MicroRNA Markers in Head and Neck Cancers

Squamous Cell Carcinoma of Head and Neck Clinical Trial

Official title:

MicroRNA Markers in Head and Neck Cancers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04305366
• Other study ID #: 12-1328.cc
• Secondary ID: P30CA046934
• Status: Active, not recruiting
• Start date: November 16, 2012
• Est. completion date: February 2026

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 225
• Est. completion date: February 2026
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Squamous Cell Carcinoma of Head and Neck

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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