Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

Saliva collection

Isabela C de Souza

Gilberto de Castro Junior, MD, PhD

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.

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.

Determination of ALDH1b1 and ALDH2 Polymorphisms Frequency in the Brazilian Population

Determine the frequency of ALDH1b1 and ALDH2 polymorphisms in OSCC patients and healthy volunteers.

Instituto de Ciências Biomédicas da Universidade de São Paulo

Instituto do Cancer do Estado de São Paulo

Skin and Connective Tissue Diseases

Digestive System Diseases

Mouth and Tooth Diseases

Wounds and Injuries

Dermatitis

Mucositis

Radiodermatitis

Skin Diseases

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Ling-Wei Wang, MD

The purpose of this study is to evaluate the effect of ALDH2 mutation in radiation associating dermatitis or mucositis in head and neck cancer patients who accept chemoradiation therapy

* One-site audit. The enrolled subject is confirmed by PIs

  ◦◦Source data is compared to external data sources medical records, either paper or electronic case report forms.
* NCI CTCAE v5.0 for AE records
* Patient recruitment according to inclusion criteria: 1. Newly diagnosed locally head and neck squamous cell carcinoma; 2. Apply for primary chemoradiation or adjuvant chemoradiation; 3. Signed informed consent
* Sample size assessment: 60 subjects will be included in one year for total 120 subjects
* Missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results
* Fisher's exact test is for category comparison. Kaplan-Meier analysis is for survival analysis. AE grades will be analyzed according to NCI guideline. Two-side p \< 0.05 is suggested significant.

ALDH2 Mutation in Taiwanese Head and Neck Cancer

Correlation Between Radiation Dermatitis/Mucositis and ALDH2 Mutation in Taiwanese Head and Neck Cancer

The side effects of each participant will be recorded accoiding to CTCAEv5.0 during the whole course of chemoradiation, by indicated physicians regularly

Taipei Veterans General Hospital, Taiwan

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Determination of ALDH1b1 and ALDH2 Polymorphisms Frequency in the Brazilian Population	NCT04270201	Oral Squamous C...	Saliva collecti...	18 Years -	Instituto do Cancer do Estado de São Paulo
ALDH2 Mutation in Taiwanese Head and Neck Cancer	NCT02761408	Dermatitis Mucositis		21 Years - 70 Years	Taipei Veterans General Hospital, Taiwan
Determination of ALDH1b1 and ALDH2 Polymorphisms Frequency in the Brazilian Population	NCT04270201	Oral Squamous C...	Saliva collecti...	18 Years -	Instituto do Cancer do Estado de São Paulo

Spots Global Cancer Trial Database for aldh2

Every month we try and update this database with for aldh2 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for aldh2

Every month we try and update this database with for aldh2 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for aldh2 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.