| CTRI Number |
CTRI/2024/07/069961 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
21/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of vitamin D levels in patients with Oral squamous cell carcinoma and potentially malignant lesions |
|
Scientific Title of Study
|
Serum Vitamin D levels in patients with Oral squamous cell carcinoma and potentially malignant lesions - a comparative study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srikanth G |
| Designation |
Professor & Head |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Dept. of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9535619076 |
| Fax |
|
| Email |
srikanth.mds@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Srikanth G |
| Designation |
Professor & Head |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Dept. of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal
KARNATAKA
576104
India |
| Phone |
9535619076 |
| Fax |
|
| Email |
srikanth.mds@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Srikanth G |
| Designation |
Professor & Head |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Dept. of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal
KARNATAKA
576104
India |
| Phone |
9535619076 |
| Fax |
|
| Email |
srikanth.mds@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences, Madhav Nagar, Manipal, Karnataka, India - 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Srikanth G |
| Address |
Dept. of Oral & Maxillofacial surgery, Manipal College of Dental Sciences, Manipal, Karnataka, India - 576104. |
| Type of Sponsor |
Other [Self] |
|
|
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 Srikanth G |
Manipal College of Dental Sciences |
Room no. 4, Dept. of Oral & Maxillofacial Surgery, MCODS, Manipal
Udupi
KARNATAKA |
9986455201
srikanth.mds@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with no suspicion of Oral SCC or premalignant lesion visiting department of oral maxillofacial surgery who expresses their willingness to be part of the study and require Vitamin D assessment as a standard of care.
2. Patients visiting department of oral maxillofacial surgery with histologically diagnosed oral squamous cell cancer or potential malignant lesions. |
|
| ExclusionCriteria |
| Details |
1. Patients with recurrent cancer or already under the treatment.
2. Participants who are under any type of vitamin D supplements/calcium in the last one year. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vitamin D levels in patients with Oral SCC and Oral Potentially malignant lesions |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of histopathological grades of OSCC & Serum vitamin D levels.
2. Comparison of different potentially malignant lesions & Serum vitamin D levels.
3. Inter-group comparison of Vitamin D levels in Group A, B & C |
Baaseline |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
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)
|
05/07/2024 |
| 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 Yet Recruiting |
| 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
|
Vitamin D deficiency is frequently observed in human cancer patients and a prognostic relevance could be shown for some entities. A low serum level of 25-hydroxy vitamin D, the principal form of circulating vitamin D, is the main marker of vitamin D deficiency and is studied to have a potent anti-neoplastic activity in the management of several human malignancies. Few systemic reviews are available which have observed that there exists a relationship between vitamin D and cancerous cells. It’s noted that this works by enhancing anti-proliferation and pro-apoptotic factors, as well as inhibition of cell-cycle promoters and growth factor signalling pathway., thus inhibiting cancer cell proliferation. Thus, Vitamin D is a pro-apoptotic factor and is a useful anti-neoplastic agent. Through this study we aim to validate this correlation and acknowledge the relationship if any between the prevalence of oral squamous cell carcinoma and serum vitamin D levels
Patients presenting to Department of oral maxillofacial surgery with a clinical diagnosis of oral squamous cell carcinoma (Group A) or potentially malignant lesion (Group B) will be included in this study. Cancer free healthy patients who are willing to be part of the study would be included as controls (Group C). Patients in Group A and Group B, as per protocol, require to be biopsied to have confirmatory diagnosis. Prior to biopsy these patients are sent for routine blood tests for evaluation of Complete blood picture, biochemistry analysis like blood glucose, serum electrolyte, etc. and bleeding and clotting time evaluation. During these blood sampling the patient will be asked for additional tests for Vitamin D analysis. Patients in Group C will comprise of patients with no suspected intra-oral lesion, however, undergoing any minor surgical procedure which will require prior blood tests. Informed consent of the patients will be obtained. Information on age, sex, tobacco habit status would be collected. Histopathological differentiation would be recorded from oral squamous cell carcinoma. Type of potentially malignant lesion would also be recorded. |