Clinical and Molecular Features of Oral Premalignancy and Oral Cancer

M.D. Anderson Cancer Center

Status

Enrolling

Conditions

Oral Cancer

Treatments

Behavioral: Radiation

Study type

Observational

Funder types

Other

Identifiers

NCT06550050

NCI-2024-06602 (Other Identifier)

2024-0307

Details and patient eligibility

About

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.

Full 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)

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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: