Association of Salivary Amino Acid Level With OSCC Identified By Liquid Chromatography Mass Spectroscopy
OSCC
1 other identifier
observational
110
1 country
2
Brief Summary
Oral Squamous Cell Carcinoma (OSCC) is the most common oral malignancy worldwide. The prognosis of the OSCC patient is not significant despite the modern treatment facilities. Late presentation is one of the most crucial cause of this and for that reason, the importance of early diagnosis of OSCC should be the main concern. Till now, incisional biopsy followed by histopathological examination is the gold standard for diagnosis of oral cancer. The aim of the present study is to find out the association of salivary amino acid levels with oral squamous cell carcinoma, whether the levels are increased or decreased in the patient suffering from OSCC. This might be helpful for early diagnosis of oral cancer and better prognosis.
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 Dec 2020
2 active sites
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
December 15, 2020
CompletedFirst Submitted
Initial submission to the registry
October 25, 2021
CompletedFirst Posted
Study publicly available on registry
December 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedFebruary 22, 2022
February 1, 2022
1.3 years
October 25, 2021
February 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The primary outcome of the study to establish a diagnostic test in the early detection of OSCC.
1\. Total 110 samples, 55 in each group (case and control) will be included in the study and a questionnaire will be filled up by each participant based on their sociodemographic characteristics, personal habit and also the tumor staging of confirmed cancer cases. Saliva metabolite profiling of six amino acids (Alanine, Valine, Glycine, Phenylalanine, Isoleucine, Lysine) will be performed using LCMS/MS system. During metabolite profiling experiments, centroid data will be acquired for each sample from 50 to 1000 Da with a 0.10-sec scan time and a 0.01-sec interscan delay over an 18-min analysis time. 3\. The LCMS/MS data of OSCC and control saliva samples will be analyzed to identify potential discriminant variables. Selecting the method, investigator will create dataset, Researcher would like to (i) detect Peaks and (ii) collect markers. The investigators can create dataset display, and at this point, it is also possible to automatically print data into a text file.
From December,2020 to February, 2022
Study Arms (1)
Patients with Progressive Disease and without Progressive Disease
1. Patients with Progressive Disease Patients with metastasis and/or recurrent OSCC were considered as a group of subjects with progressive disease. 2. Patients with without Progressive Disease Patients without metastasis and/or recurrent OSCC were considered as a group of subjects without progressive disease.
Interventions
To identify the association of elevated level of specific amino acids in OSCC by Liquid Chromatography Mass Spectrometry
Eligibility Criteria
Patients and their attendants attending in outdoor and indoor clinic of Oral and Maxillofacial Surgery Department, BSMMU according to inclusion and exclusion criteria. Total sample size will be 110 and 55 in each group. Cases are the oral squamous cell carcinoma patients confirmed by incisional biopsy and controls are the relatively same age group and healthy individuals.
You may qualify if:
- Age: 18-70 years.
- Both genders.
- Patient with histo-pathologically diagnosedoral squamous carcinoma
- Healthy patients without any malignancy
- Patients relatively almost the same age group of cases
You may not qualify if:
- Patients with severe periodontitis and multiple carious teeth.
- Patients having other systemic diseases and cancer.
- Having severe periodontal problemsor dental caries
- Suffering from any cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Bangladesh Reference Institute for Chemical Measurements
Dhaka, Dhanmondi, 1205, Bangladesh
Bangabandhu Sheikh Mujib Medical University (BSMMU)
Dhaka, 1000, Bangladesh
Biospecimen
Oral saliva is collected for the intervention purpose
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Dipayan Mojumder, BDS
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief Scientific Officer
Study Record Dates
First Submitted
October 25, 2021
First Posted
December 9, 2021
Study Start
December 15, 2020
Primary Completion
March 20, 2022
Study Completion
March 30, 2022
Last Updated
February 22, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share