NCT06550050 Clinical and Molecular Features of Oral Premalignancy and Oral Cancer
| NCT ID | NCT06550050 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Oral Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-10-31 |
| Primary Completion | 2064-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-10-31 with a primary completion date of 2064-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06550050 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oral Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06550050 currently recruiting?
Yes, NCT06550050 is actively recruiting participants. Contact the research team at xzhao6@mdanderson.org for enrollment information.
Where is the NCT06550050 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06550050 clinical trial?
NCT06550050 is sponsored by M.D. Anderson Cancer Center. The trial plans to enroll 1,000 participants.
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