Salivary Ap4A, SCCA, TROP2 in Oral Cancer Patients
OCSALTM
Isolation, Quantification and Kinetics of Salivary Ap4A, SCCA and TROP2 in Patients With Oral Cancer and Potentially Malignant Oral Disorders
1 other identifier
observational
100
0 countries
N/A
Brief Summary
According to the World Health Organization, oral cancer (OC) is the eighth most common cancer in the world with a five year survival rate of 50%. Oral cancer tumor cells produce biochemical substances, tumor markers, differed from healthy individuals in expression or quantitative ratio, detectable in tissues and/or body fluids. Saliva, because of its accessibility, proximity and noninvasive approach, presents an ideal tool for the research of oral cancer tumor markers. The aim of this study will be to isolate, quantify, analyze the role and describe the kinetics of diadenosine tetraphosphate (Ap4A), Squamous Cell Carcinoma associated Antigen (SCCA), Trophoblast cell surface antigen (TROP2) in patients with OC, potentially malignant disorders (PMOD) and age and sex matched control group with a clear medical history. There are number of studies published on OC tumor markers isolated mostly in serum, however the satisfactory specificity and sensitivity still hasn't been reached. Liquid chromatography-ion trap-mass spectrometry, Multiple Reaction Monitoring method (LC-IT-MS, MRM) will be developed to isolate and quantify the above mentioned tumor markers. This method has not yet been used to quantify the above mentioned salivary tumor markers. Ap4A and TROP2 have never been isolated from saliva. The aim is to develop a tumor-specific test with a satisfactory statistical sensitivity and specificity and dynamically measure the levels of tumor markers, before and immediately after therapy - surgery/radiotherapy/chemotherapy or their combination, and during regular follow-up one and two years after surgery. As another novelty, the investigators aim to determine the markers circadian rhythm. A OC tumor specific test, with satisfactory sensitivity and specificity, would enable earlier OC diagnosis, possibly before the clinical appearance, raise the survival rate of OC patients, enable early diagnosis of recurrence and/or new primary tumors and ensure better post-treatment life-quality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2016
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 7, 2018
CompletedFirst Posted
Study publicly available on registry
May 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedOctober 16, 2018
October 1, 2018
3.9 years
May 7, 2018
October 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Salivary tumor marker levels before surgery
Salivary tumor marker levels before surgery
1.5.2016.-15.9.2018.
Secondary Outcomes (1)
Salivary tumor marker levels after surgery
1.5.2018.-1.9.2019.
Study Arms (3)
Oral Cancer group
Patients with pathohistologically diagnosed T1 conventional oral squamous cell carcinoma. The investigators will collect saliva from the mouth floor (saliva sampling), measure SCCA1, SCCA2 and TROP2 using ELISA tests and measure Ap4A levels using HPLC.
PMOD group
Patients with clinically diagnosed leukoplakia, erythroplakia and oral lichen planus. The investigators will collect saliva from the mouth floor (saliva sampling), measure SCCA1, SCCA2 and TROP2 using ELISA tests and measure Ap4A levels using HPLC.
Control
Age and sex matched subjects. The investigators will collect saliva from the mouth floor (saliva sampling), measure SCCA1, SCCA2 and TROP2 using ELISA tests and measure Ap4A levels using HPLC.
Interventions
Saliva was collected from the mouth floor using a specially designed saliva collecting apparatus.
Saliva samples will be analyzed using enzyme-linked immunosorbent assay (ELISA) for the detection of SCCA1, SCCA2 and TROP2.
High-performance liquid chromatography (HPLC) will be used to measure Ap4A concentrations in saliva.
Eligibility Criteria
All subjects that meet the inclusion criteria.
You may qualify if:
- pathohistologically confirmed conventional T1 oral squamous cell carcinoma
- clinically diagnosed leukoplakia, erythroplakia and oral lichen planus
You may not qualify if:
- ate or drank 2 hours before sampling
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Zagreblead
- Croatian Science Foundationcollaborator
Related Links
Biospecimen
Saliva
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Darko Macan, PhD, DDS
University of Zagreb
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, PhD
Study Record Dates
First Submitted
May 7, 2018
First Posted
May 18, 2018
Study Start
May 1, 2016
Primary Completion
April 1, 2020
Study Completion
April 30, 2020
Last Updated
October 16, 2018
Record last verified: 2018-10