ctDNA Liquid Biopsy for Early Assessment of Residual Disease in HPV-associated Head and Neck Cancer (Clear-HPVca)

NCT06730412 | Completed

• 2 other identifiers: 18-653R03DE030550
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test a new liquid biopsy assay for detecting residual disease after surgery in patients with HPV-associated head and neck cancer.

Conditions

HPV Positive Oropharyngeal Squamous Cell Carcinoma

Keywords

MRD; HPV; HPV+ HNSCC; NGS; HPV-DeepSeek; squamous cell carcinoma; head and neck squamous cell carcinoma; circulating tumor DNA; liquid biopsy; minimal residual disease

Outcome Measures

Primary Outcomes (2)

• Disease free survival

  Disease free survival in patients with versus without minimal residual disease detection after surgery

  2 years

• Overall survival

  Overall survival in patients with versus without minimal residual disease detection after surgery

  2 years

Secondary Outcomes (2)

• Disease free survival

  2 years

• Overall survival

  2 years

Study Arms (1)

HPV-associated head and neck cancer patients treated with surgery

AJCC 8 Stage I-III HPV+ head and neck cancer patients treated with curative intent surgery

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

AJCC 8 Stage I-III HPV+ Head and Neck Cancer patient undergoing curative intent surgical resection

You may qualify if:

• Greater than or equal to 18 years of age
• Newly diagnosed, untreated, histologically confirmed HPV-associated head and neck cancer
• Scheduled for curative intent resection as primary treatment
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

You may not qualify if:

• Pregnant
• Receiving treatment for concurrent second malignancy

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator
• National Institutes of Health (NIH): collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

Department of Otolaryngology - Head and Neck Surgery, Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, and tumor tissue

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Neoplasms by Site; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Harvard Medical School

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: August 1, 2020
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: December 4, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)