Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-19

Study Completion Date

2033-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary goal of this study is to examine whether recurrence of HPV-associated OPSCC can be predicted by two factors: 1) mutations in genes called TRAF3 and CYLD, and 2) measurements of circulating HPV DNA in blood plasma. The study will also investigate whether HPV integration is associated with TRAF3 and CYLD mutations, and whether recurrence prediction improves when looking at HPV integration along with TRAF3 and CYLD mutations.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HPV Serum DNA Levels Predicting Outcome in p16+ Squamous Cell Head and Neck Cancer

NCT01984359

Subjects With p16 Positive/HPV Positive Squamous Cell Carcinomas of the Oropharynx

COMPLETED NA

New Prognostic and Predictive Biomarkers for HPV-associated Oropharyngeal Cancer

NCT06097936

PREDICTIVE BIOMARKERS Evaluation of HPV-specific E5 Transcript Expression in a Cohort of Patients With HPV-associated OPC HPV 16 Positive Oropharyngeal Tumors (OPC)

UNKNOWN

Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer

NCT04574635

Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Infiltrating Cervical Carcinoma +24 more

ACTIVE_NOT_RECRUITING

Blood and Urine HPVDNA as Minimally Invasive Biomarkers for Cervical Cancer Detection and Surveillance Following Treatment

NCT04743674

Cervical Cancer

RECRUITING

Assessment of Prognosis Using Peripheral Blood Circulating Tumor DNA in Patients With Cervical Cancer

NCT05602831

Locally Advanced Cervical Cancer

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oropharyngeal Squamous Cell Carcinoma Carcinoma, Squamous Cell Head and Neck Squamous Cell Carcinoma Oropharynx Squamous Cell Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HPV+ OPSCC Patients

Patients with p16+ squamous cell carcinoma of the oropharynx (or unknown primary) who will receive definitive cancer treatment.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ≥ 18 years of age
* T0-T2 N2a-N3 M0 or T3-T4 N0-N3 M0 (AJCC 7th edition)
* Biopsy proven squamous cell carcinoma of the oropharynx or unknown primary
* No prior therapy
* No evidence of distant metastatic disease
* p16 positive = diffuse ≥ 70% tumor cell expression, with at least moderate (2/3+) staining intensity
* Planned for receipt of definitive cancer treatment
* ECOG Performance Status 0-1
* Patients must be deemed able to comply with the treatment plan and follow-up schedule.
* Patients must provide study specific informed consent prior to study entry

Exclusion Criteria

* Prior history of radiation therapy to the head and neck
* Prior history of head and neck cancer.
* Inadequate pre-treatment tissue sample for tumor genomic analyses

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No