Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550050
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Clinical and Molecular Features of Oral Premalignancy and Oral Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical and Molecular Features of Oral Premalignancy and Oral Cancer Associated With Tumor Initiation Aggressive Behavior Treatment Response and Survival Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 patients response to treatment
To identify and validate clinical and molecular prognostic markers that may predict a patients 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 patients 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 treatments
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 patients response to treatment
To identify and validate clinical and molecular prognostic markers that may predict a patients 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 patients 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 treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None