Squamous Cell Carcinoma of the OropharynxNCT01181648
Long-Term Impact of Human Papillomavirus (HPV) on Quality of Life
An observational study of Squamous Cell Carcinoma of the Oropharynx, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
Trial summary
The investigators are doing this study to learn about the quality of life patients have at the end of treatment. Some patients' cancers are related to human papilloma virus or HPV; others are not. HPV is a virus that can be sexually transmitted and is known to cause some types of cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Oropharynx
- What is being tested?
- questionnaire and semi-structured interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 210 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2010to Jun 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential research subjects will be identified through a Dataline query. While Dataline should capture most eligible patients, potential subjects can also be identified by a member of the Head and Neck DMT.
Who may be able to join
- 18 years of age or older
- Diagnosis of squamous cell carcinoma of the oropharynx confirmed by the pathology department at MSKCC
- Completed last treatment for oropharynx cancer (surgery, chemotherapy, or radiation) at least 12 months and no more than 5 years before the date of study enrollment
- Known tumor status or tumor available for HPV testing [based on chromogenic in situ hybridization with wide spectrum HPV probe (HPV III family 16 probe (Ventana) with affinity to HPV genotypes 16, 18, 31, 33, 35, 45, 51, 52, 56, 58, and 66) or p16 immunohistochemistry done in a Clinical Laboratory Improvement Amendment (CLIA)-approved laboratory; if either of these 2 tests are positive, the patient is classified as positive].
- Able to speak and read English (study questionnaire-Aim 1 and interview guide-Aim 2 are currently only available in English).
- Received at least one component of treatment for oropharynx cancer at MSKCC or the regional network sites
- If radiation therapy was part of treatment, it must have been delivered at MSKCC or the regional network sites
- For Aim 2 only, diagnosed with an HPV+ oropharynx cancer and have knowledge of this diagnosis prior to study enrollment
Who cannot join
- Diagnosed with recurrent disease following completion of primary curative treatment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering West Harrison
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York
Memoral Sloan Kettering Cancer Center at Phelps
Sleepy Hollow, New York, 10591
About this study
Official title: Surviving Oropharynx Cancer: Long-Term Impact of Human Papillomavirus (HPV) on Quality of Life
The investigators are doing this study to learn about the quality of life patients have at the end of treatment. Some patients' cancers are related to human papilloma virus or HPV; others are not. HPV is a virus that can be sexually transmitted and is known to cause some types of cancers. If your throat cancer was related to HPV, your doctor can discuss this with you in detail. The investigators want to see if there are differences in quality of life between patients whose cancers are caused by HPV and those who cancers are not caused by HPV. Throat cancers caused by HPV behave differently than throat cancers not caused by HPV. The investigators believe that patients with these two different types of throat cancer will also have different experiences after completing therapy. The investigators would like to understand what those differences are. The long-term goal of this study is to see what symptoms most patients have. The investigators can then try to treat them earlier, and hopefully, improve the symptoms. The investigators will also be able to plan more research to improve treatment for symptoms following treatment for cancer of the mouth and throat.
- Being tested
- questionnaire and semi-structured interviews
- Keywords
- Survivor, Human Papillomavirus (HPV), Quality of Life, Surviving Oropharynx Cancer, 10-111
- Medical subject headings
- 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.
questionnaire and semi-structured interviewsBehavioural
Survivors will be asked to complete a brief, self-administered, paper-based survey to assess quality of life, mental health and employment status following completion of therapy. Second, in a subset of 20 survivors of HPV+ oropharynx cancer, we will conduct in-depth, semi-structured, face-to-face interviews addressing the psychosocial impact of the HPV diagnosis. A follow up letter will be sent to participants who do not return their completed study questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| oropharynx cancer survivors | This study has two components. First, we will conduct a cross-sectional survey of 200 oropharynx cancer survivors, diagnosed with HPV+ tumors, who are at least 12 months from their last treatment. Second, in a subset of 20 survivors of HPV+ oropharynx cancer, we will conduct in-depth, semi-structured, face-to-face interviews addressing the psychosocial impact of the HPV diagnosis. Receives: Behavioral: questionnaire and semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess quality of life in survivors
of oropharynx cancer at least one year after completion of curative treatment in patients with HPV+ disease versus HPV- disease.
Measured: 2 years
Secondary outcomes (1)
Explore the psychosocial impact of a HPV diagnosis
on survivors of HPV+ oropharynx cancer
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the OropharynxStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shrujal Baxi, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181648
- Sponsor's protocol ID
- 10-111
- Status last verified
- Jun 2018
- First submitted
- 12 Aug 2010
- Last updated
- 20 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surviving Oropharynx Cancer: Long-Term Impact of Human Papillomavirus (HPV) on Quality of Life
- ClinicalTrials.gov ID
- NCT01181648
- Acronym / sponsor ID
- 10-111
- Keywords
- Survivor, Human Papillomavirus (HPV), Quality of Life, Surviving Oropharynx Cancer, 10-111
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 13 Aug 2010 (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 investigators are doing this study to learn about the quality of life patients have at the end of treatment. Some patients' cancers are related to human papilloma virus or HPV; others are not. HPV is a virus that can be sexually transmitted and is known to cause some types of cancers. If your throat cancer was related to HPV, your doctor can discuss this with you in detail. The investigators want to see if there are differences in quality of life between patients whose cancers are caused by HPV and those who cancers are not caused by HPV. Throat cancers caused by HPV behave differently than throat cancers not caused by HPV. The investigators believe that patients with these two different types of throat cancer will also have different experiences after completing therapy. The investigators would like to understand what those differences are. The long-term goal of this study is to see what symptoms most patients have. The investigators can then try to treat them earlier, and hopefully, improve the symptoms. The investigators will also be able to plan more research to improve treatment for symptoms following treatment for cancer of the mouth and throat.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oropharynx cancer survivors | – | Behavioral: questionnaire and semi-structured interviewsThis study has two components. First, we will conduct a cross-sectional survey of 200 oropharynx cancer survivors, diagnosed with HPV+ tumors, who are at least 12 months from their last treatment. Second, in a subset of 20 survivors of HPV+ oropharynx cancer, we will conduct in-depth, semi-structured, face-to-face interviews addressing the psychosocial impact of the HPV diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential research subjects will be identified through a Dataline query. While Dataline should capture most eligible patients, potential subjects can also be identified by a member of the Head and Neck DMT.
Key inclusion criteria (8 listed)
- 18 years of age or older
- Diagnosis of squamous cell carcinoma of the oropharynx confirmed by the pathology department at MSKCC
- Completed last treatment for oropharynx cancer (surgery, chemotherapy, or radiation) at least 12 months and no more than 5 years before the date of study enrollment
- Known tumor status or tumor available for HPV testing [based on chromogenic in situ hybridization with wide spectrum HPV probe (HPV III family 16 probe (Ventana) with affinity to HPV genotypes 16, 18, 31, 33, 35, 45, 51, 52, 56, 58, and 66) or p16 immunohistochemistry done in a Clinical Laboratory Improvement Amendment (CLIA)-approved laboratory; if either of these 2 tests are positive, the patient is classified as positive].
- Able to speak and read English (study questionnaire-Aim 1 and interview guide-Aim 2 are currently only available in English).
Key exclusion criteria (1 listed)
- Diagnosed with recurrent disease following completion of primary curative treatment
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 |
|---|---|---|
| questionnaire and semi-structured interviewsSurvivors will be asked to complete a brief, self-administered, paper-based survey to assess quality of life, mental health and employment status following completion of therapy. Second, in a subset of 20 survivors of HPV+ oropharynx cancer, we will conduct in-depth, semi-structured, face-to-face interviews addressing the psychosocial impact of the HPV diagnosis. A follow up letter will be sent to participants who do not return their completed study questionnaires. | Behavioural | oropharynx cancer survivors |
Primary outcome
To assess quality of life in survivors
Time frame: 2 years
of oropharynx cancer at least one year after completion of curative treatment in patients with HPV+ disease versus HPV- disease.
1 secondary outcome
Explore the psychosocial impact of a HPV diagnosis
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Shrujal Baxi, MD principal investigator
Memorial Sloan Kettering Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma of the Oropharynx, run by Memorial Sloan Kettering Cancer Center at 6 sites 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 8 inclusion and 1 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: finished, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess quality of life in survivors (time frame: 2 years). 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 20 Jun 2018.