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

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Blood, tissue and saliva specimen will be collected. Surveys will be administered.

Blood collection

Tissue collection

The Behavioral Risk Factor Surveillance System (BRFSS), Functional Assessment of Cancer Therapy - Head and Neck module (FACT-HN) the Chicago Priority Scale, Cancer Survivor Unmet Needs surveys will be administered at baseline and 3 months post-surgery.

Surveys

Besim Ogretmen, PhD

The purpose of this research study is to see if it is possible to collect tissue, saliva and blood samples from patients who are having surgery and send those samples to different labs across MUSC. The researchers in these labs will collect tissue, blood and saliva samples before surgery and during surgery to see if there are any changes in the samples. They will compare the changes in the samples to the clinical outcomes. Patients will also be given surveys to evaluate patient preferences, anxiety/distress, symptom severity, support by HPV status.

The primary objective of this exploratory, proof of concept study is to facilitate translational science spanning clinicians and basic scientists to obtain tissue samples, PDX models, and clinical data in order to successfully analyze tissue linked to clinical outcomes in head and neck cancer, resulting in the methodological and statistical framework for a larger scale clinical trial in the future. While the incidence of HNSCC has been steadily decreasing over the last thirty years, the incidence and prevalence of oropharyngeal cancer squamous cell carcinoma (OPSCC) and young patients with oral tongue cancer has increased in the face of an overall decline in smoking prevalence. Over the past few years, evidence has emerged that oropharyngeal cancer is rising in incidence so rapidly that it has been described as an "epidemic" and that it has or soon will surpass cervical cancer in both incidence and mortality. In fact, over 30,000 patients will be diagnosed with oropharyngeal cancer in the US per year, making it the most rapidly rising head and neck cancer in incidence. Despite this unique etiopathogenesis, treatment and toxicities related to treatment have not changed. This collaboration and interdisciplinary study will be the first of its kind to address these important issues of cancer site, HPV status, tobacco history, gender, age, and race using both patient tissue and PDX models to identify novel and unique biomarkers. Also, innate to this project is the link between five separate laboratories each conducting unique biomarker analysis.

Transdisciplinary Oral/Oropharyngeal Cancer Research & Care in Head and Neck Cancer (TORCH)

Transdisciplinary Oral/Oropharyngeal Cancer Research & Care in Head and Neck Cancer (TORCH): A Prospective Non-Randomized Study by the Head and Neck Oncology Group (HNOG) at the Medical University of South Carolina (MUSC)

The number of participants to have research blood, saliva and tissues samples collected.

Medical University of South Carolina

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

45 female patients will be screened to participate.

45 male patients will be screened to participate

Pre-surgery, two 500 ml of exhaled breath volatiles (EBV) in each of 4 collection tubes will be collected in 5-7 min of breathing

Breath Collection

Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes

Saliva Collection

Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube

Blood Collection

Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers

Urine Collection

During surgical tumor removal, a tumor tissue sample will be collected

Tumor Collection

Medical history will be obtained from the patients charts to identify demographics (age, race, ethnicity, zip code), oncologic history (date of diagnosis and cancer type), and medical history of disease.

Medical History Data Collection

Andrew Bishop, PhD

This pilot study will establish non-invasive sample collections, including breath, saliva, blood and urine pre-surgery and at the participant's one-month post-surgery follow-up visit. Participants with suspected non-small cell lung cancer (NSCLC) stage I-III will be recruited.

Primary Objective

* To evaluate the feasibility of adding non-invasive sample collections in the pre-surgical setting and at the post-surgery follow-up visit.
* To identify and assess metabolic and microbial signatures collected at pre- and post-surgery and determine which are indicative of lung cancer.

Secondary Objective

* To identify signatures which are associated with lung cancer stage.
* To identify signatures which are impacted by patient's pulmonary function status.

Metabolic and Microbial Profiling of Lung Cancer

Pilot Study: Metabolic and Microbial Profiling of Lung Cancer

The primary objectives is to assess the feasibility of adding these non-invasive sample collections to pre- and post-surgery visits the following outcomes (counts) will be gathered - (number eligible for trial, number that consent to participate, number that provide pre-surgery samples, number that provide post-surgery samples) using a 95% exact Clopper-Pearson confidence interval for each feasibility estimate.

Metabolic assessments will be taken before and after surgery of lung cancer biomarkers to examine a series of paired t-tests to determine which markers significantly change between the two time points for participants.

For lung cancer examine whether pre-surgery, post-surgery or change from pre- to post- surgery metabolic or microbial measures are different depending on lung cancer stage. Consideration of the metabolic or microbial measures as outcomes and use a general linear models framework to see if lung cancer stage (included as a class variable, but then examined as an ordinal variable using a contrast statement in general linear model) is associated with any marker.

For pulmonary function, the same approach as for lung cancer stage, except that pulmonary function will be considered as a continuous variable in the model. Pulmonary function can be examined at both time-points (pre- and post- surgery) thus we can examine the relationships between pulmonary function measures and biomarker measures at each time points (and the change in measures over time).

National Cancer Institute (NCI)

Wake Forest University Health Sciences

There were no female participants enrolled on this study before it was terminated.

45 female patients will be screened to participate.

Breath Collection: Pre-surgery, two 500 ml of exhaled breath volatiles (EBV) in each of 4 collection tubes will be collected in 5-7 min of breathing

Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes

Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube

Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers

Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected

Medical History Data Collection: Medical history will be obtained from the patients charts to identify demographics (age, race, ethnicity, zip code), oncologic history (date of diagnosis and cancer type), and medical history of disease.

Female Participants

45 male patients will be screened to participate

Breath Collection: Pre-surgery, two 500 ml of exhaled breath volatiles (EBV) in each of 4 collection tubes will be collected in 5-7 min of breathing

Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes

Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube

Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers

Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected

Medical History Data Collection: Medical history will be obtained from the patients charts to identify demographics (age, race, ethnicity, zip code), oncologic history (date of diagnosis and cancer type), and medical history of disease.

Male Participants

Total

Enrolled participant

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study Coordinator

Biosamples that were collected were not analyzed as the analysis would be done once a proper batch of samples were collected. Given that never happened, investigators have no study results to report.

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
Transdisciplinary Oral/Oropharyngeal Cancer Research & Care in Head and Neck Cancer (TORCH)	NCT03735745	Head and Neck C...	Blood collectio... Saliva collecti... Tissue collecti... Surveys	18 Years -	Medical University of South Carolina
Metabolic and Microbial Profiling of Lung Cancer	NCT03998189	Nonsmall Cell L... Nonsmall Cell L...	Breath Collecti... Saliva Collecti... Blood Collectio... Urine Collectio... Tumor Collectio... Medical History...	18 Years -	Wake Forest University Health Sciences
Metabolic and Microbial Profiling of Lung Cancer	NCT03998189	Nonsmall Cell L... Nonsmall Cell L...	Breath Collecti... Saliva Collecti... Blood Collectio... Urine Collectio... Tumor Collectio... Medical History...	18 Years -	Wake Forest University Health Sciences
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 saliva collection