Clinical and Molecular Features of Oral Premalignancy and Oral Cancer
NCT ID: NCT06550050
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2024-10-31
2066-12-31
Brief Summary
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Detailed Description
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* 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)
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Clinical and molecular features of oral premalignancy and oral cancer
Radiation
Standard of care
Interventions
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Radiation
Standard of care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Locations
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MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2024-06602
Identifier Type: OTHER
Identifier Source: secondary_id
2024-0307
Identifier Type: -
Identifier Source: org_study_id
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