Clinical trial NCT06550050: Clinical and Molecular Features of Oral Premalignancy and Oral Cancer
Official title: Clinical and Molecular Features of Oral Premalignancy and Oral Cancer Associated With Tumor Initiation, Aggressive Behavior, Treatment Response, and Survival Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oral Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MD Anderson Cancer Center

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)

Eligibility 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:

* 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.

Primary outcomes:
measure: MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
timeFrame: up to 5 years
Secondary outcomes:
measure: M.D. Anderson Dysphagia Inventory (MDADI)
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References: