Squamous Cell Carcinoma of Head and NeckMRD-DUCHESSNCT06744296
Measurable Residual Disease Detection Using Tumor-Informed ctDNA Surveillance After Curative-Intent Treatment in HPV-Independent Squamous Cell Carcinoma of the Head and Neck
An observational study of Squamous Cell Carcinoma of Head and Neck, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
This study will test the ability of a personalized blood test to determine which head and neck cancer patients will have a recurrence after treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Blood Draws and Tissue Sample(s)
- Type of treatment
- Pill or oral medicine
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to 6 Jan 2029
- 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 Stage III-IVB mucosal squamous cell carcinoma of the head and neck
Who may be able to join
- Newly diagnosed AJCC 8th edition Stage III-IVB mucosal SCC of the head and neck, which includes tumors arising from the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx, and larynx.
- Available tissue for tumor-informed ctDNA panel creation.
- Definitive treatment with standard of care surgery or chemoradiotherapy is planned to be administered at Massachusetts Eye and Ear Institute (MEEI) or within the Massachusetts General Hospital (MGH) Cancer Center (including but not limited to the Boston, Danvers, and Newton-Wellesley locations).
Who cannot join
- Patients <18 years of age
- Patients receiving non-standard of care therapy as determined by the clinical investigator
- Participants who have undergone prior surgical resection, excisional biopsy, radiation, and/or chemotherapy for the treatment of HNSCC. Prior incisional biopsies are permitted. Discrepant cases will be reviewed by study PI.
- Participants who are receiving any investigational agents at the time of enrollment.
- Participants with AJCC Stage IVC HNSCC, which includes patients with biopsy-confirmed distant metastatic HNSCC, including but not limited to metastatic spread to the lungs, bones, or liver.
- Active non-HNSCC malignancy.
- Active pregnancy during treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gyjstina Lumaj contact
United States1 site, 1 recruiting
- Recruiting
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
Michael Cheung, MSc, CCRP, 617-573-6060, mcheung0@meei.harvard.edu
Gjystina Lumaj, glumaj@meei.harvard.edu
About this study
This study will test the ability of a personalized blood test to determine which head and neck cancer patients will have a recurrence after treatment.
Read the detailed description
This is a two-arm, prospective, observational study of patients with human papillomavirus (HPV)-independent head and neck squamous cell carcinoma (HNSCC) who are receiving curative-intent treatment. Arm 1 will consist of patients who undergo surgery. Arm 2 will consist of patients who undergo chemoradiotherapy.
The study will test the following hypotheses:
- That applying a tumor-informed minimal residual disease (MRD) assay after completion of curative-intent treatment will accurately discriminate between patients who will eventually experience recurrence (those are MRD positive) and patients who will remain disease-free (those who are MRD negative). The hypothesis is that patients who have detectable ctDNA following treatment-MRD positive patients-will experience recurrent disease within 2 years, while patients who have no detectable ctDNA-MRD negative patients-will remain disease free at 2 years.
- That measuring MRD after completion of curative-intent treatment will provide a lead time from detectable to clinical diagnosis of recurrent disease of at least 3 months.
The primary outcome is 2-year DFS in patients with detectable vs no detectable ctDNA two weeks after treatment completion.
The study will accrue 75 patients, who will be followed for a minimum of 2 years.
Subjects will have blood draws before, during and following treatment at regular intervals for testing with the assay (Haystack MRD™)
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- Blood Draws and Tissue Sample(s)
- 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.
Blood Draws and Tissue Sample(s)Other
All participants on the study, regardless of arm, will be getting blood draws, and tissue samples.
| Study group | Role | What they receive |
|---|---|---|
| Patients Receiving only Surgery | Patients in this group will only be those who receive surgery, and does not receive radiographic testing or chemotherapy. Receives: Other: Blood Draws and Tissue Sample(s) | |
| Patients receiving chemoradiotherapy | * Newly diagnosed AJCC 8th edition Stage III-IVB mucosal SCC of the head and neck, which includes tumors arising from the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx, and larynx.
* Available tissue for tumor-informed ctDNA panel creation.
* Definitive treatment with standard of care surgery (arm 1) or chemoradiotherapy (arm 2) Receives: Other: Blood Draws and Tissue Sample(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 Years - Disease Free Survival (DFS)
2-year disease-free survival (DFS) in patients with detectable vs no detectable ctDNA two weeks after treatment completion
Measured: 2 weeks after treatment completion
Secondary outcomes (3)
2 Years - Overall Survival (OS)
2-year overall survival (OS) in patients with detectable vs no detectable ctDNA two weeks after treatment completion
Measured: 2 weeks after treatment completion
2 Years - Disease Free Survival (DFS) and Overall Survival (OS)
2-year disease-free survival (DFS) and overall survival (OS) in patients with detectable vs no detectable ctDNA four weeks after treatment completion
Measured: 4 weeks after treatment completion
2 - Years Disease Free Survival (DFS) and Overall Survival (OS)
2-year disease-free survival (DFS) and overall survival (OS) in patients with detectable vs no detectable ctDNA six weeks after treatment completion
Measured: 6 week after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start3 Feb 2025
- Primary completion6 Jan 2027 (estimated)
- Study completion6 Jan 2029 (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.
- 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- Haystack Oncology, Inc.
- Responsible party
- Principal investigator, Daniel L. Faden, MD, Massachusetts General Hospital
- Investigators
- Daniel Faden, MD, Principal investigator, Massachusetts Eye and Ear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744296
- Sponsor's protocol ID
- 2024P002675
- Acronym
- MRD-DUCHESS
- Status last verified
- May 2025
- First submitted
- 9 Dec 2024
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurable Residual Disease Detection Using Tumor-Informed ctDNA Surveillance After Curative-Intent Treatment in HPV-Independent Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT06744296
- Acronym / sponsor ID
- MRD-DUCHESS / 2024P002675
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Collaborators
- Haystack Oncology, Inc.
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 6 Jan 2027 (estimated)
- Study completion
- 6 Jan 2029 (estimated)
- First posted
- 20 Dec 2024 (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.
This study will test the ability of a personalized blood test to determine which head and neck cancer patients will have a recurrence after treatment.
Detailed description
This is a two-arm, prospective, observational study of patients with human papillomavirus (HPV)-independent head and neck squamous cell carcinoma (HNSCC) who are receiving curative-intent treatment. Arm 1 will consist of patients who undergo surgery. Arm 2 will consist of patients who undergo chemoradiotherapy.
The study will test the following hypotheses:
- That applying a tumor-informed minimal residual disease (MRD) assay after completion of curative-intent treatment will accurately discriminate between patients who will eventually experience recurrence (those are MRD positive) and patients who will remain disease-free (those who are MRD negative). The hypothesis is that patients who have detectable ctDNA following treatment-MRD positive patients-will experience recurrent disease within 2 years, while patients who have no detectable ctDNA-MRD negative patients-will remain disease free at 2 years.
- That measuring MRD after completion of curative-intent treatment will provide a lead time from detectable to clinical diagnosis of recurrent disease of at least 3 months.
The primary outcome is 2-year DFS in patients with detectable vs no detectable ctDNA two weeks after treatment completion.
The study will accrue 75 patients, who will be followed for a minimum of 2 years.
Subjects will have blood draws before, during and following treatment at regular intervals for testing with the assay (Haystack MRD™)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving only Surgery | – | Other: Blood Draws and Tissue Sample(s)Patients in this group will only be those who receive surgery, and does not receive radiographic testing or chemotherapy. |
| Patients receiving chemoradiotherapy | – | Other: Blood Draws and Tissue Sample(s)* Newly diagnosed AJCC 8th edition Stage III-IVB mucosal SCC of the head and neck, which includes tumors arising from the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx, and larynx. * Available tissue for tumor-informed ctDNA panel creation. * Definitive treatment with standard of care surgery (arm 1) or chemoradiotherapy (arm 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Stage III-IVB mucosal squamous cell carcinoma of the head and neck
Key inclusion criteria (3 listed)
- Newly diagnosed AJCC 8th edition Stage III-IVB mucosal SCC of the head and neck, which includes tumors arising from the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx, and larynx.
- Available tissue for tumor-informed ctDNA panel creation.
- Definitive treatment with standard of care surgery or chemoradiotherapy is planned to be administered at Massachusetts Eye and Ear Institute (MEEI) or within the Massachusetts General Hospital (MGH) Cancer Center (including but not limited to the Boston, Danvers, and Newton-Wellesley locations).
Key exclusion criteria (7 listed)
- Patients <18 years of age
- Patients receiving non-standard of care therapy as determined by the clinical investigator
- Participants who have undergone prior surgical resection, excisional biopsy, radiation, and/or chemotherapy for the treatment of HNSCC. Prior incisional biopsies are permitted. Discrepant cases will be reviewed by study PI.
- Participants who are receiving any investigational agents at the time of enrollment.
- Participants with AJCC Stage IVC HNSCC, which includes patients with biopsy-confirmed distant metastatic HNSCC, including but not limited to metastatic spread to the lungs, bones, or liver.
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 Draws and Tissue Sample(s)All participants on the study, regardless of arm, will be getting blood draws, and tissue samples. | Other | Patients Receiving only Surgery, Patients receiving chemoradiotherapy |
Primary outcome
2 Years - Disease Free Survival (DFS)
Time frame: 2 weeks after treatment completion
2-year disease-free survival (DFS) in patients with detectable vs no detectable ctDNA two weeks after treatment completion
3 secondary outcomes
2 Years - Overall Survival (OS)
Time frame: 2 weeks after treatment completion
2 Years - Disease Free Survival (DFS) and Overall Survival (OS)
Time frame: 4 weeks after treatment completion
2 - Years Disease Free Survival (DFS) and Overall Survival (OS)
Time frame: 6 week after treatment completion
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 18 May 2025.
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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.
Gyjstina Lumaj contact
Daniel Faden, MD principal investigator
Massachusetts Eye and Ear
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 Massachusetts Eye and Ear Infirmary 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 7 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 18 May 2025. 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 Michael Cheung, MSc, CCRP (617-573-6060, mcheung0@meei.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 Years - Disease Free Survival (DFS) (time frame: 2 weeks after treatment completion). 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 18 May 2025.