Clinical trial · Observational
Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)
NCT03686020CI-TRIAL-00039643CYFRA21-1unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oral Potentially Malignant Lesions | Oral Cavity Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enzyme Linked Immunosorbent assay (ELISA) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Group I
- description
- participants suffering from oral potentially malignant lesions
- interventionNames
- Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)
- label
- Group II
- description
- participants suffering from diagnosed oral malignant lesions
- interventionNames
- Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)
- label
- Group III
- description
- healthy participants who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.
- interventionNames
- Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDRajkumar 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. PMID 24304502
- BACKGROUNDAlkotyfan K, Wiegand S, Muller 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. PMID 20651382
- BACKGROUNDAwasthi 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. PMID 29323056
- BACKGROUNDGualtero 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. PMID 26577643
- BACKGROUNDMalhotra 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. PMID 26779624
- BACKGROUNDMortazavi 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. PMID 25024833
- BACKGROUNDWang 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. PMID 24065233