NCT02045186

Brief Summary

The purpose of this research study is to determine whether and when patients with human papilloma virus positive squamous cell cancer of the oropharynx treated with radiation and chemotherapy clear their human papilloma virus infection.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

January 22, 2014

Last Update Submit

May 1, 2017

Conditions

Carcinoma, Squamous CellHead and Neck NeoplasmsOropharyngeal Neoplasms

Keywords

Human Papilloma VirusOropharynxOropharyngeal Squamous Cell CarcinomaSquamous Cell CarcinomaRadiation TherapyChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with HPV-positive OPSCC undergoing CRT who are clear of their oral HPV infection at each time-point

    2 years post-CRT of last enrolled patient

Secondary Outcomes (3)

  • Time to HPV clearance for patients with HPV-positive OPSCC undergoing CRT

    2 years post-CRT of last enrolled patient

  • Number of aneuploidy cells as measured by FISH (Florescent in-situ hybridization) and the mRNA copy number for HPV E6 and HPV E7 at each time-point

    2 years post-CRT of last enrolled patient

  • Clinical outcomes of interest (local control, loco-regional control, distant metastasis-free survival, and overall survival (OS)) in patients with HPV-positive OPSCC undergoing CRT

    2 years post-CRT of last enrolled patient

Study Arms (1)

Assessment of Oral HPV Infection

OTHER

Oral HPV infection will be assessed 14 times, once prior to starting CRT, weekly during CRT, and then serially post-treatment: 4-8 weeks, 3 months, 6 months, 12 months, 18 months, 24 months. Patients will provide samples of their saliva and exfoliated epithelial cells at these timepoints. Samples will be collected with supplies provided by and analyzed by OralDNA Labs.

Other: Assessment of Oral HPV Infection

Interventions

Assessment of Oral HPV InfectionOTHER

Saliva and exfoliated oral epithelial cells will be collected with collection supplies provided by OralDNA Labs. Patients will swish and gargle a saline solution for 30 seconds and expectorate it into a funneled collection tube. The collected specimen will be sent to OralDNA Labs. Three diagnostic tests will be performed on each sample to assess oral HPV infection: 1. Polymerase chain reaction (PCR) for HPV DNA. 2. Fluorescent in-situ hybridization (FISH). 3. Viral expression: The test is based on the measurement of the viral RNA levels by methods of detection of the fluorochrome labeled HPV probes by flow cytometry.

Assessment of Oral HPV Infection

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years of age (no upper age limit)
  • AnyT, AnyN, M0 squamous cell carcinoma of the oropharynx
  • Biopsy proven squamous cell carcinoma that is HPV positive via standard pathological assessment of tumor tissues in pathology department at the treating institution
  • Scheduled for definitive CRT as primary treatment of their oropharynx cancer

You may not qualify if:

  • Prior history of radiation therapy to the head and neck
  • Prior history of mucosal head and neck cancer.
  • Not willing or able to comply with study specific procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Carcinoma, Squamous CellHead and Neck NeoplasmsOropharyngeal NeoplasmsSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellNeoplasms by SitePharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Bhishamjit Chera, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 24, 2014

Study Start

December 1, 2013

Primary Completion

March 1, 2014

Study Completion

November 1, 2014

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations

US(1)