MicroRNA Markers in Head and Neck Cancers

NCT04305366 | Active Not Recruiting DMC

• 2 other identifiers: 12-1328.ccP30CA046934
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Squamous Cell Carcinoma of Head and Neck

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Tissue collection OTHER

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

Head and Neck Cancers

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fine needle aspiration biopsy, blood, and saliva specimens. DNA will be isolated from tissue samples obtained and this DNA will be treated with Bisulfite and we will use the SBYR Green Florescent labeling system in conjunction with real-time quantitative PCR.

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Tissue Banks

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Specimen Banks; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Shi-Long Lu, MD PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: March 12, 2020
• Study Start: November 16, 2012
• Primary Completion: December 20, 2022
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)