second, it might lead to insights about why this cancer is more common in India compared to other parts of the world. Third, this knowledge could potentially lead to better ways of preventing and treating signet-ring cell colorectal cancer.

Ultimately, this knowledge could contribute to better strategies for preventing and treating signet-ring cell colorectal cancer, potentially saving lives in the future.

 
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