| CTRI Number |
CTRI/2024/09/073436 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Characteristics of Cancer Patients Tested for micro-satellite gene Errors at a Major Cancer Hospital in Kerala, India |
|
Scientific Title of Study
|
Clinicopathological Characteristics of Cancer Patients Undergoing Mismatch Repair Gene Testing in a Tertiary Cancer Center in Kerala, India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Navya Mathew |
| Designation |
Intern |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Room number 409, Devamatha Annexe ,Amala Institute of Medical Sciences , Amala Nagar , Thrissur ,Kerala
680555
Thrissur
KERALA
680555
India |
| Phone |
9633537823 |
| Fax |
|
| Email |
Navyamathew1512@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwin Oommen Philips |
| Designation |
Associate Professor , Department of Oncology |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Room number 7 ,Department of Medical Oncology, ground floor, Sacred Heart Block, Amala Institute of Medical Sciences, Amalanagar , Thrissur ,Kerala
680555
Thrissur
KERALA
680555
India |
| Phone |
9003635373 |
| Fax |
|
| Email |
drashphilsmog@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwin Oommen Philips |
| Designation |
Associate Professor , Department of Oncology |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Room number 7 ,Department of Medical Oncology, ground floor, Sacred Heart Block, Amala Institute of Medical Sciences, Amalanagar, Thrissur ,Kerala
680555
Thrissur
KERALA
680555
India |
| Phone |
9003635373 |
| Fax |
|
| Email |
drashphilsmog@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amala Institute of Medical Sciences
Amala Nagar
Thrissur
Kerala 680555 |
|
|
Primary Sponsor
|
| Name |
Dr Ashwin Oommen Philips |
| Address |
Room number 7 ,Department of Medical Oncology, ground floor, Sacred Heart Block, Amala Institute of Medical Sciences, Amalanagar , Thrissur , Kerala |
| Type of Sponsor |
Other [Other] |
|
|
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 Ashwin Oommen Philips |
Amala Institute of Medical Sciences |
Room number 7 ,Department of Medical Oncology, ground floor, Sacred Heart Block, Amala Institute of Medical Sciences, Amalanagar
Thrissur
KERALA |
9003635373
drashphilsmog@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AMALA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D490||Neoplasm of unspecified behavior of digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age:All adult cancer patients aged 18 years and above.
MMR Testing: Patients who have undergone MMR testing using Immunohistochemistry (IHC) for MLH1, PMS2, MSH2, and MSH6 proteins.
Cancer Type: Patients diagnosed with any type of solid malignancy, including colorectal, endometrial, ovarian, and other cancers where MMR testing is clinically indicated.
Treatment History: Patients who have completed their primary cancer treatment (surgery, chemotherapy, radiation) and for whom MMR testing was part of the diagnostic or therapeutic decision-making process.
Clinical Data Availability: Patients with complete clinical records, including demographic data, tumor characteristics, treatment details, and MMR test results.
Follow-up Data: Patients with documented follow-up data to assess treatment outcomes, response to therapy, and survival. |
|
| ExclusionCriteria |
| Details |
Pediatric Patients: Patients younger than 18 years of age.
Incomplete Records: Patients with incomplete clinical records, particularly those missing MMR test results or key demographic and tumor-related information.
Non-Solid Tumors: Patients with hematological malignancies or other non-solid tumors that do not typically undergo MMR testing.
No Follow-up Data: Patients with no available follow-up data, making it impossible to assess treatment outcomes and survival. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the prevalence of MSI testing and its outcomes in solid tumours in a tertiary care centre |
0,6,9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Analyze the demographic details of cancer patients on whom Mismatch Repair Gene Testing (MMR) was done at a tertiary cancer center in India.
|
23rdAugust 2024 to 23rd January 2025 |
Assess the frequency and distribution of MMR deficiency among cancer patients in the study population.
|
23rd August 2024 to 23rd January 2025 |
Identify any correlations between MMR status and clinicopathological features, such as age, gender, tumor location, and histological subtype.
|
23rd August 2024 to 23rd January 2025 |
|
|
Target Sample Size
|
Total Sample Size="113"
Sample Size from India="113"
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)
|
14/09/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drashphilsmog@gmail.com].
- For how long will this data be available start date provided 20-08-2024 and end date provided 20-02-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Abstract
Title: Clinicopathological Characteristics of Cancer Patients Undergoing Mismatch Repair Gene Testing in a Tertiary Cancer Center in Kerala, India
Background: DNA damage from various sources can lead to mutations, driving diseases like cancer. The DNA mismatch repair (MMR) pathway is crucial for maintaining genomic integrity by preventing such mutations. MMR deficiency (dMMR) is associated with hereditary cancer syndromes and several sporadic cancers, including colorectal and endometrial cancers. Testing for MMR status via immunohistochemistry (IHC) is common and aids in diagnosing hereditary cancers, guiding therapy, and predicting response to immune checkpoint inhibitors.
Objectives: This study aims to assess the clinicopathological characteristics and outcomes of cancer patients undergoing MMR testing at a tertiary cancer center in Kerala, India. The study will investigate demographic details, the frequency and distribution of MMR deficiency, and correlations between MMR status and clinicopathological features.
Methods: This retrospective observational study will analyze data from January 1, 2018, to June 30, 2024, from the pathology and medical oncology departments of the Amala Institute of Medical Sciences, Thrissur. All cancer patients who underwent MMR testing within this period will be included, except pediatric patients and those with incomplete records. Data on demographics, cancer types, stages, tumor location, histological subtype, and MMR testing results will be extracted and analyzed using descriptive and analytical statistics. Chi-square tests, t-tests, ANOVA, and logistic regression will be employed to assess correlations and predictors of MMR deficiency.
Expected Outcomes: The study aims to enhance diagnostic criteria for MMR testing, optimize treatment strategies, improve clinical decision-making, and identify patterns in MMR-related cancers specific to the local context in Kerala. Insights from this study could contribute to better management of cancer patients with MMR deficiencies.
Ethical Considerations: Institutional ethics committee approval will be obtained, ensuring confidentiality and ethical handling of patient data. Waiver of consent is sought due to the retrospective nature of the study. |