CancerNCT04599309
Real-time Detection of ctDNA and/or HPV DNA in High-risk Locally-advanced Head and Neck Squamous Cell Carcinoma
An observational study of Cancer and Head and Neck Squamous Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This research study will include patients with high risk locally advanced head and neck squamous cell carcinoma (LA-HNSCC) of the oral cavity, oropharynx, hypopharynx or larynx and patients that are starting on standard definitive treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2020to 30 Jun 2026
- 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 a diagnosis of high risk locally advanced head and neck squamous cell carcinoma (LA-HNSCC) of the oral cavity, oropharynx, hypopharynx or larynx and patients that are starting on standard definitive treatment.
Who may be able to join
- Histologically or cytological confirmed LA-HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx.
- Stage III HPV Positive or Stage III-IV HPV negative.
- Availability of tumor sample
- Patients who are candidates for standard definitive treatment defined as:
- Surgery followed by radiotherapy +/- chemotherapy OR
- Definite radiotherapy OR
- Definite chemoradiotherapy.
Who cannot join
- Early stage HNSCC (I and II)
- Distant metastatic HNSCC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-time Detection of ctDNA and/or HPV DNA in High-risk Locally-advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC): The Pre-MERIDIAN (Molecular Residual Disease Interception in High-risk LA-HNSCC) Study.
This research study will include patients with high risk locally advanced head and neck squamous cell carcinoma (LA-HNSCC) of the oral cavity, oropharynx, hypopharynx or larynx and patients that are starting on standard definitive treatment. Patients with both stage III HPV positive and stage III HPV negative will be included. In this study, we aim to evaluate feasibility of ctDNA and/or HPV DNA detection in real time in high-risk LA-HNSCC.
Read the detailed description
PRE-MERIDIAN aims to study the kinetics of ctDNA and HPV DNA after standard treatment in high-risk LA-HNSCC patients. This is an important study to understand their role in detecting MRD and determine optimal timing for ctDNA and HPV DNA quantification for future studies in immunotherapy.
We hypothesize that HPV DNA (in HPV+) +/- ctDNA detection in plasma after standard therapy may be quantified and monitored as MRD in high risk LA-HNSCC patients. We further hypothesize that detection of MRD in high risk LA-HNSCC after standard therapy may predict recurrence. Finally, we hypothesize that ctDNA time-to-clearance will be longer than 4-6 weeks after the end of treatment in some LA-HNSCC patients and therefore MRD may be further tested at 8-10 weeks after the end of standard therapy
- Keywords
- Kinetics of ctDNA, Kinetics of HPV DNA, High-risk LA-HNSCC, Liquid Biopsy, Head and Neck, Molecular Profiling, Advanced Cancer
- Medical subject headings
- Neoplasms, Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PRE-MERIDIAN | Patients with a histological or cytological diagnosis of LA-HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx (stage III HPV positive or stage III-IV HPV negative). Patients who are candidates for standard definitive treatment such as surgery followed by radiotherapy +/- chemotherapy, or definite radiotherapy, or definite chemoradiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of high-risk LA-HNSCC patients with successful detection of ctDNA and/or HPV DNA in real time
ctDNA will be detected using Cancer Personalized Profiling by deep Sequencing (CAPP-Seq), a personalized bespoke NGS assay, or a similar approach. HPV DNA will be measured using digital PCR (dPCR) in all plasma samples from HPV+ LA-HNSCC patients included in this study.
Measured: Through study completion, up to 2 years
Secondary outcomes (3)
Correlation of presence of ctDNA +/- HPV DNA after standard treatment with shorter relapse-free survival (RFS), as assessed by comparison of baseline ctDNA +/- HPV DNA detection with time to relapse
ctDNA will be detected using Cancer Personalized Profiling by deep Sequencing (CAPP-Seq), a personalized bespoke NGS assay, or a similar approach. HPV DNA will be measured using digital PCR (dPCR) in all plasma samples from HPV+ LA-HNSCC patients included in this study.
Measured: Through study completion, up to 2 years
Change in kinetics of ctDNA and/or HPV DNA over time after the end of standard definitive treatment and at recurrence, as assessed by ctDNA/HPV DNA analysis at sequential time points.
To provide preliminary data on the role of ctDNA and HPV DNA on detecting MRD in high-risk LA-HNSCC patients after standard treatment.
Measured: Through study completion, up to 2 years
Selection of the best time-point to detect MRD after standard definitive therapy in HNSCC, as assessed by comparison of quantified ctDNA +/- HPV DNA at 4-6 weeks vs 8-10 weeks.
To provide preliminary data on the role of ctDNA and HPV DNA on detecting MRD in high-risk LA-HNSCC patients after standard treatment.
Measured: Through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start15 Oct 2020
- Primary completion31 Mar 2023
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Lillian Siu, Principal investigator, Princess Margaret Cancer CentreScott Bratman, Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599309
- Sponsor's protocol ID
- PRE-MERIDIAN
- Other IDs
- 20-5804
- Status last verified
- Jun 2026
- First submitted
- 18 Oct 2020
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Targeted gene sequencing results, along with limited clinical information that does not identify the patient as an individual, such as age, partial date of birth (year, month), gender, cancer type, and pathology information related to the samples tested, and survival time may be shared with collaborating researchers. Data from this study can be shared through two types of databases: open-access or controlled-access. An open-access database is publicly accessible and contains limited clinical information and analyses of samples. A controlled-access database contains more detailed clinical information, such as relevant past medical history and the results of prior and ongoing cancer treatments, and analyses of samples, but is only accessible to researchers who sign agreements defining how data may be used. All data will be stripped of all personal identifying information.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Detection of ctDNA and/or HPV DNA in High-risk Locally-advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC): The Pre-MERIDIAN (Molecular Residual Disease Interception in High-risk LA-HNSCC) Study.
- ClinicalTrials.gov ID
- NCT04599309
- Acronym / sponsor ID
- PRE-MERIDIAN
- Keywords
- Kinetics of ctDNA, Kinetics of HPV DNA, High-risk LA-HNSCC, Liquid Biopsy, Head and Neck, Molecular Profiling, Advanced Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Oct 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.
This research study will include patients with high risk locally advanced head and neck squamous cell carcinoma (LA-HNSCC) of the oral cavity, oropharynx, hypopharynx or larynx and patients that are starting on standard definitive treatment. Patients with both stage III HPV positive and stage III HPV negative will be included. In this study, we aim to evaluate feasibility of ctDNA and/or HPV DNA detection in real time in high-risk LA-HNSCC.
Detailed description
PRE-MERIDIAN aims to study the kinetics of ctDNA and HPV DNA after standard treatment in high-risk LA-HNSCC patients. This is an important study to understand their role in detecting MRD and determine optimal timing for ctDNA and HPV DNA quantification for future studies in immunotherapy.
We hypothesize that HPV DNA (in HPV+) +/- ctDNA detection in plasma after standard therapy may be quantified and monitored as MRD in high risk LA-HNSCC patients. We further hypothesize that detection of MRD in high risk LA-HNSCC after standard therapy may predict recurrence. Finally, we hypothesize that ctDNA time-to-clearance will be longer than 4-6 weeks after the end of treatment in some LA-HNSCC patients and therefore MRD may be further tested at 8-10 weeks after the end of standard therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRE-MERIDIAN | – | –Patients with a histological or cytological diagnosis of LA-HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx (stage III HPV positive or stage III-IV HPV negative). Patients who are candidates for standard definitive treatment such as surgery followed by radiotherapy +/- chemotherapy, or definite radiotherapy, or definite chemoradiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of high risk locally advanced head and neck squamous cell carcinoma (LA-HNSCC) of the oral cavity, oropharynx, hypopharynx or larynx and patients that are starting on standard definitive treatment.
Key inclusion criteria (7 listed)
- Histologically or cytological confirmed LA-HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx.
- Stage III HPV Positive or Stage III-IV HPV negative.
- Availability of tumor sample
- Patients who are candidates for standard definitive treatment defined as:
- Surgery followed by radiotherapy +/- chemotherapy OR
Key exclusion criteria (2 listed)
- Early stage HNSCC (I and II)
- Distant metastatic HNSCC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of high-risk LA-HNSCC patients with successful detection of ctDNA and/or HPV DNA in real time
Time frame: Through study completion, up to 2 years
ctDNA will be detected using Cancer Personalized Profiling by deep Sequencing (CAPP-Seq), a personalized bespoke NGS assay, or a similar approach. HPV DNA will be measured using digital PCR (dPCR) in all plasma samples from HPV+ LA-HNSCC patients included in this study.
3 secondary outcomes
Correlation of presence of ctDNA +/- HPV DNA after standard treatment with shorter relapse-free survival (RFS), as assessed by comparison of baseline ctDNA +/- HPV DNA detection with time to relapse
Time frame: Through study completion, up to 2 years
Change in kinetics of ctDNA and/or HPV DNA over time after the end of standard definitive treatment and at recurrence, as assessed by ctDNA/HPV DNA analysis at sequential time points.
Time frame: Through study completion, up to 2 years
Selection of the best time-point to detect MRD after standard definitive therapy in HNSCC, as assessed by comparison of quantified ctDNA +/- HPV DNA at 4-6 weeks vs 8-10 weeks.
Time frame: Through study completion, up to 2 years
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 10 Jun 2026.
- Individual participant dataSharing planned: Undecided. Targeted gene sequencing results, along with limited clinical information that does not identify the patient as an individual, such as age, partial date of birth (year, month), gender, cancer type, and pathology information related to the samples tested, and survival time may be shared with collaborating researchers. Data from this study can be shared through two types of databases: open-access or controlled-access. An open-access database is publicly accessible and contains limited clinical information and analyses of samples. A controlled-access database contains more detailed clinical information, such as relevant past medical history and the results of prior and ongoing cancer treatments, and analyses of samples, but is only accessible to researchers who sign agreements defining how data may be used. All data will be stripped of all personal identifying information.
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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.
Lillian Siu principal investigator
Princess Margaret Cancer Centre
Scott Bratman principal investigator
Princess Margaret Cancer Centre
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 Cancer and Head and Neck Squamous Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
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 7 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 10 Jun 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 Canada. 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?
Number of high-risk LA-HNSCC patients with successful detection of ctDNA and/or HPV DNA in real time (time frame: Through study completion, up to 2 years). 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 10 Jun 2026.