| CTRI Number |
CTRI/2025/03/081546 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
CXCR-4 and CD 133 Expression and Their Links to Prognosis in Oral Cancer |
|
Scientific Title of Study
|
Expression of C-X-C Chemokine Receptor-4 (CXCR-4) and Cluster of Differentiation 133 (CD 133)
and its correlation with prognostic pathologic factors m resectable oral squamous cell carcinoma. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nirlipta Swain |
| Designation |
PG student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (DMIHER) |
| Address |
Department of Pathology, Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha, Maharashtra.
Wardha
MAHARASHTRA
442107
India |
| Phone |
8895249101 |
| Fax |
|
| Email |
nirliptaswain16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arvind Bhake |
| Designation |
Director Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Reserch (DMIHER) |
| Address |
Department of Pathology, Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha, Maharashtra.
Wardha
MAHARASHTRA
442107
India |
| Phone |
9822684255 |
| Fax |
|
| Email |
aravani@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nirlipta Swain |
| Designation |
PG student |
| Affiliation |
Datta Meghe Institute of Higher Education and Reserch (DMIHER) |
| Address |
Department of Pathology, Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha, Maharashtra.
Wardha
MAHARASHTRA
442107
India |
| Phone |
8895249101 |
| Fax |
|
| Email |
nirliptaswain16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Reserch (DMIHER), Sawangi (Meghe), Wardha, Mahrashtra-442107 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research (DMIHER) |
| Address |
Datta Meghe Institute of Higher Education and Research (DMIHER),Sawangi, Wardha, Maharashtra 442107 |
| 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 Nirlipta Swain |
Acharya Vinoba Bhave Rural Hospital campus |
Department of Oral surgery, Siddharth Gupta Memorial Cancer Hospital, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research (DMIHER), Wardha
Wardha
MAHARASHTRA |
8895249101
nirliptaswain16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K132||Leukoplakia and other disturbancesof oral epithelium, including tongue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
i. Cases diagnosed as OSCC of all three Broders grade on biopsy irrespective of gender and age.
ii. The patients whose surgical specimen is resected and submitted for histopathological examination, to surgical pathology section of Department of Pathology, JNMC, irrespective of surgery type.
|
|
| ExclusionCriteria |
| Details |
i. The patients with inadequate clinical records.
ii. The patients undergoing resection surgery for recurrent tumors of squamous cell carcinoma.
iii. The patients who receive pre- operative chemotherapy or any other monoclonal antibody treatment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study investigates the expression of CXCR-4 and CD 133 in oral squamous cell carcinoma (OSCC) tumor cells and examines their correlation with tumor grade, T stage, N stage, and overall TNM stage. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
17/06/2026 |
| 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="2"
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
|
Background Oral Squamous Cell Carcinoma (OSCC) is a major health issue in India. The metastatic disease and local invasion of it adds to the gravity of morbidity and mortality. Past half a decade has bought out the publications on predictive immunoexpressions for tumor cell motility and tumor cell embolization. There are a few molecules which when expressed were found to be associated with wide metastatic disease of OSCC. Expression of CXC Chemokine Receptor 4 and CD 133 by now are the focus of research in OSCC as implied indicators of invasion and metastasis. Therefore a study is planned with following objectives- The immunoprofiling of tumor cells of OSCC for CXCR- 4 and CD 133. To find association of CXC4- 4 and CD 133 expression of OSCC with tumor grade, T stage, N stage, M stage and TNM stage. Research Question Do the expression of CXCR- 4 and CD 133 correlates with pathologic and prognostic factors. Methodology The study is an observational, cohort study conducted over a period of two years at Jawaharlal Nehru Medical College with cooperation from Siddharth Gupta Memorial Cancer Hospital under Acharya Vinoba Bhave Rural Hospital. The sample size is 75 which is calculated using Danial formula. It will include patients who have diagnosed with oral squamous cell carcinoma on all three Broder’s grade. The patients need to satisfy the specified inclusion and exclusion criteria. Tissue sections will be processed using standard methods. These sections will undergo Hematoxylin and Eosin staining following established procedures. Additionally, immunohistochemistry will be performed using commercially available CXCR-4 and CD 133 on the tumor sections using standard protocols. The presence of brown granules with cytoplasmic positivity will be evaluated, and intensity scores will be assigned. Immunohistochemistry positivity will be assessed specifically in the tumor cells. The statistical analysis will be performed using SPSS software employing methods such as Student’s T test and Chi square test. Conclusion A conclusion will be drawn from the immunohistochemistry study results using CXCR-4 and CD 133 for detecting their immunoexpression and to correlate with tumor grade and TNM stage to determine the prognosis of the disease in resectable oral squamous cell carcinoma. |