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MicroRNA Markers in Head and Neck Cancers

MicroRNA Markers in Head and Neck Cancers

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04305366
Enrollment
225
Registered
2020-03-12
Start date
2012-11-16
Completion date
2027-02-01
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

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.

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.

Interventions

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

Sponsors

University of Colorado, Denver
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Investigate the miRNA signature of samples5 yearsTissue 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.5 yearsFine 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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORShi-Long Lu, MD PhD

University of Colorado, Denver

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026