| CTRI Number |
CTRI/2024/05/066689 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the molecular pathway of colorectal carcinoma, and its association with expression of other markers |
|
Scientific Title of Study
|
Microsatellite instability in colorectal carcinoma, and its association with Programmed Cell Death Ligand 1 (PD-L1) expression |
| 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 Muhammed Yaseen O P |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 52, Department of Pathology, Pathology block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi - 110002
Central
DELHI
110002
India |
| Phone |
9745658983 |
| Fax |
|
| Email |
muhammedyaseen888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nita Khurana |
| Designation |
Director Professor and Head |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pathology, Pathology block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi - 110002
Central
DELHI
110002
India |
| Phone |
9968604289 |
| Fax |
|
| Email |
nitakhurana1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nita Khurana |
| Designation |
Director Professor and Head |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pathology, Pathology block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi - 110002
Central
DELHI
110002
India |
| Phone |
9968604289 |
| Fax |
|
| Email |
nitakhurana1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi - 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Bahadu Shah Zafar Marg, New Delhi - 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Muhammed Yaseen O P |
Maulana Azad Medical College |
Department of Pathology, Pathology block, Bahadur Shah Zafar Marg, New Delhi - 110002
Central
DELHI |
9745658983
muhammedyaseen888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospitals (Lok Nayak, G. B Pant Institute of Post Graduate Medical Education (GIPMER) and Research Hospital, Guru Nanak Eye Centre, New Delhi - 110002) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed and Histologically confirmed cases of colorectal carcinoma |
|
| ExclusionCriteria |
| Details |
Patients who have recieved prior chemotherapy/immunotherapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Proportion of cases of colorectal carcinoma with deficient mismatch repair (dMMR).
2.Proportion of cases of colorectal carcinoma showing PD-L1 expression |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Association of MSI status and immunohistochemical expression of PD-L1 with clinicopathological parameters |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/05/2024 |
| Date of Study Completion (India) |
23/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
23/08/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Colorectal carcinoma is one among the leading cause of cancer related deaths around the globe. Molecular heterogeneity plays an important role in predicting the prognosis and treatment outcome in patients with colorectal carcinoma, and to predict the feasibility of novel methods of anticancer therapy, hence becoming a potential subject for exploration and research. This study is a cross sectional observation study on Microsatellite instability in colorectal carcinoma and it’s association with programmed cell death ligand 1 (PD-L1) expression that will be conducted in Department of pathology, Maulana azad medical college, New Delhi, India. The primary outcome measures will be proportion of cases of colorectal carcinoma with deficient mismatch repair (dMMR) and those showing PD-L1 expression. The secondary outcomes will be association of MSI status with clinicopathological parameters.
The reporting magnitude of colorectal carcinoma among the population and its update is very important in country like India with a population of morethan 1.4 billion. |