Head and Neck NeoplasmNCT04099290
Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma
An observational study of Head and Neck Neoplasm and Carcinoma, Squamous Cell, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
Circulating tumor DNA (ctDNA) is a blood-based test that measures dying or dead cancer cells that are already circulating in the blood. In this study, the investigators will enroll patients who are planning to receive surgery to remove their head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasm, Carcinoma, Squamous Cell
- What is being tested?
- Blood and tumor samples
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2020to 1 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Head and Neck Cancer
Who may be able to join
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Consent for the use of any residual material from biopsy and/or surgical resection (archival tissue) and serial blood draws will be required for enrollment.
- Age ≥ 18 years of age on day of signing informed consent
- Newly diagnosed, histologically confirmed squamous cell carcinoma of the head and neck, including the following subtypes: oral cavity, oropharynx, larynx
- Must be planning to undergo gross total resection of the primary tumor with curative intent at UNC-CH hospital
- No prior, definitive therapy to primary tumor. Must meet one of the following clinical stages: T3-T4 (if T1/T2 must have nodal involvement), Any N, M0
- Patient must be amenable to receiving adjuvant therapy with radiotherapy +/- systemic therapy, as clinically indicated, based on either standard of care (SOC) or appropriate clinical trial.
- Diagnostic tumor material must be available for correlative analysis
- Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee
Who cannot join
- Has known evidence of metastatic disease based on clinical or radiographic studies
- Women who are pregnant or nursing
- History of another primary malignancy in the last 5 years prior to registration. Patients with history of in situ cancer or basal or localized squamous cell skin cancers are eligible.
- Patients with primary skin cancers of the head and neck, including basal or squamous cell cancers
- Prior chemotherapy, IP, biologic, or hormonal therapy for HNSCC treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Siddharth Sheth, MD, siddharth.sheth@unchealth.unc.edu
Rebecca Green, MSW, 984-974-8440, rlgreen@med.unc.edu
About this study
Circulating tumor DNA (ctDNA) is a blood-based test that measures dying or dead cancer cells that are already circulating in the blood. In this study, the investigators will enroll patients who are planning to receive surgery to remove their head and neck cancer. The investigators are interested to learn how ctDNA levels change with surgery and over the course of time. The investigators also want to determine if there are certain features of the tumor or the patient themselves that might cause ctDNA to be higher than other patients. Also, the investigators want to explore if the detection of ctDNA following surgery is related to cancer recurrence.
Read the detailed description
The investigators will take a piece of the tumor from the surgery and determine if they can identify mutations, or changes in the genetic makeup of the cells due to cancer, that are specific to the tumor. Based on this information, the investigators will design a test using PCR, which is a technology that allows for the amplification of the DNA, that is specific to the mutation identified in the tumor. Once verified, the presence (or absence) of ctDNA in the blood can be measured. The investigators will measure this blood test prior to surgery and at multiple time points following surgery. Specimens will be collected at the time of planned clinical assessments.
- Conditions
- Head and Neck Neoplasm, Carcinoma, Squamous Cell
- Being tested
- Blood and tumor samples
- Keywords
- Squamous Cell Carcinoma, Circulating Tumor DNA
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and tumor samplesOther
Blood samples to be obtained at consent, post-operatively, post-adjuvant treatment, and at follow-up or recurrence. Tumor samples to be obtained at surgery and at time of recurrence or post-treatment biopsy, if applicable.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of tumor-specific mutation in pre-operative circulating tumor DNA of patients with locally-advanced HNSCC who are receiving surgery for treatment of their primary tumor
Measured: Time of consent
Secondary outcomes (5)
Rate of tumor-specific mutation in post-operative circulating tumor DNA in patients with locally-advanced HNSCC who received surgery for treatment of their primary tumor
Measured: Post-surgery/pre-treatment, post-surgery/post-treatment (approximately 6 weeks following initiation of treatment and every 3 months up to 2 years), and at disease recurrence if applicable (up to 5 years)
Change in ctDNA levels (i.e., copies per mL plasma) over time
Measured: Time of consent, post-operatively (approximately 1-4 weeks after surgery), post-adjuvant treatment (approximately 6 weeks following initiation of treatment) and follow-up (every 3 months up to 2 years)/recurrence if applicable (up to 5 years)
Description of tumor-specific mutations in surgical specimens by NGS
Measured: Surgery and post-treatment biopsy/recurrence if applicable(up to 5 years)
Correlation between post-operative plasma ctDNA levels and surgical margins
Measured: Post-operatively (approximately 1-4 weeks after surgery)
Correlation between post-operative plasma ctDNA levels and extra-capsular extension
Measured: Post-operatively (approximately 1-4 weeks after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start14 Jan 2020
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Clinical Oncology, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Siddharth Sheth, MD, Principal investigator, UNC Health CareGaorav Gupta, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099290
- Sponsor's protocol ID
- LCCC 1835
- Other IDs
- 5K12CA120780-15
- Status last verified
- Feb 2026
- First submitted
- 17 Sep 2019
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04099290
- Acronym / sponsor ID
- LCCC 1835
- Conditions
- Head and Neck Neoplasm, Carcinoma, Squamous Cell
- Keywords
- Squamous Cell Carcinoma, Circulating Tumor DNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- American Society of Clinical Oncology, National Cancer Institute (NCI)
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 23 Sep 2019 (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.
Circulating tumor DNA (ctDNA) is a blood-based test that measures dying or dead cancer cells that are already circulating in the blood. In this study, the investigators will enroll patients who are planning to receive surgery to remove their head and neck cancer. The investigators are interested to learn how ctDNA levels change with surgery and over the course of time. The investigators also want to determine if there are certain features of the tumor or the patient themselves that might cause ctDNA to be higher than other patients. Also, the investigators want to explore if the detection of ctDNA following surgery is related to cancer recurrence.
Detailed description
The investigators will take a piece of the tumor from the surgery and determine if they can identify mutations, or changes in the genetic makeup of the cells due to cancer, that are specific to the tumor. Based on this information, the investigators will design a test using PCR, which is a technology that allows for the amplification of the DNA, that is specific to the mutation identified in the tumor. Once verified, the presence (or absence) of ctDNA in the blood can be measured. The investigators will measure this blood test prior to surgery and at multiple time points following surgery. Specimens will be collected at the time of planned clinical assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Head and Neck Cancer
Key inclusion criteria (8 listed)
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Consent for the use of any residual material from biopsy and/or surgical resection (archival tissue) and serial blood draws will be required for enrollment.
- Age ≥ 18 years of age on day of signing informed consent
- Newly diagnosed, histologically confirmed squamous cell carcinoma of the head and neck, including the following subtypes: oral cavity, oropharynx, larynx
- Must be planning to undergo gross total resection of the primary tumor with curative intent at UNC-CH hospital
- No prior, definitive therapy to primary tumor. Must meet one of the following clinical stages: T3-T4 (if T1/T2 must have nodal involvement), Any N, M0
Key exclusion criteria (5 listed)
- Has known evidence of metastatic disease based on clinical or radiographic studies
- Women who are pregnant or nursing
- History of another primary malignancy in the last 5 years prior to registration. Patients with history of in situ cancer or basal or localized squamous cell skin cancers are eligible.
- Patients with primary skin cancers of the head and neck, including basal or squamous cell cancers
- Prior chemotherapy, IP, biologic, or hormonal therapy for HNSCC treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
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 |
|---|---|---|
| Blood and tumor samplesBlood samples to be obtained at consent, post-operatively, post-adjuvant treatment, and at follow-up or recurrence. Tumor samples to be obtained at surgery and at time of recurrence or post-treatment biopsy, if applicable. | Other | – |
Primary outcome
Rate of tumor-specific mutation in pre-operative circulating tumor DNA of patients with locally-advanced HNSCC who are receiving surgery for treatment of their primary tumor
Time frame: Time of consent
5 secondary outcomes
Rate of tumor-specific mutation in post-operative circulating tumor DNA in patients with locally-advanced HNSCC who received surgery for treatment of their primary tumor
Time frame: Post-surgery/pre-treatment, post-surgery/post-treatment (approximately 6 weeks following initiation of treatment and every 3 months up to 2 years), and at disease recurrence if applicable (up to 5 years)
Change in ctDNA levels (i.e., copies per mL plasma) over time
Time frame: Time of consent, post-operatively (approximately 1-4 weeks after surgery), post-adjuvant treatment (approximately 6 weeks following initiation of treatment) and follow-up (every 3 months up to 2 years)/recurrence if applicable (up to 5 years)
Description of tumor-specific mutations in surgical specimens by NGS
Time frame: Surgery and post-treatment biopsy/recurrence if applicable(up to 5 years)
Correlation between post-operative plasma ctDNA levels and surgical margins
Time frame: Post-operatively (approximately 1-4 weeks after surgery)
Correlation between post-operative plasma ctDNA levels and extra-capsular extension
Time frame: Post-operatively (approximately 1-4 weeks after surgery)
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 6 Feb 2026.
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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.
Siddharth Sheth, MD principal investigator
UNC Health Care
Gaorav Gupta, MD principal investigator
University of North Carolina, Chapel Hill
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 Head and Neck Neoplasm and Carcinoma, Squamous Cell, run by UNC Lineberger Comprehensive Cancer Center 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 8 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 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?
Contact Siddharth Sheth, MD ((919) 966-3856, Siddharth.Sheth@unchealth.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of tumor-specific mutation in pre-operative circulating tumor DNA of patients with locally-advanced HNSCC who are receiving surgery for treatment of their primary tumor (time frame: Time of consent). 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 6 Feb 2026.