Oral Squamous Cell Carcinoma (OSCC)ALDH2020NCT04270201
Determination of ALDH1b1 and ALDH2 Polymorphisms Frequency in the Brazilian Population
An observational study of Oral Squamous Cell Carcinoma (OSCC), run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Squamous Cell Carcinoma (OSCC)
- What is being tested?
- Saliva collection
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2022to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: OSCC patients (n = 60) and healthy volunteers (n = 240) matched by age and sex.
Who may be able to join
- OSCC diagnostic for case group
- Able to read and sign the consent form.
- Able for saliva collection.
- Able to understand the applied questionnaires.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Câncer do Estado de São Paulo
São Paulo, São Paulo, 01246-000
Gilberto de Castro Junior, MD, PhD, +55 11 3896-2686, gilberto.castro@usp.br
About this study
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.
Read the 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.
- Conditions
- Oral Squamous Cell Carcinoma (OSCC)
- Being tested
- Saliva collection
- Keywords
- Oral squamous cell carcinoma, ALDH1b1, ALDH2, polymorphism
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva collectionOther
Saliva collection
| Study group | Role | What they receive |
|---|---|---|
| Case group | OSCC patients (n = 60) Receives: Other: Saliva collection | |
| Control group | Healthy volunteers (n = 240) Receives: Other: Saliva collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of ALDH1b1 and ALDH2 polymorphisms
Determine the frequency of ALDH1b1 and ALDH2 polymorphisms in OSCC patients and healthy volunteers.
Measured: 1 year
Secondary outcomes (1)
Survival
Overall survival (case group)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start2 Jan 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell Carcinoma (OSCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Ciências Biomédicas da Universidade de São Paulo
- Responsible party
- Sponsor
- Investigators
- Gilberto de Castro Junior, MD, PhD, Principal investigator, Instituto do Câncer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270201
- Sponsor's protocol ID
- NP1553/19
- Acronym
- ALDH2020
- Status last verified
- May 2021
- First submitted
- 12 Feb 2020
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of ALDH1b1 and ALDH2 Polymorphisms Frequency in the Brazilian Population
- ClinicalTrials.gov ID
- NCT04270201
- Acronym / sponsor ID
- ALDH2020 / NP1553/19
- Conditions
- Oral Squamous Cell Carcinoma (OSCC)
- Keywords
- Oral squamous cell carcinoma, ALDH1b1, ALDH2, polymorphism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Collaborators
- Instituto de Ciências Biomédicas da Universidade de São Paulo
- Study start
- 2 Jan 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: Saliva collectionOSCC patients (n = 60) |
| Control group | – | Other: Saliva collectionHealthy volunteers (n = 240) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- OSCC patients (n = 60) and healthy volunteers (n = 240) matched by age and sex.
Key inclusion criteria (4 listed)
- OSCC diagnostic for case group
- Able to read and sign the consent form.
- Able for saliva collection.
- Able to understand the applied questionnaires.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva collectionSaliva collection | Other | Case group, Control group |
Primary outcome
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 secondary outcome
Survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilberto de Castro Junior, MD, PhD principal investigator
Instituto do Câncer do Estado de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Squamous Cell Carcinoma (OSCC), run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabela C de Souza (+5511982496744, isabelasouza@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of ALDH1b1 and ALDH2 polymorphisms (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.