Oropharyngeal CancerOROPAPNCT04189003
Molecular Signatures of HPV+ ORL Cancers (OROPAP)
An observational study of Oropharyngeal Cancer and Human Papillomavirus-Related Carcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this study is to identify HPV molecular signature in head and neck cancer to establish a new classification for positive human papillomavirus oropharyngeal tumor Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Cancer, Human Papillomavirus-Related Carcinoma
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2019to 30 Nov 2020
- 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 HPV-induced oropharyngeal cancer with survival follow-up greater than 2 years
Who may be able to join
- Patients with HPV + oropharyngeal cancer
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Européen Georges Pompidou
Paris, Île-de-France Region, 75015
About this study
Official title: Identification of Specific Molecular Signatures by Capture-HPV and Next-generation Sequencing in HPV-induced Oropharyngeal Cancers
The aim of this study is to identify HPV molecular signature in head and neck cancer to establish a new classification for positive human papillomavirus oropharyngeal tumor
Read the detailed description
OROPAP is a monocentric exploratory study with retrospective inclusion of patients.
The retrospective study focus on patients who have had surgery for HPV-positive oropharyngeal tumors whose survival is at least 2 year.
Frozen and or FFPE biopsies of these tumors and frozen blood samples are available via the HEGP biological resources platform.
The HPV molecular signatures will be identified by the capture-HPV technique.
For each patient, clinical-anatomo-pathological data such as tumor size, tumor stage, presence or absence of metastasis, histological stage, different treatment lines and 2-years survival data will be collected through the use of data warehouse available on the HEGP.
- Keywords
- ORL Cancers, HPV+ tumor, molecular signature, human papillomavirus
- Medical subject headings
- Oropharyngeal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Description the HPV molecular signatures identified by the Capture-HPV technique and comparison of these signatures with those already described in the classification described in the Holmes et al. in the cervix
Establish a new classification based on HPV molecular signature for positive human papillomavirus oropharyngeal tumor
Measured: 18 months
Secondary outcomes (6)
Quantification of HPV circulating tumoral DNA in peripheral blood by droplet based digital PCR
Find in the peripheral blood of patients, the presence of circulating tumoral HPV DNA (ctDNA) by droplet based digital PCR and when it is possible compare chromosomal insertion patterns of HPV ct DNA as those found in tumors
Measured: 18 months
Correlate identified HPV molecular signature with clinical-anatomo-pathological data.
Look for an association between the presence of specific HPV molecular signatures and clinical-anatomo-pathological data.
Measured: 18 months
Number of Death of any cause, or eventual relapse
Look for an association between the presence of these molecular signatures and the survival of patients.
Measured: 18 months
Ratio of the number of copies of viral genes to the number of cells
Measure the viral load of HPV in the tumor.
Measured: 18 months
Precise description of HPV insertion localisation in human genome when HPV is integrated
Identify disrupted metabolic pathways in tumor cells.
Measured: 18 months
Description of new HPV viral variants based on complete HPV genome sequencec obtained by Capture-HPV coupled with NGS
Analyze of complete viral genomes and identify potential variants through sequencing data analysis
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start1 Jun 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal CancerStudies 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
- Retrospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène PÉRÉ, PhD, Study director, AP-HP, Hôpital Européen Georges Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189003
- Sponsor's protocol ID
- APHP180166
- Other IDs
- APHP180166
- Acronym
- OROPAP
- Status last verified
- Sep 2021
- First submitted
- 18 Oct 2019
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in publication could be shared. Individual participant data detailed in meta analysis protocol could be shared
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Specific Molecular Signatures by Capture-HPV and Next-generation Sequencing in HPV-induced Oropharyngeal Cancers
- ClinicalTrials.gov ID
- NCT04189003
- Acronym / sponsor ID
- OROPAP / APHP180166
- Keywords
- ORL Cancers, HPV+ tumor, molecular signature, human papillomavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 6 Dec 2019 (actual)
- 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 aim of this study is to identify HPV molecular signature in head and neck cancer to establish a new classification for positive human papillomavirus oropharyngeal tumor
Detailed description
OROPAP is a monocentric exploratory study with retrospective inclusion of patients.
The retrospective study focus on patients who have had surgery for HPV-positive oropharyngeal tumors whose survival is at least 2 year.
Frozen and or FFPE biopsies of these tumors and frozen blood samples are available via the HEGP biological resources platform.
The HPV molecular signatures will be identified by the capture-HPV technique.
For each patient, clinical-anatomo-pathological data such as tumor size, tumor stage, presence or absence of metastasis, histological stage, different treatment lines and 2-years survival data will be collected through the use of data warehouse available on the HEGP.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HPV-induced oropharyngeal cancer with survival follow-up greater than 2 years
Key inclusion criteria (1 listed)
- Patients with HPV + oropharyngeal cancer
Key exclusion criteria (1 listed)
- NA
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
Description the HPV molecular signatures identified by the Capture-HPV technique and comparison of these signatures with those already described in the classification described in the Holmes et al. in the cervix
Time frame: 18 months
Establish a new classification based on HPV molecular signature for positive human papillomavirus oropharyngeal tumor
6 secondary outcomes
Quantification of HPV circulating tumoral DNA in peripheral blood by droplet based digital PCR
Time frame: 18 months
Correlate identified HPV molecular signature with clinical-anatomo-pathological data.
Time frame: 18 months
Number of Death of any cause, or eventual relapse
Time frame: 18 months
Ratio of the number of copies of viral genes to the number of cells
Time frame: 18 months
Precise description of HPV insertion localisation in human genome when HPV is integrated
Time frame: 18 months
Description of new HPV viral variants based on complete HPV genome sequencec obtained by Capture-HPV coupled with NGS
Time frame: 18 months
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 4 Oct 2021.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in publication could be shared. Individual participant data detailed in meta analysis protocol could be shared
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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.
Hélène PÉRÉ, PhD study director
AP-HP, Hôpital Européen Georges Pompidou
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 Cancer and Human Papillomavirus-Related Carcinoma, 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 1 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 4 Oct 2021. 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?
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?
Description the HPV molecular signatures identified by the Capture-HPV technique and comparison of these signatures with those already described in the classification described in the Holmes et al. in the cervix (time frame: 18 months). 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 Oct 2021.