Carcinoma, Squamous CellNCT02045186
Monitoring of Oral Human Papillomavirus Infection (HPV) in HPV-positive Oropharyngeal Squamous Cell Carcinoma (OPSCC)
A study testing Assessment of Oral HPV Infection in people with Carcinoma, Squamous Cell and Head and Neck Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Carcinoma, Squamous Cell, Head and Neck Neoplasms, Oropharyngeal Neoplasms
- What is being tested?
- Assessment of Oral HPV Infection
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, 27599
About this study
Official title: Monitoring of Oral HPV Infection in HPV-positive Oropharyngeal Squamous Cell Carcinoma During and After Chemoradiotherapy (CRT)
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.
- Being tested
- Assessment of Oral HPV Infection
- Keywords
- Human Papilloma Virus, Oropharynx, Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma, Radiation Therapy, Chemotherapy
- Medical subject headings
- Carcinoma, Squamous Cell, Head and Neck Neoplasms, Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- Polymerase chain reaction (PCR) for HPV DNA.
- Fluorescent in-situ hybridization (FISH).
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Assessment of Oral HPV Infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with HPV-positive OPSCC undergoing CRT who are clear of their oral HPV infection at each time-point
Measured: 2 years post-CRT of last enrolled patient
Secondary outcomes (3)
Time to HPV clearance for patients with HPV-positive OPSCC undergoing CRT
Measured: 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
Measured: 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
Measured: 2 years post-CRT of last enrolled patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionMar 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous CellStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bhishamjit Chera, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045186
- Sponsor's protocol ID
- LCCC1338
- Status last verified
- May 2017
- First submitted
- 22 Jan 2014
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Oral HPV Infection in HPV-positive Oropharyngeal Squamous Cell Carcinoma During and After Chemoradiotherapy (CRT)
- ClinicalTrials.gov ID
- NCT02045186
- Acronym / sponsor ID
- LCCC1338
- Keywords
- Human Papilloma Virus, Oropharynx, Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma, Radiation Therapy, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment of Oral HPV Infection | Other | Other: Assessment of Oral HPV InfectionOral 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of Oral HPV InfectionSaliva 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. | Other | Assessment of Oral HPV Infection |
Primary outcome
Proportion of patients with HPV-positive OPSCC undergoing CRT who are clear of their oral HPV infection at each time-point
Time frame: 2 years post-CRT of last enrolled patient
3 secondary outcomes
Time to HPV clearance for patients with HPV-positive OPSCC undergoing CRT
Time frame: 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
Time frame: 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
Time frame: 2 years post-CRT of last enrolled patient
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bhishamjit Chera, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of Oral HPV Infection in people with Carcinoma, Squamous Cell and Head and Neck Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with HPV-positive OPSCC undergoing CRT who are clear of their oral HPV infection at each time-point (time frame: 2 years post-CRT of last enrolled patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.