Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT06550050
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.
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)
Study:
NCT06550050
Study Brief:
Protocol Section:
NCT06550050