A study to investigate HPV-detect, a new way to measure the response to treatment in patients with Human Papilloma Virus (HPV) positive head and neck cancer

Investigation of novel plasma Human Papilloma Virus DNA assay for treatment response estimation in head and neck cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN32335415

Enrollment

191

Registered

2020-03-03

Start date

2020-01-10

Completion date

Unknown

Last updated

2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck cancer Cancer

Interventions

INOVATE is a multicentre prospective biological sample collection and analysis study which aims to validate circulating Human Papilloma Virus (HPV) DNA as a marker of residual disease in patients with

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or above. 2. Newly diagnosed patients with T1-T2/N1-3 or T3-T4/ N0-3 squamous cell carcinoma of the oropharynx 3. Availability of tissue from one archival diagnostic tumour tissue block 4. Confirmed HPV status (p16InK4A IHC/ISH) 5. Patients must be candidates for and willing to undergo curative RT/CRT 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Previous or concurrent illness or situation, which in the investigator’s opinion would interfere with collection of the complete sample collection 2. Any invasive malignancy within previous 5 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ 3. Clinical evidence of metastatic disease

Design outcomes

Primary

Measure	Time frame
The specificity of HPV-detect (using plasma HPV DNA levels) in correctly identifying those with no residual disease, at 3 months following completion of primary RT/CRT; defined as the proportion of patients who are HPV-detect negative among those with no residual disease according to 18F-FDG PET at the same timepoint.	—

Secondary

Measure	Time frame
1. The sensitivity of HPV-detect (using plasma HPV DNA levels) in correctly identifying those with residual disease at 3 months following completion of primary RT/CRT; defined as the proportion of patients who are HPV-detect positive among those with residual disease according to 18F-FDG PET-CT at the same timepoint 2. The proportion of patients who have no residual disease on biopsy/neck dissection amongst those with residual disease according to 18F FDG PET-CT but HPV-detect negative at 3 months after primary RT/CRT 3. Repeated measures of plasma HPV DNA levels up to a period of 12 months post RT/CRT (timepoints defined in the Interventions field) will be associated with the clinical and radiological response 4. Sensitivity and specificity of HPV-detect in measuring plasma HPV DNA levels compared with HPV DNA levels from diagnostic tissue at baseline; defined as the proportions of true positives and the proportions of true negatives, respectively 5. The pattern of plasma HPV DNA responses to RT/CRT presented by calculating the percentage change in HPV DNA level at each assessment timepoints from baseline (timepoints defined in the Interventions field)	—

Measure

Time frame

1. The sensitivity of HPV-detect (using plasma HPV DNA levels) in correctly identifying those with residual disease at 3 months following completion of primary RT/CRT; defined as the proportion of patients who are HPV-detect positive among those with residual disease according to 18F-FDG PET-CT at the same timepoint 2. The proportion of patients who have no residual disease on biopsy/neck dissection amongst those with residual disease according to 18F FDG PET-CT but HPV-detect negative at 3 months after primary RT/CRT 3. Repeated measures of plasma HPV DNA levels up to a period of 12 months post RT/CRT (timepoints defined in the Interventions field) will be associated with the clinical and radiological response 4. Sensitivity and specificity of HPV-detect in measuring plasma HPV DNA levels compared with HPV DNA levels from diagnostic tissue at baseline; defined as the proportions of true positives and the proportions of true negatives, respectively 5. The pattern of plasma HPV DNA responses to RT/CRT presented by calculating the percentage change in HPV DNA level at each assessment timepoints from baseline (timepoints defined in the Interventions field)

—

Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026