Investigating the clinical and molecular features of oral cancer and premalignancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

* 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 it's running

• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Xiao Zhao, MD
• Email: xzhao6@mdanderson.org
• Phone: (713) 679-8704

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.