| CTRI Number |
CTRI/2025/06/089605 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative Cross Sectional study |
| Study Design |
Other |
|
Public Title of Study
|
Measurement and assessment of biomarkers in patients with Oral Squamous Cell Carcinoma in cancer hospital in northern India : an observational study |
|
Scientific Title of Study
|
Evaluation of biomarkers in patients with Oral Squamous Cell Carcinoma attending a tertiary care cancer setting in northern India: An Observational 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 |
Priyanka Asia |
| Designation |
Associate Professor |
| Affiliation |
Homi Bhabha Cancer Hospital , VaranasiHomi Bhabha Cancer Hospital , Varanasi |
| Address |
Department of Biochemistry, 3rd Floor, DNT Block, Mahamana Pandit Madan Mohan Malaviya Cancer Centre , Banaras Hindu University Campus, Sundar Bagiya colony , Sundarpur , Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9423687349 |
| Fax |
|
| Email |
priyanka1asia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shraddha Kailani |
| Designation |
Junior Resident |
| Affiliation |
Homi Bhabha Cancer Hospital , Varanasi |
| Address |
Department of Biochemistry, 3rd Floor, DNT Block, Mahamana Pandit Madan Mohan Malaviya Cancer Centre , Banaras Hindu University Campus, Sundar Bagiya colony , Sundarpur , Varanasi .
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7891219333 |
| Fax |
|
| Email |
shraddhakailani01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Asia |
| Designation |
Associate Professor |
| Affiliation |
Homi Bhabha Cancer Hospital , Varanasi |
| Address |
Department of Biochemistry, 3rd Floor, DNT Block, Mahamana Pandit Madan Mohan Malaviya Cancer Centre , Banaras Hindu University Campus, Sundar Bagiya colony , Sundarpur , Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9423687349 |
| Fax |
|
| Email |
priyanka1asia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahamana Pandit Madan Mohan Malviya Cancer Centre , Banaras Hindu University Campus, Sunder Bagiya colony , Sundarpur , Varanasi , Uttar Pradesh 221005 |
|
|
Primary Sponsor
|
| Name |
Mahamana Pandit Madan Mohan Malviya Cancer Centre |
| Address |
Mahamana Pandit Madan Mohan Malviya Cancer Centre , Banaras Hindu University Campus, Sunder Bagiya colony , Sundarpur , Varanasi , Uttar Pradesh 221005 |
| 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 |
| Dr Priyanka Asia |
Mahamana Pandit Madan Mohan Malviya Cancer Centre |
Department of Biochemistry, 3rd Floor DNT BLock, Clinical Biochemistry Laboratory. Varanasi
Varanasi
UTTAR PRADESH |
9423687349
priyanka1asia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahamana Pandit Madan Mohan Malviya Cancer Centre and HBCH, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently healthy individuals with no history of malignant, metabolic or autoimmune disorders. |
| 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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Histologically proven, newly diagnosed cases of
Oral Squamous Cell Carcinoma
2 Patients between age 18-70 years.
3 Patient willing to give consent.
Eligibility criteria for healthy subjects : Healthy individuals between 18-70 years, with no history of malignant, metabolic or autoimmune disorders who are willing to give consent.
|
|
| ExclusionCriteria |
| Details |
1 Patient not willing to give consent
2 Critically ill patient
3 Pregnant and lactating women
4 Patient with malignancies other than oral
squamous cell carcinoma.
5 Patients with known autoimmune disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)The mean serum levels of CYFRA 21-1, IL-8 and MCP-1 will be measured in OSCC patients vs. healthy subjects . |
All enrolled participants will be assessed at baseline for the outcomes after sample collection of all participants. There is no follow up in the study. Sample will be collected only once and biomarkers estimated and assessed for outcome. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)The distribution of levels of CYFRA 21-1, IL-8 & MCP-1 will be assessed with AJCC PROGNOSTIC STAGE GROUPS (TNM classification) & histopathological staging
2)The distribution of levels of CYFRA 21-1, IL-8 & MCP-1 will be correlated with AJCC PROGNOSTIC STAGE GROUPS (TNM classification) & with histopathological staging.
|
All enrolled participants will be assessed for the outcomes at baseline after sample processing & data compilation of all participants . No follow up will be done. |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
27/08/2025 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response (Others) - Published data will be available in the form of thesis
- For what types of analyses will this data be available?
Response (Others) - NIL
- By what mechanism will data be made available?
Response (Others) - Publication
- For how long will this data be available start date provided 27-02-2027 and end date provided 27-02-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Oral squamous cell carcinoma (OSCC) is the predominant type of cancer found in the oral cavity. CYFRA 21-1,a soluble fragment derived from Cytokeratin 19 is found in the blood. Elevation of CYFRA 21-1 in oral cancers has shown potential as a diagnostic and prognostic indicator . CYFRA 21-1 may be useful in monitoring treatment response and identifying early signs of relapse in various cancers.Interleukin-8 (IL-8), a CXC chemokine is a pro inflammatory and proangiogenic cytokine acting through CXCR1 and CXCR2 receptors. It also promotes cancer cell proliferation and metastasis .Few studies have observed elevated IL-8 levels in serum and various body fluids of cancer patients. Monocyte chemoattractant protein-1 (MCP-1), also known as CCL2, is a C-C chemokine that plays a pivotal role in inflammation and tumor progression .Elevated MCP-1 levels are associated with poor prognosis in various cancers due to its pro-tumor and immunosuppressive effects This study aims to evaluate levels CYFRA 21-1, IL-8, MCP-1 in serum of OSCC patients and explore their correlation with disease status and clinicopathological factors. This study is single centered Comparative cross-sectional study with total sample size of 114 participants divided into 2 groups- 57 OSCC patients and 57 healthy subjects. Sample collection will be done after proper consent of the participants who are eligible according to inclusion criteria. |