Recruiting

Oral Premalignancy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06550050

Conditions

Oral Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiation

Study Details

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.

Conditions

Oral Cancer

Study ID

NCT06550050

Start date

Oct 31, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2066

Anticipated

Primary completion date

Dec 31, 2064

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Clinical and molecular features of oral premalignancy and oral cancer

Interventions

Radiation

Standard of care

Primary outcome measure

  • MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) [ Time Frame: up to 5 years ]

Central Contacts and Locations

Central contacts

Xiao Zhao, MD

(713) 679-8704xzhao6@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Xiao Zhao, MD

713-679-8704xzhao6@mdanderson.org

Xiao Zhao, MD

(713) 679-8704xzhao6@mdanderson.org

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-16.