Determination of ALDH1b1 and ALDH2 Polymorphisms Frequency in the Brazilian Population (ALDH2020)

May 17, 2021 updated by: Instituto do Cancer do Estado de São Paulo
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

OSCC patients (n = 60) and healthy volunteers (n = 240) matched by age and sex.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case group
OSCC patients (n = 60)
Other: Saliva collection
Saliva collection
Control group
Healthy volunteers (n = 240)
Other: Saliva collection
Saliva collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of ALDH1b1 and ALDH2 polymorphisms
Time Frame: 1 year
Determine the frequency of ALDH1b1 and ALDH2 polymorphisms in OSCC patients and healthy volunteers.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 5 years
Overall survival (case group)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Collaborators

Instituto de Ciências Biomédicas da Universidade de São Paulo

Investigators

  • Principal Investigator: Gilberto de Castro Junior, MD, PhD, Instituto do Cancer do Estado de Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 2, 2022

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

February 12, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (ACTUAL)

February 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP1553/19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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