| CTRI Number |
CTRI/2022/04/042224 [Registered on: 27/04/2022] Trial Registered Prospectively |
| Last Modified On: |
27/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical trial to study the clinical and haematological inflammatory parameters in patients treated with oral squamous cell carcinoma |
|
Scientific Title of Study
|
Evaluation of Clinical and Haematological Inflammatory profile in patients treated for oral squamous cell carcinoma- A Prospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chenchulakshmi G |
| Designation |
MDS,Post graduate,Department of Oral Medicine and Radiology |
| Affiliation |
Saveetha dental college |
| Address |
162,Poonamallee High Road,Velappanchavadi,Chennai-600077
162,Poonamallee High Road,Velappanchavadi,Chennai,Tamil Nadu
Chennai
TAMIL NADU
600077
India |
| Phone |
9940643216 |
| Fax |
|
| Email |
g.chenchulakshmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind M |
| Designation |
Professor and Head Of Department of Oral Medicine and Radiology |
| Affiliation |
Saveetha dental College |
| Address |
162,Poonamallee High Road,Velappanchavadi,Chennai-600077
162,Poonamallee High Road,Velappanchavadi,Chennai-600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9444303303 |
| Fax |
|
| Email |
arvindmuthukrishnan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind M |
| Designation |
Professor and Head Of Department of Oral Medicine and Radiology |
| Affiliation |
Saveetha dental College |
| Address |
162,Poonamallee High Road,Velappanchavadi,Chennai-600077
162,Poonamallee High Road,Velappanchavadi,Chennai-600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9444303303 |
| Fax |
|
| Email |
arvindmuthukrishnan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Saveetha dental college
162,Poonamallee High Road,Velappanchavadi,Chennai-600077 |
|
|
Primary Sponsor
|
| Name |
Saveetha dental college |
| Address |
162,Poonamallee High Road,Velappanchavadi,Chennai,Tamil Nadu,600077 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Arvind M |
162,Poonamallee High Road,Velappanchavadi,Chennai,Tamil Nadu,600077 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Chenchulakshmi G |
Saveetha dental college |
Department of Oral Medicine and Radiology and Department of Oral Oncology
Chennai
TAMIL NADU |
9940643216
g.chenchulakshmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients histologically diagnosed with oral squamous cell carcinoma.
2)Patients with untreated oral squamous cell carcinoma scheduled for surgery/radiotherapy/chemotherapy |
|
| ExclusionCriteria |
| Details |
1)Patients with treated oral squamous cell carcinoma
2)Patients with factors that could influence Neutrophil-Lymphocyte ratio,Lymphocyte-Monocyte ratio,Platelet-Lymphocyte ratio such as infections,chronic inflammatory diseases,chronic hematologic diseases and recent treatments with steroids |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the biochemical values of Neutrophil-Lymphocyte ratio,Lymphocyte-Monocyte ratio,Platelet-Lymphocyte ratio with standard values in patients with OSCC and evaluate prognosis. |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the biochemical values of Neutrophil-Lymphocyte ratio,Lymphocyte-Monocyte ratio,Platelet-Lymphocyte ratio with standard values in patients with OSCC at regular intervals of 2 months for 1 year and evaluate prognosis. |
pre op and post op at second,fourth,sixth,eighth,tenth and twelth month |
|
|
Target Sample Size
|
Total Sample Size="49"
Sample Size from India="49"
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)
|
28/04/2022 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Inflammatory process plays a major role in the initiation genesis progression of oral cancer. High levels of inflammatory response would have a poor prognosis on cancer outcomes. Prognostic indicators should be able to predict the disease outcome following treatment in patients with oral squamous cell carcinoma. Haematological inflammatory indicators like neutrophil-lymphocyte ratio, lymphocyte-monocyte ratio, platelet lymphocyte ratio could be used both pre-treatment under regular intervals post treatment- to evaluate and assess the long time prognosis. |