| 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
|
|
|
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
|
|
|
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-Ã -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. |