Oral Potentially Malignant LesionsCYFRA21-1NCT03686020
Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)
An observational study of Oral Potentially Malignant Lesions and Oral Cancer, run by Cairo University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oral Potentially Malignant Lesions, Oral Cancer
- What is being tested?
- Enzyme Linked Immunosorbent assay (ELISA)
- Type of treatment
- Pill or oral medicine
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Oct 2018to Dec 2019
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Egyptian population
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Basma A Zakaria contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Salsabeel Ali Mahmoud, MD, 01222343488, salsabeel_ali@hotmail.com
About this study
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
- Oral Potentially Malignant Lesions, Oral Cancer
- Being tested
- Enzyme Linked Immunosorbent assay (ELISA)
- Keywords
- Oral potentially malignant lesions, Oral cancer, salivary CYFRA21-1, serum CYFRA21-1
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzyme Linked Immunosorbent assay (ELISA)Diagnostic test
measure serum and salivary CYFRA21-1 levels in all included participants using Enzyme Linked Immunosorbent assay (ELISA)
| Study group | Role | What they receive |
|---|---|---|
| Group I | participants suffering from oral potentially malignant lesions Receives: Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA) | |
| Group II | participants suffering from diagnosed oral malignant lesions Receives: Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA) | |
| Group III | healthy participants who are systemically free, non-smokers, and not suffering from any oral mucosal lesions. Receives: Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start23 Oct 2018
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Oral Potentially Malignant LesionsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salsabeel Ali Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686020
- Sponsor's protocol ID
- 1152014
- Acronym
- CYFRA21-1
- Status last verified
- Jul 2019
- First submitted
- 24 Sep 2018
- Last updated
- 23 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24304502Alkotyfan 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.
PubMed 20651382Awasthi 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.
PubMed 29323056Gualtero 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.
PubMed 26577643Malhotra 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.
PubMed 26779624Mortazavi 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.
PubMed 25024833Wang 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.
PubMed 24065233