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Recruiting OBSERVATIONAL NCT06550050

Clinical and Molecular Features of Oral Premalignancy and Oral Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Detailed Description

Primary objectives: Current primary objectives need revision as they focus on diabetes which is not the focus of this study. * Investigators will examine the role of clinical, environmental, and genetic factors in increasing the risk of developing oral cancers and aggressive oral cancers. * To identify important environmental and clinical factors contributing to the risk of developing oral cancer or cancer progression * To identify genetic and molecular factors which contribute to increased risk of developing oral cancers through analysis of germline and somatic genetic alterations * Investigators will identify clinical and molecular predictors of diagnosis, treatment response, toxicity, and outcomes in patients with oral tumors. * To identify and validate clinical and molecular prognostic markers that may predict a patient's response to treatment * To identify and validate clinical and molecular prognostic markers that may predict a patient's risk of developing toxicity related to various modalities of treatment including but not limited to: targeted therapy, chemotherapy, radiation, surgery, and immunotherapy * To identify and validate clinical and molecular prognostic markers that may predict a patient's prognosis * To determine whether clinical and treatment factors influence patients' quality of life as assessed by validated self-report instruments routinely incorporated into clinical care pathways * To identify and validate molecular markers that may improve the diagnosis of oral premalignant or malignant tumors * To characterize acute and long-term function and quality of life after curative treatment(s)

Interventions

Name: Radiation
Type: BEHAVIORAL
Description: Standard of care

Primary Outcomes

Measure: MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
TimeFrame: up to 5 years
Description: The MDASI-HN is a patient-reported outcome questionnaire designed to measure the severity or burden of systemic and head- and neck-specific symptoms and their interference with or effect on patients' daily functioning (Rosenthal, Mendoza et al. 2007, Cleeland 2016). This 28-item multi-symptom inventory is rated according to the last 24 hours at their worst, with 0 being symptoms not present and 10 being as bad as the patient can imagine. Cronbach alpha reliability ranges from 0.72 to 0.92.

Trial Information

NCT ID

NCT06550050

Status

Recruiting

Study Type

OBSERVATIONAL

Sponsor

M.D. Anderson Cancer Center

Last Updated

December 15, 2025