Squamous Cell Carcinoma of Head and NeckNCT04305366
MicroRNA Markers in Head and Neck Cancers
An observational study of Squamous Cell Carcinoma of Head and Neck, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Tissue collection
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2012to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Under the age of 18 or over the age of 100
- Unwilling to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Cancer Center
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- Tissue collection
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue collectionOther
Blood draw, Fine Needle Aspiration, Saliva Swab, Tumor/tissue sample
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Tissue collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start16 Nov 2012
- Primary completion20 Dec 2022
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shi-Long Lu, MD PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305366
- Sponsor's protocol ID
- 12-1328.cc
- Other IDs
- P30CA046934
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2020
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNA Markers in Head and Neck Cancers
- ClinicalTrials.gov ID
- NCT04305366
- Acronym / sponsor ID
- 12-1328.cc
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Nov 2012 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and Neck Cancers | – | Other: Tissue collectionThis 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Under the age of 18 or over the age of 100
- Unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue collectionBlood draw, Fine Needle Aspiration, Saliva Swab, Tumor/tissue sample | Other | Head and Neck Cancers |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shi-Long Lu, MD PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma of Head and Neck, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate the miRNA signature of samples (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.