Oral Cancer Biomarker Study

Not Applicable

• Conditions: Health Condition 1: C069- Malignant neoplasm of mouth, unspecified

• Registration Number: CTRI/2019/01/017092
• Lead Sponsor: Case Western Reserve university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Consent â?? Subjects must demonstrate understanding of the study procedures as evidenced by voluntary written informed consent and has received a copy of the consent form.

2. Compliance â?? Subjects must be willing, able, and likely to comply with all study procedures and restrictions.

3. Age â?? Subjects must be 18 years of age or older. There are no restrictions on maximum age.

4. Diagnosis â?? Subjects must be currently undergoing clinical evaluation for determination of OSCC diagnosis due to the presence of suspicious red or white lesions, with no prior history of HNC

Lesions >5mm that fill the following requirements:

i. Include non-diagnosed yet suspicious lesions of the subsites above like CIS, T1 and T2 lesions.

ii. Include diagnosed premalignant and early malignant lesions (again CIS, T1 and T2 lesions).

iv. Include superficial lesions like Leukoplakia, Erythroplakia and deeper but common problems.

v. Exclude large Necrotic lesions (clinically advanced cancer T3 and T4) either diagnosed or non-diagnosed cancers in this group as often as possible

Exclusion Criteria

1. Very small Lesions Less than 5 mm in size.

2. T1, T2 Lesions with Necrotic areas.

3. Diagnosis â?? Individuals with Prior diagnosis of any head neck malignancy.

4. Patients with previous or current treatment involving radiation and/or chemotherapy, regardless of cancer type or cancer diagnosis dates, will be excluded.

5. Pregnancy

6. Anything that would place the individual at increased risk or preclude the individualâ??s full compliance with or completion of the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of Human Beta defensin Level in normal mucosa as well as cases of oral cancerTimepoint: 1month from sample collection

Secondary Outcome Measures

Name	Time	Method
correlation Human beta defensin index 2, 3 with histopathology reportTimepoint: after final histopathology report