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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Squamous Cell Carcinoma of Head and Neck Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects between the ages of 18 and 100
Patients who are seen and evaluated by a provider within the adult ENT clinic at University of Colorado Hospital
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

Under the age of 18 or over the age of 100
Unwilling to participate

Treatment and study plan

Tissue collection

Other

Blood draw, Fine Needle Aspiration, Saliva Swab, Tumor/tissue sample

Primary outcomes

Investigate the miRNA signature of samples

Time frame: 5 years

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.
Develop biomarkers from fine needle aspiration biopsies and other specimens, using real-time PCR, for surveillance of HNSCC patients.

Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Important dates

Study start: 2012
Primary completion: 2022
Study completion: 2027
First posted: Mar 12, 2020
Registry last updated: Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting