Investigating the clinical and molecular features of oral cancer and premalignancy
Clinical and Molecular Features of Oral Premalignancy and Oral Cancer Associated With Tumor Initiation, Aggressive Behavior, Treatment Response, and Survival Outcomes
This study is trying to find out what causes oral cancer and how different factors affect treatment and quality of life for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation, chemotherapy, immunotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06550050 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on understanding the clinical, environmental, and genetic factors that contribute to the risk of developing oral cancer. Participants will provide biological samples before, during, and after treatment, which will be analyzed to develop prognostic and predictive biomarkers. The study aims to identify clinical and molecular predictors of treatment response, toxicity, and overall patient outcomes. Additionally, it seeks to assess how these factors influence patients' quality of life through validated self-report instruments.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with a diagnosis of oral premalignant or malignant tumors.
Not a fit: Patients who are pregnant or cognitively impaired will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic markers and treatment strategies for patients with oral cancer.
How similar studies have performed: Other studies have shown success in identifying biomarkers for various cancers, suggesting that this approach may yield valuable insights as well.
Eligibility criteria
Show full inclusion / exclusion criteria
* Aged 18 or older, with a diagnosis of oral premalignant or malignant tumors (eligible diagnoses listed below) or presenting with suspected premalignant or malignant tumors for definitive diagnosis * Must be able to provide informed consent * Oral premalignant or malignant tumors presenting for evaluation for the first time at UT MD Anderson Cancer Center * Oral premalignant or malignant tumors who were previously treated or evaluated at UT MD Anderson Cancer Center who presents for evaluation of progressive or recurrent disease. Newly collected biospecimens and tissue samples will be linked to applicable samples previously collected and banked/stored under PA17-0050, LAB02-427, Lab02-039 and Lab08-0848. Eligible diagnoses include: * Leukoplakia * Erythroplakia * Mild dysplasia * Moderate dysplasia * Severe dysplasia * Carcinoma in situ * Squamous cell carcinoma Exclusion: \- Pregnant women and/or cognitively-impaired adults are excluded from this study. Exclusion Criteria: \- Prior oral squamous cell carcinoma (OSCC) surgery or OSCC radiation treatment at a non-MDA institution.
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Xiao Zhao, MD
- Email: xzhao6@mdanderson.org
- Phone: (713) 679-8704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.