RecruitingNCT06550050

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

Sponsor

M.D. Anderson Cancer Center

Enrollment

1,000 participants

Start Date

Oct 31, 2024

Study Type

OBSERVATIONAL

Conditions

Oral Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

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 Criteria2

\- Pregnant women and/or cognitively-impaired adults are excluded from this study.
\- Prior oral squamous cell carcinoma (OSCC) surgery or OSCC radiation treatment at a non-MDA institution.

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