| CTRI Number |
CTRI/2024/07/070917 [Registered on: 19/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Genetic study of PD-L1 and CD8 in patients of oral squamous cell carcinoma |
|
Scientific Title of Study
|
Expression of Programmed Death -Ligand 1 (PD-L1) and CD8 in oral squamous cell carcinoma and its association with clinicopathological parameters |
| 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 Pragya Nandini |
| Designation |
Post Graduate |
| Affiliation |
Maulana Azad Medical college |
| Address |
Room no. 54, Department of Pathology, Pathology Block, Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg
Central
DELHI
110002
India |
| Phone |
7651848404 |
| Fax |
|
| Email |
pragyanandini998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varuna Mallya |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 54, Department of Pathology, Pathology Block, Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg
Central
DELHI
110002
India |
| Phone |
9599966089 |
| Fax |
|
| Email |
varunamallya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varuna Mallya |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 54, Department of Pathology, Pathology Block, Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg
Central
DELHI
110002
India |
| Phone |
9599966089 |
| Fax |
|
| Email |
varunamallya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana azad medical college, 2 Bahadur Shah Zafar Marg, New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2, Bahadur 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 Pragya Nandini |
Maulana Azad Medical college |
Room no. 54, Department of Pathology, Pathology block,Maulana Azad Medical college, 2 Bahadur Shah Zafar Marg, New Delhi 110002
Central
DELHI |
7651848404
pragyanandini998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical college and Associated hospital (Lok Nayak, G.I.P.M.E.R.,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: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (2) ICD-10 Condition: C068||Malignant neoplasm of overlappingsites of other and unspecified parts of mouth, (3) ICD-10 Condition: C048||Malignant neoplasm of overlappingsites of floor of mouth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) All the newly diagnosed cases of primary oral squamous cell carcinoma whose samples are received in the Department of Pathology,MAMC
2) Age more than 18 years |
|
| ExclusionCriteria |
| Details |
1)Patients who have received radiotherapy and/or chemotherapy.
2) Patients having previous history of any other malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of cases of oral squamous cell carcinoma showing PD-L1 and CD8 expression |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between expression of PD-L1 and CD8 with clinicopathological parameters like age, Sex, duration of symptoms, tumor size, location, grade, stage, metastasis, lympho-vascular invasion, perineural invasion. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/08/2024 |
| 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 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 - NO
|
|
Brief Summary
|
Oral cancers constitute roughly one-fourth of global occurrences. Most common histological subtype is oral squamous cell carcinoma. PD-L1 is expressed on antigen presenting cells , it causes T cell to undergo apoptosis, so PD-L1 binding to PD-L1 receptors on T cells can suppress antitumor immune responses. Tumor grade and prognosis are associated with PD-L1 expression. Tumor infiltrating CD8+lymphocytes (TILs), play a role in the host’s immunological response to Tumor cells. There is paucity of studies in Indian literature on the expression of Programmed Death Ligand (PD-L1) and CD8 in oral squamous cell carcinoma and its association with clinicopathological parameters. |