Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Clinical and molecular features of oral premalignancy and oral cancer
- interventionNames
- Behavioral: Radiation
Primary outcomes (1)
- 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.
Secondary outcomes (1)
- measure
- M.D. Anderson Dysphagia Inventory (MDADI)
- timeFrame
- up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* 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.
References
Publications (0)
Data not yet available