| CTRI Number |
CTRI/2018/05/014222 [Registered on: 30/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
27/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prognostic prediction of head and neck squamous cell carcinomas with clinico-pathological parameters and Epidermal growth factor receptors expression status |
|
Scientific Title of Study
|
Evaluation of clinico-pathological parameters and epidermal growth factor receptors expression status and design a mathematical model for prognosis of oral squamous cell carcinoma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MOHAMMAD AKHEEL |
| Designation |
PHD STUDENT |
| Affiliation |
GREATER KAILASH HOSPITAL |
| Address |
GREATER KAILASH HOSPITAL
OPD NO 5
OLD PALASIA , INDORE
Indore
MADHYA PRADESH
452008
India |
| Phone |
09584284566 |
| Fax |
09584284566 |
| Email |
drakheelomfs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RINKU GEORGE |
| Designation |
HOD, MAXILLOFACIAL ONCOLOGY & RECONSTRUCTION |
| Affiliation |
SAVEETHA UNIVERSITY |
| Address |
SAVEETHA UNIVERSITY
162, Poonamallee High Road, Chennai 600077 India
Chennai
TAMIL NADU
600077
India |
| Phone |
9840069419 |
| Fax |
|
| Email |
rinkugeorge@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MOHAMMAD AKHEEL |
| Designation |
PHD STUDENT |
| Affiliation |
SAVEETHA UNIVERSITY |
| Address |
Greater kailash hospitals
Indore
Indore
MADHYA PRADESH
452008
India |
| Phone |
9584284566 |
| Fax |
09584284566 |
| Email |
drakheelomfs@gmail.com |
|
|
Source of Monetary or Material Support
|
| PRIVATE PATIENTS
GREATER KAILASH HOSPITALS
OPD NO 5
OLD PALASIA , INDORE 452008 |
|
|
Primary Sponsor
|
| Name |
MOHAMMAD AKHEEL |
| Address |
CARE-N-CURE CLINIC
111, CHETAK CENTRE, BESIDE HOTEL SHREEMAYA
INDORE |
| Type of Sponsor |
Other [SELF] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MOHAMMAD AKHEEL |
GREATER KAILASH HOSPITAL |
OPD NO 5 , DEPT OF HEAD & NECK CANCER
OLD PALASIA, INDORE
Indore
MADHYA PRADESH |
9584284566
drakheelomfs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAVEETHA DENTAL COLLEGE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, Medically fit for surgery, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients with squamous cell carcinomas of oral cavity
2. Fungating/non-fungating tumor mass
|
|
| ExclusionCriteria |
| Details |
1.Any previous treatment(Surgery/chemo-radiation)
2. Sarcomas/melanomas/ basal cell carcinomas of head and neck.
3.Recurrence cases
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find whether there is association of EGFR and clinico-pathological factors with prognosis
To find whether the model created helps us to find the prognosis |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find prognosis of patients |
2 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2017 |
| Date of Study Completion (India) |
03/06/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Surgical margins and nodal metastasis are prognostic factors in oral squamous cell carcinoma – A Meta-analysis
2. 2. Depth of tumor infiltration as a prognosticator in pT1-2 N0 oral squamous cell carcinoma and thereby elective neck dissection – A Meta-analysis
3. TO EVALUATE WHETHER EPIDERMAL GROWTH FACTOR RECEPTOR IS AN INDEPENDENT PROGNOSTIC MARKER IN ORAL SQUAMOUS CELL CARCINOMA – A prospective cohort study
4. Influence of histopathological parameters like tumor margins, tumor depth, PNI and lymph nodes in prognosis of oral squamous cell carcinoma- A prospective study with 2 year follow up
5. ASSOCIATION OF SURGICAL MARGINS AND PATHOLOGICAL STAGING WITH EPIDERMAL GROWTH FACTOR RECEPTOR EXPRESSION IN ORAL SQUAMOUS CELL CARCINOMA- A prospective cohort study
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The main background of this research is to 1. To find the prognosis of patient based on clinico-pathological parameters. ( pTNM staging, histological differentiation of tumor, depth of tumor, tumor margins, lymphovascular invasion, perineural invasion, anatomic location) 2. To check whether EGFR as an independant prognostic marker in SCC 3. Association of EGFR expression status with clinico-pathological parameters. |