| CTRI Number |
CTRI/2024/12/077905 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Genetic testing to treat advanced Oral Cancer |
|
Scientific Title of Study
|
Comprehensive Genomic Profiling of Recurrent / Metastatic Oral Cancer for Personalized Treatment: A Novel Approach to Improve Clinical Outcomes and Affordability |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol Version Number- 2.0 Dated – 03.10.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vanita Noronha |
| Designation |
Professor and Medical oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Centre 2nd floor, 204, Homi bhabha Building, Department of Medical Oncology
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09769328047 |
| Fax |
-- |
| Email |
vanita.noronha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanita Noronha |
| Designation |
Professor and Medical oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Centre 2nd floor, 204, Homi bhabha Building, Department of Medical Oncology
MAHARASHTRA
400012
India |
| Phone |
09769328047 |
| Fax |
-- |
| Email |
vanita.noronha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vanita Noronha |
| Designation |
Professor and Medical oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Centre 2nd floor, 204, Homi bhabha Building, Department of Medical Oncology
MAHARASHTRA
400012
India |
| Phone |
09769328047 |
| Fax |
-- |
| Email |
vanita.noronha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Indian Council of Medical Research, V. Ramalingaswami Bhawan, PO Box No. 4911 Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akhil Kapoor |
Mahamana Pandit Madan Mohan Malviya Cancer Centre (MPMMCC) |
OPD no.28, Ground floor, Sundar Bagiya Colony, Sundarpur 221005
Varanasi
UTTAR PRADESH |
09950482121
kapoorakhil1987@gmail.com |
| Dr Vanita Noronha |
Tata Memorial Centre |
Dept of Medical Oncology
OPD 204 Homi Bhabha Block Dr. E. Borges Road Parel Mumbai 400012
Mumbai
MAHARASHTRA |
09769328047
vanita.noronha@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE (IEC), MPMMCC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C000||Malignant neoplasm of external upper lip, (2) ICD-10 Condition: C001||Malignant neoplasm of external lower lip, (3) ICD-10 Condition: C002||Malignant neoplasm of external lip, unspecified, (4) ICD-10 Condition: C003||Malignant neoplasm of upper lip, inner aspect, (5) ICD-10 Condition: C004||Malignant neoplasm of lower lip, inner aspect, (6) ICD-10 Condition: C005||Malignant neoplasm of lip, unspecified, inner aspect, (7) ICD-10 Condition: C006||Malignant neoplasm of commissure of lip, unspecified, (8) ICD-10 Condition: C008||Malignant neoplasm of overlappingsites of lip, (9) ICD-10 Condition: C009||Malignant neoplasm of lip, unspecified, (10) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (11) ICD-10 Condition: C020||Malignant neoplasm of dorsal surface of tongue, (12) ICD-10 Condition: C021||Malignant neoplasm of border of tongue, (13) ICD-10 Condition: C022||Malignant neoplasm of ventral surface of tongue, (14) ICD-10 Condition: C024||Malignant neoplasm of lingual tonsil, (15) ICD-10 Condition: C028||Malignant neoplasm of overlappingsites of tongue, (16) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified, (17) ICD-10 Condition: C030||Malignant neoplasm of upper gum, (18) ICD-10 Condition: C031||Malignant neoplasm of lower gum, (19) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (20) ICD-10 Condition: C040||Malignant neoplasm of anterior floor of mouth, (21) ICD-10 Condition: C041||Malignant neoplasm of lateral floor of mouth, (22) ICD-10 Condition: C048||Malignant neoplasm of overlappingsites of floor of mouth, (23) ICD-10 Condition: C049||Malignant neoplasm of floor of mouth, unspecified, (24) ICD-10 Condition: C050||Malignant neoplasm of hard palate, (25) ICD-10 Condition: C051||Malignant neoplasm of soft palate, (26) ICD-10 Condition: C052||Malignant neoplasm of uvula, (27) ICD-10 Condition: C058||Malignant neoplasm of overlappingsites of palate, (28) ICD-10 Condition: C059||Malignant neoplasm of palate, unspecified, (29) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, (30) ICD-10 Condition: C061||Malignant neoplasm of vestibule ofmouth, (31) ICD-10 Condition: C062||Malignant neoplasm of retromolar area, (32) ICD-10 Condition: C068||Malignant neoplasm of overlappingsites of other and unspecified parts of mouth, (33) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, (34) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients must have recurrent or metastatic oral cancer at the time of diagnosis and must not have undergone any prior treatment.
2. Ability to follow study procedures, including regular follow-ups and assessments, with signed informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Patients who have already received palliative systemic chemotherapy for oral cancer will be excluded.
2. Severe allergies to drugs in the TMC-I regimen.
3. Significant cardiovascular issues like stroke, heart attack, or serious arrhythmias requiring medication.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Identification of response / resistance markers in TMC-I treated oral cancer patients using WES and RNA-sequencing and their correlation with treatment outcomes.
2. Validation of identified genomic alterations on a larger cohort of patient samples to confirm the results.
|
For objective 1, 50 patient samples will be collected retrospectively for 6 months followed by data analysis and gene panel development.
For objective 2, 198 patient samples will be collected prospectively for 1.5 years (6th to 18th month of the study), followed by data analysis and interpretation.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Understanding disease biology and resistance mechanisms by longitudinal monitoring of the identified alterations over time using liquid biopsy (ctDNA) approach. |
For this objective, 50 patients from the earlier 198 patients will be selected prospectively and their samples collected every 3-4 months for 1.5 to 2 years, for sequencing using ctDNA approach, followed by data analysis and interpretation. |
|
|
Target Sample Size
|
Total Sample Size="248"
Sample Size from India="248"
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)
|
20/12/2024 |
| 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="3"
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
|
Rationale/ gaps in existing knowledge: Oral cancer (OC), a major health concern globally, particularly in India, is often diagnosed at advanced stages. Despite understanding its epidemiology and pathogenesis, survival rates remain dismal and effective molecular biomarkers are unintelligible, limiting accessible and tolerable treatment options, especially in Low Middle Income Countries. Tata Memorial Hospital has developed an affordable and effective regimen combining low-dose immunotherapy with metronomic chemotherapy (TMC-I), with improved overall survival. Understanding genomic profile of Indian oral cancer patients is crucial for identifying novel biomarkers predictive of treatment response and prognosis. Novelty: This study proposes to use comprehensive genomic profiling, specifically targeted exome, Whole Exome Sequencing (WES) and RNA-seq to predict treatment responses in oral cancer patients for personalized treatments and selecting appropriate patients for TMC-I, while sparing toxicities in non-responders. Objectives: To identify genetic alterations in Indian oral cancer patients receiving TMC-I, correlate these alterations with treatment outcomes, validate them on a larger patient cohort, and longitudinally monitor them over time using liquid biopsy (ctDNA) approach to understand disease biology and resistance mechanisms. Methods: WES and RNA-sequencing will be performed on baseline tumour samples from TMC-I-treated patients. Genetic profiles so obtained will be correlated with clinical outcomes to identify response and resistance markers. Targeted sequencing on baseline tumour and blood samples from treatment-naive patients will validate these findings. Longitudinal monitoring using liquid biopsy will track genetic changes during treatment. Expected outcome: This study aims to develop a tool for personalized oral cancer treatment, selecting patients for low-dose immunotherapy and chemotherapy based on individual responses. This approach may enhance survival, quality of life, overall health, and improve clinical outcomes in patients with oral cancer in India and globally. |