Actively Recruiting
Clinical and Molecular Features of Oral Premalignancy and Oral Cancer Associated With Tumor Initiation, Aggressive Behavior, Treatment Response, and Survival Outcomes
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
1000
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying oral premalignant and malignant tumors to understand the clinical, environmental, and genetic factors that increase the risk of developing oral cancers and their aggressive behaviors. The study aims to identify molecular and clinical markers that predict diagnosis, treatment response, toxicity, and overall outcomes. This observational study also seeks to understand how treatment and clinical factors affect patients' quality of life and functional outcomes over time. Participants will be observed without receiving experimental treatments; standard care such as radiation may be involved as part of usual treatment. Biological samples including tissue biopsies and other biomarkers will be collected before, during, and after treatment. These samples will help researchers develop and validate biomarkers related to disease burden and treatment response. The study includes patients undergoing various treatments like targeted therapy, immunotherapy, surgery, chemotherapy, and radiotherapy. Participants will provide biological samples and complete assessments of functional outcomes and quality of life using validated questionnaires such as the MD Anderson Symptom Inventory for Head and Neck Cancer. Data will be collected over up to five years to monitor symptoms, swallowing difficulties, and other long-term effects. This information helps researchers understand prognosis and treatment impact. Participants’ clinical and molecular data will be linked with previously collected specimens where applicable.
CONDITIONS
Brief Title
Clinical and Molecular Features of Oral Premalignancy and Oral Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 or older with a diagnosis or suspicion of oral premalignant or malignant tumors
- Able to provide informed consent
- Presenting for evaluation of oral premalignant or malignant tumors for the first time at MD Anderson Cancer Center
- Previously treated or evaluated at MD Anderson Cancer Center with progressive or recurrent disease and willing to provide new biospecimens
- Diagnoses include leukoplakia, erythroplakia, mild to severe dysplasia, carcinoma in situ, or squamous cell carcinoma
You will not qualify if you...
- Pregnant women
- Cognitively impaired adults
- Prior oral squamous cell carcinoma surgery or radiation treatment at a non-MD Anderson institution
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial assessment period
Participants undergo evaluation for clinical, environmental, and genetic factors related to oral premalignancy and oral cancer.
1 to 2 visits depending on clinical evaluation needs
Duration - Up to 5 years
Participants are monitored to assess symptom progression, treatment response, toxicity, and quality of life over time.
Follow-up visits scheduled as part of routine clinical care
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
X
Xiao Zhao, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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