Oropharyngeal NeoplasmsPapillopharNCT00918710
Human Papillomavirus and Oropharynx Carcinoma
An observational study of Oropharyngeal Neoplasms, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
High risk papillomavirus (HR-HPV) have an oncogenic role in Oropharyngeal squamous cell carcinomas (OP-SCC) in at least 25% of the cases and the prevalence is increasing. HPV+ might be more chemo and radio sensible with a better prognosis (disease-free survival (DFS) and overall survival (OS) as compared to HPV… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Neoplasms
- How many people
- 362 participants
- Where
- 1 siteFrance
- Study dates
- May 2009to May 2017
- 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: Patients with squamous cell carcinoma of oropharynx followed by the participating centers
Who may be able to join
- Squamous cell carcinoma of Oropharynx proven histologically
- All stages TNM
- informed consent
- No previous or simultaneous Head Neck cancer
- Age >18
Who cannot join
- Squamous cell carcinoma other than oropharynx
- 2nd synchronous SCC localization
- No consent
- age < 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Human Papillomavirus (HPV) Status in Carcinologic Prognosis of Oropharynx Squamous Cell Carcinoma.
High risk papillomavirus (HR-HPV) have an oncogenic role in Oropharyngeal squamous cell carcinomas (OP-SCC) in at least 25% of the cases and the prevalence is increasing. HPV+ might be more chemo and radio sensible with a better prognosis (disease-free survival (DFS) and overall survival (OS) as compared to HPV negative OP-SCC ; hypothesis : 2y DFS > 20% improvement). The principal objective is to determine the impact of the status of HR-HPV in the prognosis of the OP-SCC. The principal criteria is the 2-years DFS.
Secondary objective : virologic characteristics of HPV+ tumors.
Read the detailed description
The study has no impact on the treatment of the observed population. The clinical study include TNM status, previous story of HPV infection, smoking and alcoholic habits, treatment and outcome during 5 years. The virologic study include : HPV type, E6-E7 viral charge of HPV16, viral DNA integration in the tumoral genome, HPV16 variants, expression of HPV 16, 18, 31, 45 coding oncoproteins E6-E7 mRNA. Moreover a serologic study will be done.
- Conditions
- Oropharyngeal Neoplasms
- Keywords
- Squamous cell carcinoma of Oropharynx, Human papillomavirus., Biological prognostic markers.
- Medical subject headings
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with oropharyngeal squamous cell carcinomas |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS at 2 years in HPV + and - tumors
Measured: at 2 years
Secondary outcomes (3)
Overall survival
Measured: At 2 years
HPV status
Measured: At the inclusion
Overall survival
Measured: At 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2014
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oropharyngeal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean LACAU, PhD, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918710
- Sponsor's protocol ID
- AOM 08104
- Acronym
- Papillophar
- Status last verified
- Mar 2017
- First submitted
- 9 Jun 2009
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Pretet JL, Dalstein V, Touze A, Beby-Defaux A, Soussan P, Jacquin E, Birembaut P, Clavel C, Mougin C, Rousseau A, Lacau Saint Guily J; Papillophar Study Group. High levels of HPV16-L1 antibody but not HPV16 DNA load or integration predict oropharyngeal patient outcome: The Papillophar study. Clin Exp Med. 2023 Feb;23(1):87-96. doi: 10.1007/s10238-022-00796-2. Epub 2022 Feb 23.
PubMed 35199231
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Human Papillomavirus (HPV) Status in Carcinologic Prognosis of Oropharynx Squamous Cell Carcinoma.
- ClinicalTrials.gov ID
- NCT00918710
- Acronym / sponsor ID
- Papillophar / AOM 08104
- Conditions
- Oropharyngeal Neoplasms
- Keywords
- Squamous cell carcinoma of Oropharynx, Human papillomavirus., Biological prognostic markers.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2009 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2017 (estimated)
- First posted
- 11 Jun 2009 (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.
High risk papillomavirus (HR-HPV) have an oncogenic role in Oropharyngeal squamous cell carcinomas (OP-SCC) in at least 25% of the cases and the prevalence is increasing. HPV+ might be more chemo and radio sensible with a better prognosis (disease-free survival (DFS) and overall survival (OS) as compared to HPV negative OP-SCC ; hypothesis : 2y DFS > 20% improvement). The principal objective is to determine the impact of the status of HR-HPV in the prognosis of the OP-SCC. The principal criteria is the 2-years DFS.
Secondary objective : virologic characteristics of HPV+ tumors.
Detailed description
The study has no impact on the treatment of the observed population. The clinical study include TNM status, previous story of HPV infection, smoking and alcoholic habits, treatment and outcome during 5 years. The virologic study include : HPV type, E6-E7 viral charge of HPV16, viral DNA integration in the tumoral genome, HPV16 variants, expression of HPV 16, 18, 31, 45 coding oncoproteins E6-E7 mRNA. Moreover a serologic study will be done.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with oropharyngeal squamous cell carcinomas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with squamous cell carcinoma of oropharynx followed by the participating centers
Key inclusion criteria (5 listed)
- Squamous cell carcinoma of Oropharynx proven histologically
- All stages TNM
- informed consent
- No previous or simultaneous Head Neck cancer
- Age >18
Key exclusion criteria (4 listed)
- Squamous cell carcinoma other than oropharynx
- 2nd synchronous SCC localization
- No consent
- age < 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DFS at 2 years in HPV + and - tumors
Time frame: at 2 years
3 secondary outcomes
Overall survival
Time frame: At 2 years
HPV status
Time frame: At the inclusion
Overall survival
Time frame: At 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Derived from this study: PubMed 35199231Pretet JL, Dalstein V, Touze A, Beby-Defaux A, Soussan P, Jacquin E, Birembaut P, Clavel C, Mougin C, Rousseau A, Lacau Saint Guily J; Papillophar Study Group. High levels of HPV16-L1 antibody but not HPV16 DNA load or integration predict oropharyngeal patient outcome: The Papillophar study. Clin Exp Med. 2023 Feb;23(1):87-96. doi: 10.1007/s10238-022-00796-2. Epub 2022 Feb 23.
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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.
Jean LACAU, PhD, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Neoplasms, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Apr 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 France. 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?
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?
DFS at 2 years in HPV + and - tumors (time frame: at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00918710, which also lists 1 linked publication.
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 14 Apr 2017.