MicroRNA Markers in Head and Neck Cancers

The purpose of this study is to investigate the presence of miRNA markers in saliva, blood, FNA and tissue specimens in patients with and without head and neck cancer and evaluate whether these miRNA markers can provide prognostic or diagnostic clinical significance in the treatment of head and neck cancer patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Squamous Cell Carcinoma of Head and Neck
• Intervention / Treatment: Other: Tissue collection

Detailed Description

Micro RNA (miRNA) markers were initially discovered in 1993 and recent research has shown that they have great potential for use as both surveillance and prognostic markers in cancer treatment, as well as potential targets for cancer therapy. Recent research has identified several miRNA markers which appear to be potential markers for head and neck squamous cell carcinoma, and these have been tested in both mouse and human banked tumor samples. These investigators hypothesize that these markers may also be present in other tissues, including fine needle aspiration biopsy, blood, and saliva specimens, and will be sensitive and specific to patients with known head and neck cancer.

• Study Type: Observational
• Enrollment (Actual): 225

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Up to 500 patients will be enrolled in this study. Subjects to be enrolled in this study will already have a clinical relationship with a professional in the adult ENT clinic at University of Colorado Hospital.

This study will target patients with a diagnosis squamous cell carcinoma in the head and neck. In addition, this study will also target patients undergoing tonsillectomy or sleep surgery as the control group. This study will aim to enroll an equal number of patients into both the study group and control group. However, this will be dependent on patient encounters within the adult ENT clinic.

Description

Inclusion Criteria:

1. Subjects between the ages of 18 and 100
2. Patients who are seen and evaluated by a provider within the adult ENT clinic at University of Colorado Hospital
3. Patients that present with a current or past diagnosis of head and neck cancer -OR-Patients undergoing tonsillectomy or sleep surgery as standard of care (control group)

Exclusion Criteria:

1. Under the age of 18 or over the age of 100
2. Unwilling to participate

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Head and Neck Cancers; This study will target patients with a diagnosis squamous cell carcinoma in the head and neck. In addition, this study will also target patients undergoing tonsillectomy or sleep surgery as the control group. This study will aim to enroll an equal number of patients into both the study group and control group. However, this will be dependent on patient encounters within the adult ENT clinic.

Other: Tissue collection; Blood draw, Fine Needle Aspiration, Saliva Swab, Tumor/tissue sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate the miRNA signature of samples	Tissue samples will be obtained and DNA will be isolated from those samples. DNA will be treated with Bisulfite and labelled with SBYR Green Florescent labeling system, in conjunction with real-time quantitative PCR for analysis. miRNA biomarkers idenfitied through PCR will be collected.	5 years
Develop biomarkers from fine needle aspiration biopsies and other specimens, using real-time PCR, for surveillance of HNSCC patients.	Fine needle aspiration (FNA) biopsies, saliva, serum and tumor samples will be collected from HNSCC patients and controls. Samples will undergo real-time PCR using miRNA biomarkers. The efficacy of these biomarkers will be collected, to determine the status of the Head/Neck Cancer as the study progresses	5 years

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Shi-Long Lu, MD PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2012
• Primary Completion (Actual): December 20, 2022
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Health Care Facilities Workforce and Services; Biological Specimen Banks; Health Facilities; Tissue Banks
• Other Study ID Numbers: 12-1328.cc; P30CA046934 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No