Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)

Oral Cancer Clinical Trial

— CYFRA21-1  

Official title:

Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03686020
• Other study ID #: 1152014
• Status: Recruiting
• Start date: October 23, 2018
• Est. completion date: December 2019

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: Salsabeel A Mahmoud
• Phone: 00201222343488
• Email: salsabeel_ali[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study is designed to measure serum and salivary CYFRA21-1 levels using enzyme linked immunosorbent assay (ELISA) in patients with oral malignancy, oral potentially malignant lesions, and control subjects to evaluate the potential of CYFRA21-1 as a diagnostic marker for malignant transformation in potentially malignant oral mucosal lesions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

participants will be divided into 3 groups:

• Group I: patients suffering from oral potentially malignant lesions (PML) as defined by World Health Organization.

• Group II: patients suffering from diagnosed oral malignant lesions

• Group III: healthy subjects who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.

Exclusion Criteria:

• Subjects taking any drugs inducing any changes that could affect the salivary flow.

• Pregnant females.

• Subjects have any allergies, infectious diseases or active dental abscesses during one month before saliva sampling.

• Patients receiving any drugs related to the oral lesions in the past 6 month prior to sample collection.

Related Conditions & MeSH terms

• Mouth Neoplasms
• Oral Cancer
• Oral Potentially Malignant Lesions

Intervention

Diagnostic Test:
• Enzyme Linked Immunosorbent assay (ELISA)
measure serum and salivary CYFRA21-1 levels in all included participants using Enzyme Linked Immunosorbent assay (ELISA)

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

Alkotyfan K, Wiegand S, Müller HH, Windfuhr JP, Werner JA, Sesterhenn AM. Cyfra 21-1 as a tumor marker for follow-up of patients with squamous cell carcinoma of the oropharynx. Anticancer Res. 2010 Jun;30(6):2291-6. — View Citation

Awasthi N. Role of salivary biomarkers in early detection of oral squamous cell carcinoma. Indian J Pathol Microbiol. 2017 Oct-Dec;60(4):464-468. doi: 10.4103/IJPM.IJPM_140_16. — View Citation

Gualtero DF, Suarez Castillo A. Biomarkers in saliva for the detection of oral squamous cell carcinoma and their potential use for early diagnosis: a systematic review. Acta Odontol Scand. 2016;74(3):170-7. doi: 10.3109/00016357.2015.1110249. Epub 2015 Nov 18. Review. — View Citation

Malhotra R, Urs AB, Chakravarti A, Kumar S, Gupta VK, Mahajan B. Correlation of Cyfra 21-1 levels in saliva and serum with CK19 mRNA expression in oral squamous cell carcinoma. Tumour Biol. 2016 Jul;37(7):9263-71. doi: 10.1007/s13277-016-4809-4. Epub 2016 Jan 15. — View Citation

Mortazavi H, Baharvand M, Mehdipour M. Oral potentially malignant disorders: an overview of more than 20 entities. J Dent Res Dent Clin Dent Prospects. 2014 Winter;8(1):6-14. doi: 10.5681/joddd.2014.002. Epub 2014 Mar 5. Review. — View Citation

Rajkumar K, Ramya R, Nandhini G, Rajashree P, Ramesh Kumar A, Nirmala Anandan S. Salivary and serum level of CYFRA 21-1 in oral precancer and oral squamous cell carcinoma. Oral Dis. 2015 Jan;21(1):90-6. doi: 10.1111/odi.12216. Epub 2013 Dec 30. — View Citation

Wang YX, Hu D, Yan X. Diagnostic accuracy of Cyfra 21-1 for head and neck squamous cell carcinoma: a meta-analysis. Eur Rev Med Pharmacol Sci. 2013 Sep;17(17):2383-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity and specificity of serum and salivary CYFRA21-1 as a diagnostic marker in oral cancer	diagnostic accuracy in terms of sensitivity and specificity of serum and salivary CYFRA21-1 in differentiating between oral malignancy and oral potential malignant lesions in order to be able to early diagnose malignant changes in oral lesions.	one year