Risk Assessment Methods for Stomach Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Non-Hispanic White, Gastric cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores various methods to assess the risk of stomach cancer. It will evaluate the effectiveness of breath tests for H. pylori (a bacterium linked to stomach issues), including the Breath Test for Acetaldehyde, as well as questionnaires and endoscopies (a procedure using a tube to examine the stomach) in identifying individuals at higher risk for this cancer. The goal is to detect stomach cancer earlier by pinpointing those at increased risk. This study suits individuals aged 40 to 80 who identify as Asian, Hispanic, or Black American and are willing to undergo tests such as blood samples and endoscopies. As an unphased trial, it offers a unique opportunity to contribute to significant research that could lead to earlier detection of stomach cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these risk assessment methods are safe for identifying high-risk stomach cancer participants?

Research shows that breath tests, such as the H. pylori test, are generally easy for people to handle. Studies have found that these tests can safely detect certain bacteria that might increase the risk of stomach problems, including cancer. Reports of side effects from these tests are rare, making them a safe choice for screening. An endoscopy, which uses a thin, flexible tube to examine the stomach, is also safe, though it might feel uncomfortable for some people. Overall, these methods are widely used and considered safe for assessing the risk of stomach cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel risk assessment method for stomach cancer using a breath test. Unlike traditional methods that rely heavily on invasive procedures like endoscopies and biopsies, this breath test offers a non-invasive alternative for detecting Helicobacter pylori, a bacteria linked to gastric cancer. This approach could make early detection more accessible and less uncomfortable for patients, potentially leading to earlier intervention and better outcomes. Additionally, the trial includes a comprehensive risk assessment over time, providing a more dynamic understanding of an individual's risk profile.

What evidence suggests that these risk assessment methods are effective for identifying high-risk stomach cancer patients?

This trial will assess the effectiveness of various risk assessment methods for stomach cancer, including breath tests. Research has shown that breath tests can identify individuals at high risk for stomach cancer by detecting specific substances in the breath. Studies have found that these tests accurately identify chemicals linked to cancer. For example, one study showed that using breath tests for early cancer detection can significantly improve survival rates. Evidence also suggests a strong link between certain chemicals, such as acetaldehyde found in breath samples, and cancer risk. Overall, breath tests are emerging as a promising and non-invasive method to assess early cancer risk. ^{1 6 7 8 9}

Who Is on the Research Team?

Yanghee Woo

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals who may be at high risk of developing stomach cancer. It's particularly focused on those who might have an infection with H. pylori, a bacteria linked to stomach ulcers and cancer.

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative

Assent, when appropriate, will be obtained per institutional guidelines

Identify as a racial minority either Asian, Hispanic, or Black American

Exclusion Criteria

History of upper endoscopy within 2 years

A direct study team member

An employee who is under the direct/indirect supervision of the principal investigator (PI)/a coinvestigator/the study manager

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

At time of screening up to 3 years

Initial Risk Assessment

Participants complete questionnaires, undergo collection of a blood sample, and undergo an H. pylori breath test for gastric cancer risk assessment at baseline

Baseline

1 visit (in-person)

Cohort I - EGD and Biopsy

High-risk participants may undergo esophagogastroduodenoscopy (EGD) with possible tissue biopsy within 3 months of baseline risk assessment and complete questionnaires annually up to 3 years

3 months for EGD, annually up to 3 years for questionnaires

Cohort II - Questionnaires

Non-high risk participants complete questionnaires for re-assessment annually up to 3 years and may undergo EGD at year 2

Annually up to 3 years

Follow-up

Participants are monitored annually for a total of 3 years

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Breath Test

Trial Overview The study tests the effectiveness of various methods like breath tests for H. pylori, questionnaires about health history, and endoscopies (a tube with a camera inserted through the mouth) to find people at high risk for stomach cancer.

How Is the Trial Designed?

Group I: Part II, Cohort I (EGD, biopsy) Experimental Treatment 3 Interventions

Participants may undergo EGD with possible tissue biopsy within 3 months of baseline risk assessment and complete questionnaires annually up to 3 years.

Group II: Part I (initial risk assessment) Experimental Treatment 3 Interventions

Participants complete questionnaires, undergo collection of a blood sample, and undergo an H. pylori breath test for gastric cancer risk assessment at baseline.

Group III: Part II, Cohort II (questionnaires) Active Control 2 Interventions

Participants complete questionnaires for re-assessment annually up to 3 years and may undergo EGD at year 2.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Mice lacking the ALDH2 enzyme (Aldh2-/-) showed lower levels of DNA damage from acetaldehyde exposure compared to normal mice (Aldh2+/+), indicating that ALDH2 plays a crucial role in detoxifying acetaldehyde and preventing DNA adduct formation.

The study suggests that individuals with inactive ALDH2 may have a higher risk of developing cancers in the nasal epithelium and lungs due to increased susceptibility to acetaldehyde exposure, highlighting the importance of ALDH2 in cancer risk assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of acetaldehyde inhalation in mitochondrial aldehyde dehydrogenase deficient mice (Aldh2-/-). Oyama, T., Nagayoshi, H., Matsuda, T., et al.[2022]

Acetaldehyde, a toxic byproduct of alcohol metabolism, can be detected in breath and varies significantly among individuals due to genetic and environmental factors, with concentrations reaching up to 500 nmol/l in some populations after alcohol consumption.

Breath acetaldehyde levels can be influenced by genetic variations, such as the inactive form of aldehyde dehydrogenase (ALDH2) found in many individuals of Asian descent, and can be significantly elevated when combined with alcohol-sensitizing drugs like calcium carbimide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring and reporting the concentration of acetaldehyde in human breath. Jones, AW.[2013]

Genetic variations in the ALDH2 and ADH genes increase the risk of cancer from acetaldehyde exposure in alcohol drinkers, highlighting acetaldehyde as a significant carcinogen linked to both esophageal and gastric cancers.

Acetaldehyde is produced not only from alcohol consumption but also from certain foods and tobacco smoke, suggesting a need for global monitoring of acetaldehyde levels in alcoholic beverages and fermented foods, as well as potential interventions using L-cysteine to reduce its harmful effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acetaldehyde and gastric cancer. Salaspuro, M.[2013]

Acetaldehyde, a metabolite of ethanol, is identified as a significant carcinogen in humans, particularly affecting the upper digestive tract, and is produced from various sources including alcohol, tobacco smoke, and certain foods.

There is a strong recommendation for global screening of acetaldehyde levels in food and beverages, especially for individuals with genetic predispositions to higher acetaldehyde exposure, and a call to re-evaluate its safety status as a food additive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acetaldehyde as a common denominator and cumulative carcinogen in digestive tract cancers. Salaspuro, M.[2021]

A study involving 30 volunteers over 6 months used selected-ion flow-tube mass spectrometry (SIFT-MS) to measure breath levels of ethanol and acetaldehyde, finding mean ethanol levels of 196 ppb and acetaldehyde levels of 24 ppb.

The research suggests that breath analysis could be a promising tool for clinical diagnosis, potentially helping to detect conditions like bacterial overload in the gut or tumors in the body, based on the volatile compounds present in exhaled breath.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A longitudinal study of ethanol and acetaldehyde in the exhaled breath of healthy volunteers using selected-ion flow-tube mass spectrometry. Turner, C., Spanel, P., Smith, D.[2013]

Breath acetaldehyde can be a useful biomarker for assessing exposure to ethanol and understanding its metabolism, especially in individuals with ALDH2 deficiency, but its interpretation is complicated by factors like smoking and drinking habits.

Current methods for measuring breath acetaldehyde need standardization and further research to improve accuracy, as low levels may not reliably indicate blood acetaldehyde concentrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The determination of acetaldehyde in exhaled breath. Tardif, R.[2019]

The study measured acetaldehyde levels in blood and breath of human volunteers, showing that using calcium carbimide (an aldehyde dehydrogenase inhibitor) significantly increased acetaldehyde concentrations compared to ethanol treatment alone.

After treatment with calcium carbimide and ethanol, peak blood acetaldehyde levels reached as high as 188 µM, while ethanol alone resulted in much lower levels (6-11 µM), indicating that inhibiting aldehyde dehydrogenase can lead to higher acetaldehyde accumulation in the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breath and blood acetaldehyde concentrations and their correlation during normal and calcium carbimide-modified ethanol oxidation in man. Stowell, AR., Lindros, KO., Salaspuro, MP.[2019]

Individuals with ALDH2 deficiency, who consume alcohol, are exposed to approximately double the daily dose of acetaldehyde compared to those with normal ALDH2 activity, leading to significantly increased cancer risks.

The study suggests that previous animal-based risk assessments for acetaldehyde may have underestimated its cancer risk, particularly for head and neck and esophageal cancers, indicating a need for revised human risk assessments based on genetic and biochemical evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ALDH2-deficiency as genetic epidemiologic and biochemical model for the carcinogenicity of acetaldehyde. Lachenmeier, DW., Salaspuro, M.[2018]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/jco.2015.33.3_suppl.18

Acetaldehyde/ethanol breath test for identifying people at ... Our breath test may be a convenient screening tool for identifying those at high risk of upper aerodigestive tract cancer.

2. iopscience.iop.org iopscience.iop.org/article/10.1088/1752-7163/adc979

Stomach cancer identification based on exhaled breath ... This review discusses invasive and non-invasive diagnostic methods for stomach cancer, with a special emphasis on breath analysis and electronic nose (e-nose) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9820758/

Diagnosis by Volatile Organic Compounds in Exhaled Breath ... This study describes how VOCs can be used to precisely detect cancers; as more data are accumulated, the accuracy of this method will increase.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2949819825000019

Breath- and blood-based molecular assessment for ... Conversely, early diagnosis and treatment of gastroesophageal cancer demonstrates markedly improved outcomes, with 5-year overall survival rates ranging from 83 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8133406/

Acetaldehyde breath test as a cancer risk marker in ... The results of this study showed a strong correlation between acetaldehyde and ethanol levels in each breath sample. The following reasons have been proposed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5256369/

Alcohol Consumption & Gastric Cancer Risk: Meta-Analysis Our meta-analysis showed that alcohol consumption elevated the risk of gastric cancer with an odds ratio (OR) of 1.39 (95% CI 1.20–1.61).

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/j.1751-2980.2011.00480.x

Acetaldehyde and gastric cancer - SALASPURO - 2011 The generally regarded as safe status of acetaldehyde should be re-evaluated. The as low as reasonably achievable principle should be applied to ...

8. hhs.gov hhs.gov/sites/default/files/oash-alcohol-cancer-risk.pdf

Alcohol and Cancer Risk 2024 At high levels such as those that occur with consumption of alcohol, acetaldehyde is highly toxic and cancer-causing.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04022109

Screening of Gastric Cancer Via Breath Volatile Organic ... Testing of volatile markers will be conducted by one of two methods: 1) gas chromatography coupled to mass spectroscopy (GS-MS) and 2) sensor technology.