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Real-time Detection of ctDNA and/or HPV DNA in High-risk Locally-advanced Head and Neck Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT04599309
Recruitment Status : Active, not recruiting
First Posted : October 22, 2020
Last Update Posted : April 15, 2022
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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Brief 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. 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.

Condition or disease
Cancer Head and Neck Squamous Cell Carcinoma Head and Neck Cancer

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
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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : October 15, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    To provide preliminary data on the role of ctDNA and HPV DNA on detecting MRD in high-risk LA-HNSCC patients after standard treatment.

  3. 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 ]
    To provide preliminary data on the role of ctDNA and HPV DNA on detecting MRD in high-risk LA-HNSCC patients after standard treatment.


Biospecimen Retention:   Samples With DNA
Blood samples collected serially for cfDNA and DNA extraction. Archived tumor sample collected for tumor genomic DNA analysis.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Early stage HNSCC (I and II)
  • Distant metastatic HNSCC
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04599309


Locations
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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, L1M2J2
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
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Principal Investigator: Lillian Siu Princess Margaret Cancer Centre
Principal Investigator: Scott Bratman Princess Margaret Cancer Centre
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04599309    
Other Study ID Numbers: PRE-MERIDIAN
20-5804 ( Other Identifier: CAPCR ID )
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Kinetics of ctDNA
Kinetics of HPV DNA
High-risk LA-HNSCC
Liquid Biopsy
 Head and Neck
Molecular Profiling
Advanced Cancer
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site