Salivary Ap4A, SCCA, TROP2 in Oral Cancer Patients

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.

Conditions

• Oral Cavity Squamous Cell Carcinoma
• Saliva Altered
• Precancerous Lesions

Interventions

OTHER

Saliva sampling

Saliva was collected from the mouth floor using a specially designed saliva collecting apparatus.

DIAGNOSTIC_TEST

ELISA

Saliva samples will be analyzed using enzyme-linked immunosorbent assay (ELISA) for the detection of SCCA1, SCCA2 and TROP2.

DIAGNOSTIC_TEST

HPLC

High-performance liquid chromatography (HPLC) will be used to measure Ap4A concentrations in saliva.

Sponsors & Collaborators

• Croatian Science Foundation

  collaborator OTHER_GOV

• University of Zagreb

  lead OTHER

Principal Investigators

• Darko Macan, PhD, DDS · University of Zagreb

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-05-01

Primary Completion

2020-04-01

Completion

2020-04-30