MicroRNA Markers in Head and Neck Cancers

NCT ID: NCT04305366

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-16

Study Completion Date

2026-02-28

Brief Summary

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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

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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.

Conditions

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Squamous Cell Carcinoma of Head and Neck

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Tissue collection

Intervention Type OTHER

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

Interventions

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Tissue collection

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shi-Long Lu, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Cancer Center

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA046934

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12-1328.cc

Identifier Type: -

Identifier Source: org_study_id

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