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

Trial Summary

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.

Is the acetaldehyde breath test safe for humans?

The acetaldehyde breath test involves exposure to acetaldehyde, which is considered a carcinogen (a substance that can cause cancer) in humans. Acetaldehyde is linked to an increased risk of cancers in the digestive tract, especially in individuals with certain genetic traits or conditions. Therefore, the safety of this test should be carefully evaluated, especially for those at higher risk. ^{1 2 3 4 5}

Is the treatment in the trial 'Risk Assessment Methods for Stomach Cancer' a promising treatment?

The research articles focus on acetaldehyde, a chemical linked to cancer risk, especially in people with certain genetic traits. They suggest that understanding and measuring acetaldehyde levels could help in assessing cancer risk, which might be useful in developing new treatments or prevention strategies for stomach cancer. However, the articles do not directly mention a specific treatment being tested in the trial, so it's unclear if a particular treatment is promising based on this information. ^{1 2 6 7 8}

What is the purpose of this trial?

This clinical trial evaluates the usefulness of various risk assessment tests, including Helicobacter pylori (H. pylori) breath testing, questionnaires, and endoscopies for identifying participants at high risk for stomach cancer. H. pylori is a bacteria that causes stomach inflammation and ulcers in the stomach. People with H. pylori infections may be more likely to develop cancer in the stomach. H. pylori breath testing can help identify the presence of H. pylori infection in a participant and help identify if the participant may be at a higher risk of developing stomach cancer. An endoscopy uses a thin, flexible lighted tube that is inserted inside the esophagus, stomach, and first part of the small intestine. This allows the doctor to see and look for abnormal areas that may need to be biopsied. Risk assessment including H. pylori evaluation, questionnaires, and endoscopies may help identify participants at high risk for stomach cancer and may be a useful screening tool for earlier stomach cancer diagnosis.

Research Team

Yanghee Woo

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The determination of acetaldehyde in exhaled breath. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

ALDH2-deficiency as genetic epidemiologic and biochemical model for the carcinogenicity of acetaldehyde. [2018]

3. Australia pubmed.ncbi.nlm.nih.gov

Acetaldehyde and gastric cancer. [2013]

4. England pubmed.ncbi.nlm.nih.gov

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

5. Singapore pubmed.ncbi.nlm.nih.gov

Effects of acetaldehyde inhalation in mitochondrial aldehyde dehydrogenase deficient mice (Aldh2-/-). [2022]

6. England 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. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Breath and blood acetaldehyde concentrations and their correlation during normal and calcium carbimide-modified ethanol oxidation in man. [2019]

8. England pubmed.ncbi.nlm.nih.gov

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