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

NCT04599309 | Active Not Recruiting

• 2 other identifiers: PRE-MERIDIAN20-5804
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma

Keywords

Kinetics of ctDNA; Kinetics of HPV DNA; High-risk LA-HNSCC; Liquid Biopsy; Head and Neck; Molecular Profiling; Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

  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.

  Through study completion, up to 2 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Early stage HNSCC (I and II)
• Distant metastatic HNSCC

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, L1M2J2, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples collected serially for cfDNA and DNA extraction. Archived tumor sample collected for tumor genomic DNA analysis.

MeSH Terms

Conditions

Neoplasms; Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms by Site

Study Officials

• Lillian Siu

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

• Scott Bratman

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: October 22, 2020
• Study Start: October 15, 2020
• Primary Completion: March 31, 2023
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

CA (1)