| CTRI Number |
CTRI/2022/03/041256 [Registered on: 22/03/2022] Trial Registered Prospectively |
| Last Modified On: |
27/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of circulating tumour cells in patients with tumour free lymphnodes in oral tongue carcinoma |
|
Scientific Title of Study
|
Evaluation of molecular expression of pre metastatic lymph nodes and to corelate with circulating tumour cells in oral tongue tumours |
| Trial Acronym |
CTC Trail |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajalakshmi G |
| Designation |
Principal Investigator (DHR Funding-Women Scientist Scheme)) |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Head and Neck Oncology(Room 13) ,Tower 1 4th Floor Amrita Institute of Medical Sciences Kochi.
Ernakulam
KERALA
682041
India |
| Phone |
08606469099 |
| Fax |
|
| Email |
drraji14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subramania Iyer |
| Designation |
Professor and Head |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Head and Neck Oncology ,Room no 9 Tower 1 4th floor Amrita Institute of Medical Sciences,Ponekkara Kochi
Ernakulam
KERALA
682041
India |
| Phone |
|
| Fax |
|
| Email |
subu.amrita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajalakshmi |
| Designation |
Research Associate /Principal Investigator (DHR Funding) |
| Affiliation |
|
| Address |
Head and Neck Oncology Room 13, Tower 1 - 4th floor Kochi Amrita Institute of Medical Sciences ,Kochi.
Ernakulam
KERALA
682041
India |
| Phone |
08606469099 |
| Fax |
|
| Email |
drraji14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research, GoI -Grant Technically Approved |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences |
| Address |
Amrita Institute of Medical Sciences Kochi |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Health Research |
Department of Health Reaserch IRCS Building NewDelhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr RajalakshmiG |
Amrita Institute of Medical Sciences |
Amrita Institute of Medical Sciences -Amrita Vishwa Vidhyapeetham Ponekkara Kochi
Ernakulam
KERALA |
8606469099
drraji14@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Amrita Institute of Medical Sciences |
Approved |
| ECASM AIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Tongue Squamous Cell Carcinoma with no previous history of treatment other than diagnostic biopsy. |
|
| ExclusionCriteria |
| Details |
Second Primary Tumours ,Recurrent Tumours |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of circulating tumour cells and to compare with the molecular markers of tumour free lymphnodes |
5ml of peripheral blood to be taken before surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate of circulating tumour cells and corelate with the prognosis of OTSCC patients |
2 year follow up |
|
|
Target Sample Size
|
Total Sample Size="97"
Sample Size from India="97"
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)
|
25/03/2022 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Annual estimated incidence of oral cancer is 2, 75,000 and out of these 2/3rds occurs in the developing countries. In India more than one million new oral cancer cases are being detected annually of which 92% are Oral Squamous Cell Carcinomas (OSCC). Cancers of floor of mouth and tongue constitute about 50 percent of oral cancers in India.It is found that individuals under the age of 35yr with oral cancer (OC) 52% had OTSCC with a higher male preponderance (2.3:1). Added to this were the facts that 40% of these young individuals did not report any abusive habits, had poor quality of life with high morbidity, and increased healthcare and social burden as the lower socio-economic strata were more afflicted. Cancer metastasis has been a scorching topic for its high mortality and recent researches has shown that premetastatic niche and metastatic niche are the 2 crucial steps in cancer metastasis, assisting cancerous cells infiltration, survival, and colonization at target sites.This study focus on the concept of premetastatic niche and considering CTCs as potential metastatic seeds which can form metastatic colonization in future. Study will assign the role of the probability of Circulating Tumor Cells as a real time monitor of tumor evolution. It also guide in developing therapies to prevent or eradicate metastases before reaching an incurable stage. This may substantiate the efficacy of liquid biopsy (CTC) which is a noninvasive method. This study ultimately aims in improving the survival rates and preventing the tumour metastasis . |