| CTRI Number |
CTRI/2025/07/091571 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
case control and cohort study |
| Study Design |
Other |
|
Public Title of Study
|
"Creating prediction tools to help understand and manage patients with mouth cancer risks and outcomes"
|
|
Scientific Title of Study
|
Development and Validation of Predictive Nomograms for Clinical Application in 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 |
Vasantha MN |
| Designation |
PhD Scholar |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Dept of Head and Neck Surgery, Kasturba Medical College, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7899650659 |
| Fax |
|
| Email |
vasantha.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Devaraja K |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College and Hospital, Manipal |
| Address |
Dept of Head and Neck Surgery, Kasturba Medical College, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9999662597 |
| Fax |
|
| Email |
devaraja.k@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Vasantha MN |
| Designation |
PhD Scholar |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Dept of Head and Neck Surgery, Kasturba Medical College, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7899650659 |
| Fax |
|
| Email |
vasantha.kmcmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital,Dept of Head and Neck Surgery, Kasturba Medical College, MAHE, MAnipal-576104, Udupi, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Dept of Head and Neck Surgery, Kasturba Medical College, MAHE, MAnipal-576104, Udupi, Karnataka, India. |
| 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 |
| Vasantha MN |
Dept of Head and Neck Surgery |
Kasturba Medical College, MAHE,Manipal
Udupi
KARNATAKA |
7899650659
vasantha.kmcmpl2024@learner.manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college, Kasturba Hospital, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C020||Malignant neoplasm of dorsal surface of tongue, (2) ICD-10 Condition: C030||Malignant neoplasm of upper gum, (3) ICD-10 Condition: C031||Malignant neoplasm of lower gum, (4) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (5) ICD-10 Condition: C040||Malignant neoplasm of anterior floor of mouth, (6) ICD-10 Condition: C041||Malignant neoplasm of lateral floor of mouth, (7) ICD-10 Condition: C048||Malignant neoplasm of overlappingsites of floor of mouth, (8) ICD-10 Condition: C049||Malignant neoplasm of floor of mouth, unspecified, (9) ICD-10 Condition: C050||Malignant neoplasm of hard palate, (10) ICD-10 Condition: C058||Malignant neoplasm of overlappingsites of palate, (11) ICD-10 Condition: C059||Malignant neoplasm of palate, unspecified, (12) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (13) ICD-10 Condition: C062||Malignant neoplasm of retromolar area, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1)Biopsy proven cancers involving oral cavity (ICD 10- C02, C03, C04, C05, C06)
2)Any T(T1-4) and any N(N1-3), with M0 (non-metastatic)
3) Undergone curative intent treatment at Kasturba Hospital, Manipal
4)Controls (for objective 1): Age and gender matched healthy subjects |
|
| ExclusionCriteria |
| Details |
1)Multiple primary cancers
2)Recurrent cancers
3)Incomplete medical re |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| All-cause mortality |
2 years and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="526"
Sample Size from India="526"
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)
|
01/09/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
Modification(s)
|
This study is a prospective longitudinal study. The primary aim of our study is to develop and validate Nomograms for predicting 1) Carcinogenesis 2) lymph node metastasis and 3) survival outcomes using demographic data, clinical variables, pathological characteristics, as well as nutritional and inflammatory markers, as applicable. |