Who is sponsoring NCT03529604?

NCT03529604 is sponsored by University of Zagreb.

What drugs are being tested in NCT03529604?

Interventions in NCT03529604: Saliva sampling, ELISA, HPLC.

What condition does NCT03529604 study?

NCT03529604 studies Oral Cavity Squamous Cell Carcinoma, Saliva Altered, Precancerous Lesions.

Is NCT03529604 still recruiting?

NCT03529604 is currently status unknown. Last updated 16 October 2018.

Last reviewed 2018-10-16 · How we verify

NCT03529604: OCSALTM

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Salivary Ap4A, SCCA, TROP2 in Oral Cancer Patients

Status unknown Last updated 16 October 2018

What this trial tests

trial testing Saliva sampling in Oral Cavity Squamous Cell Carcinoma in 100 participants. Status unknown.

Timeline

1 May 2016

Primary endpoint
1 April 2020

30 April 2020

Quick facts

Lead sponsor	University of Zagreb
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	100
Start date	1 May 2016
Primary completion	1 April 2020
Estimated completion	30 April 2020

Drugs / interventions tested

Saliva sampling — full drug profile →
ELISA
HPLC

Conditions studied

Oral Cavity Squamous Cell Carcinoma — all drugs for Oral Cavity Squamous Cell Carcinoma →
Saliva Altered — all drugs for Saliva Altered →
Precancerous Lesions — all drugs for Precancerous Lesions →

Sponsor

University of Zagreb

Who can join

Eligibility, any sex, with Oral Cavity Squamous Cell Carcinoma or Saliva Altered. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Currently open trials in the same condition.

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Other University of Zagreb trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03529604 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Zagreb
Last refreshed: 16 October 2018

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