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Trial Title:
Clinical and Molecular Features of Oral Premalignancy and Oral Cancer
NCT ID:
NCT06550050
Condition:
Oral Cancer
Conditions: Official terms:
Mouth Neoplasms
Lip Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Behavioral
Intervention name:
Radiation
Description:
Standard of care
Arm group label:
Clinical and molecular features of oral premalignancy and oral cancer
Other name:
Chemotherapy
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)
Criteria for eligibility:
Study pop:
MD Anderson Cancer Center
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Xiao Zhao, MD
Phone:
713-679-8704
Email:
xzhao6@mdanderson.org
Contact backup:
Last name:
Xiao Zhao, MD
Phone:
(713) 679-8704
Email:
xzhao6@mdanderson.org
Start date:
October 31, 2024
Completion date:
December 31, 2066
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06550050
http://www.mdanderson.org
