Determination of ALDH1b1 and ALDH2 Polymorphisms Frequency in the Brazilian Population

Oral Squamous Cell Carcinoma (OSCC) Clinical Trial

— ALDH2020  

Official title:

Determination of ALDH1b1 and ALDH2 Polymorphisms Frequency in the Brazilian Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04270201
• Other study ID #: NP1553/19
• Status: Not yet recruiting
• Start date: January 2, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2021
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: Isabela C de Souza
• Phone: +5511982496744
• Email: isabelasouza[@]usp.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A case-control study with oral squamous cell carcinoma (OSCC) patients from Instituto do Câncer do Estado de São Paulo (ICESP) and healthy volunteers. In this study, it will be collected saliva samples from both groups that will be submitted to sequencing analysis to evaluate the frequency of ALDH1b1 and ALDH2 polymorphisms in the Brazilian population. Also, correlate OSCC risk to alcohol consumption or smoke, by applied questionnaires.

Description:

According to the World Health Organization (WHO), in 2016 there were 3 million deaths worldwide from alcohol abuse. ALDH1b1 and ALDH2 proteins are involved in the alcohol metabolism promoting the conversion of acetaldehyde to acetate. The genes that encode these proteins have genetic variants, also called polymorphisms, that can promote changes in their functions such as the accumulation of acetaldehyde in the body, resulting in facial flushing, tachycardia and headache. Studies reported the correlation between alcohol consumption and/or smoking and these polymorphisms to a higher risk for head and neck cancer, including oral squamous cell carcinoma (OSCC). The aim of this study is to determine the frequency of the ALDH1b1 and ALDH2 polymorphisms in the Brazilian population, in addition to estimating the risk for OSCC among those with polymorphisms. For this, unstimulated saliva samples will be collected from OSCC patients and healthy volunteers. All study participants must complete two questionnaires on alcohol consumption, smoking and disease history. Saliva samples will be collected using the DNA/RNA Shield Saliva Collection Kit and stored at -20ºC. The DNA will be extracted, quantified by the Nanodrop equipment and amplified by the polymerase chain reaction (PCR), using specific primers for each of the genetic variants. The PCR product will be sent to the Sequencing Service of the Centro de Pesquisas sobre o Genoma Humano e Células-Tronco/IBUSP, where the Sanger sequencing technique will be performed and the results will be analyzed in the ICB-USP laboratory. For the group of patients, medical records will be monitored to correlate clinical data and genetic variants with overall survival. These data will allow the characterization of the genetic variants of ALDH1b1 and ALDH2 in the Brazilian population and support the development of future public policies to reduce the main risk factors for OSCC, especially among those with these genetic variants.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• OSCC diagnostic for case group

• Able to read and sign the consent form.

• Able for saliva collection.

• Able to understand the applied questionnaires.

Exclusion Criteria:

• Unable to read and sign the consent form.

• Unable for saliva collection.

• Unable to understand the applied questionnaires.

• OSCC patient's companions for healthy volunteers.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Oral Squamous Cell Carcinoma (OSCC)

Intervention

Other:
• Saliva collection
Saliva collection

Locations

Country	Name	City	State
Brazil	Instituto do Câncer do Estado de São Paulo	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo	Instituto de Ciências Biomédicas da Universidade de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of ALDH1b1 and ALDH2 polymorphisms	Determine the frequency of ALDH1b1 and ALDH2 polymorphisms in OSCC patients and healthy volunteers.	1 year
Secondary	Survival	Overall survival (case group)	5 years