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Salivary Ap4A, SCCA, TROP2 in Oral Cancer Patients (OCSALTM)

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ClinicalTrials.gov Identifier: NCT03529604
Recruitment Status : Active, not recruiting
First Posted : May 18, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
Croatian Science Foundation
Information provided by (Responsible Party):
Darko Macan, University of Zagreb

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.


Condition or disease Intervention/treatment
Oral Cavity Squamous Cell Carcinoma Saliva Altered Precancerous Lesions Other: Saliva sampling Diagnostic Test: ELISA Diagnostic Test: HPLC

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Isolation, Quantification and Kinetics of Salivary Ap4A, SCCA and TROP2 in Patients With Oral Cancer and Potentially Malignant Oral Disorders
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Group/Cohort Intervention/treatment
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.
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.

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.
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.

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.
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.




Primary Outcome Measures :
  1. Salivary tumor marker levels before surgery [ Time Frame: 1.5.2016.-15.9.2018. ]
    Salivary tumor marker levels before surgery


Secondary Outcome Measures :
  1. Salivary tumor marker levels after surgery [ Time Frame: 1.5.2018.-1.9.2019. ]
    Salivary tumor marker levels after surgery


Biospecimen Retention:   Samples With DNA
Saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All subjects that meet the inclusion criteria.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529604


Sponsors and Collaborators
University of Zagreb
Croatian Science Foundation
Investigators
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Principal Investigator: Darko Macan, PhD, DDS University of Zagreb

Additional Information:
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Responsible Party: Darko Macan, Professor, PhD, University of Zagreb
ClinicalTrials.gov Identifier: NCT03529604     History of Changes
Other Study ID Numbers: HRZZ IP-09-2014-9376
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Darko Macan, University of Zagreb:
Oral Cancer
Potentially Malignant Oral Disorders
Saliva
Squamous cell carcinoma antigen 1
Squamous cell carcinoma antigen 2
Trophoblast cell surface antigen
Diadenosine tetraphosphate
Additional relevant MeSH terms:
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Mouth Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Carcinoma
Carcinoma, Squamous Cell
Stomatognathic Diseases
Diadenosine tetraphosphate
Squamous cell carcinoma-related antigen
Serpins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors