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Clinical and Molecular Features of Oral Premalignancy and Oral Cancer

Clinical and Molecular Features of Oral Premalignancy and Oral Cancer Associated With Tumor Initiation, Aggressive Behavior, Treatment Response, and Survival Outcomes

Who can join

Ages 18 and older · All sexes

* 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.

About the study

Investigators will employ serial assessments of tissue biopsy and additional biomarkers that reflect burden of disease and predict treatment response. Patients enrolled on this study will be given the option to provide biological samples before, during, and after treatment, as well as functional outcomes of treatment response. These samples will be utilized to develop and validate prognostic and predictive biomarkers for patients undergoing targeted therapy, immunotherapy, surgery, chemotherapy, and/or radiotherapy.

What is being tested

• Radiation (behavioral)

Sponsor: M.D. Anderson Cancer Center · Participants: 1,000 · Started: Oct 31, 2024

Contact the study team

• Xiao Zhao, MD · Phone: (713) 679-8704

Official record on ClinicalTrials.gov — NCT06550050

Locations in the U.S.

Conditions

• Oral Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.