RECRUITING

Role of Acetaldehyde in the Development of Oral Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a minimal risk intervention study where healthy volunteers and individuals with Fanconi anemia will consume a single dose of alcohol and provide primarily non-invasive biological samples at various time points. Biospecimens to be collected include saliva, oral cells collected via mouthwash and cheek brush, and urine. The collection of two blood samples (5 mL each) will be optional and banked for future use.

Official Title

Dissecting the Role of Acetaldehyde in Oral Carcinogenesis

Quick Facts

Study Start:2022-07-08
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05973656

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 21-45 years of age for alcohol drinkers
  2. * Occasionally consume alcohol
  3. * At least 1 drink per month for healthy volunteers
  4. * At least 1 drink in the last 3 months for Fanconi anemia patients
  5. * Meets one of the three criteria
  6. * Healthy volunteer - ALDH2\*1/1\* homozygotes-not of Eastern Asian decent;
  7. * Healthy volunteer - ALDH2\*1/2\* heterozygotes-of Eastern Asian decent and experience flushing when drinking
  8. * Individual's with Fanconi anemia (FA).
  9. * 18-45 years of age for non-drinkers
  10. * Never consume alcohol/not had alcohol in the last 6 months
  11. * Healthy volunteers.
  12. * Non-smoker (smoked \< 100 cigarettes in a lifetime)
  1. * Pregnant or nursing
  2. * Taking any medication or drug that might affect alcohol use and absorption or that might be affected by alcohol consumption
  3. * Healthy volunteers who have taken any antibiotics in the last 3 months
  4. * Currently consuming more than 21 drinks per week
  5. * Have any history of alcohol or drug related problems
  6. * Current or former tobacco/nicotine product(s) user
  7. * Any regular use of tobacco/nicotine products or marijuana in the last year (cigarettes, e-cigarettes, cigars, pipes, smokeless tobacco)
  8. * "Trying" or limited use of any nicotine products or marijuana in the last 1 month
  9. * Active infection (influenza, cold, COVID, respiratory / sinus infection) - admission in the study will be delayed pending improved health
  10. * Non-FA volunteers who have an unstable medical condition or condition that could be affected by alcohol consumption (insulin-dependent diabetes, ulcers, heart issues)
  11. * Experience severe adverse events (nausea, blacking out) when consuming even low doses of alcohol

Contacts and Locations

Study Contact

Balbo Silvia, PhD
CONTACT
612-624-4240
balbo006@umn.edu

Study Locations (Sites)

Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: Masonic Cancer Center, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-08
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2022-07-08
Study Completion Date2027-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Alcohol-Related Carcinoma
  • Fanconi Anemia
  • Oral Cavity Carcinoma