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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,000

participants targeted

Target at P75+ for all trials

Timeline

495mo left

Started Oct 2024

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

42.2 years study duration

Study Progress3%

Oct 2024Dec 2066

First Submitted

Initial submission to the registry

August 1, 2024

Completed

11 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed

3 months until next milestone

Study Start

First participant enrolled

October 31, 2024

Completed

40.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2064

Expected

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2066

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

40.2 years

First QC Date

August 1, 2024

Last Update Submit

April 13, 2026

Conditions

Oral Cancer

Outcome Measures

Primary Outcomes (1)

MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
The MDASI-HN is a patient-reported outcome questionnaire designed to measure the severity or burden of systemic and head- and neck-specific symptoms and their interference with or effect on patients' daily functioning (Rosenthal, Mendoza et al. 2007, Cleeland 2016). This 28-item multi-symptom inventory is rated according to the last 24 hours at their worst, with 0 being symptoms not present and 10 being as bad as the patient can imagine. Cronbach alpha reliability ranges from 0.72 to 0.92.
up to 5 years

Secondary Outcomes (1)

M.D. Anderson Dysphagia Inventory (MDADI)
up to 5 years

Study Arms (1)