Oral Cavity Squamous Cell Carcinoma Clinical Trial
— OCSALTMOfficial title:
Isolation, Quantification and Kinetics of Salivary Ap4A, SCCA and TROP2 in Patients With Oral Cancer and Potentially Malignant Oral Disorders
Verified date | October 2018 |
Source | University of Zagreb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | April 30, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - pathohistologically confirmed conventional T1 oral squamous cell carcinoma - clinically diagnosed leukoplakia, erythroplakia and oral lichen planus Exclusion Criteria: - ate or drank 2 hours before sampling |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Zagreb | Croatian Science Foundation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Salivary tumor marker levels before surgery | Salivary tumor marker levels before surgery | 1.5.2016.-15.9.2018. | |
Secondary | Salivary tumor marker levels after surgery | Salivary tumor marker levels after surgery | 1.5.2018.-1.9.2019. |
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