Oropharyngeal CancerHPV OncoTect™NCT03604588
Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers
A study testing HPV OncoTect™ in people with Oropharyngeal Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
To determine the sensitivity of HPV OncotectTM to diagnose oropharyngeal cancers induced by oncogenic HPV Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Cancer
- What is being tested?
- HPV OncoTect™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2018to Jan 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Untreated oropharynx epidermoid carcinoma
- Patient ≥ 18 years old
- Patient affiliated to a social security scheme or beneficiary of such a scheme
- Information to the patient or his legal representative and signature of informed consent
Who cannot join
- Non-oropharyngeal epidermoid carcinoma
- Oropharyngeal epidermoid carcinoma previously treated
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Gustave Roussy
Villejuif, Val De Marne, 94805
Hatiham MIRGHANI, MD, 0142114211 ext. +33, haitham.mirghani@gustaveroussy.fr
About this study
To determine the sensitivity of HPV OncotectTM to diagnose oropharyngeal cancers induced by oncogenic HPV
- Conditions
- Oropharyngeal Cancer
- Being tested
- HPV OncoTect™
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV OncoTect™Diagnostic test
Salivary specimens will be collected from 40 patients with oropharyngeal cancer The saliva samples will be sent to incell dx, which will analyze them blindly (without knowledge of the clinicopathological information) with the HPV OncoTect ™ test.
Clinical and pathological information will be collected and maintained by the principal investigator At the end of the study, the results obtained with the HPV OncoTect ™ test will be confronted with the clinical and pathological results.
| Study group | Role | What they receive |
|---|---|---|
| Patients with oropharyngeal cancer | Other | Salivary specimens will be collected from 40 patients with oropharyngeal cancer The saliva samples will be sent to incell dx, which will analyze them blindly (without knowledge of the clinicopathological information) with the HPV OncoTect ™ test.
Clinical and pathological information will be collected and maintained by the principal investigator At the end of the study, the results obtained with the HPV OncoTect ™ test will be confronted with the clinical and pathological results. Receives: Diagnostic Test: HPV OncoTect™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity is defined as the probability that the oncotectTM HPV test is positive if the cancer is HPV-induced.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start17 Jan 2018
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
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 Gustave Roussy, Cancer Campus, Grand 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604588
- Sponsor's protocol ID
- 2016-A01655-46
- Other IDs
- 2016/2474
- Acronym
- HPV OncoTect™
- Status last verified
- Jul 2018
- First submitted
- 20 Jul 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers
- ClinicalTrials.gov ID
- NCT03604588
- Acronym / sponsor ID
- HPV OncoTect™ / 2016-A01655-46
- Conditions
- Oropharyngeal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 27 Jul 2018 (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.
To determine the sensitivity of HPV OncotectTM to diagnose oropharyngeal cancers induced by oncogenic HPV
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with oropharyngeal cancer | Other | Diagnostic Test: HPV OncoTect™Salivary specimens will be collected from 40 patients with oropharyngeal cancer The saliva samples will be sent to incell dx, which will analyze them blindly (without knowledge of the clinicopathological information) with the HPV OncoTect ™ test. Clinical and pathological information will be collected and maintained by the principal investigator At the end of the study, the results obtained with the HPV OncoTect ™ test will be confronted with the clinical and pathological results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Untreated oropharynx epidermoid carcinoma
- Patient ≥ 18 years old
- Patient affiliated to a social security scheme or beneficiary of such a scheme
- Information to the patient or his legal representative and signature of informed consent
Key exclusion criteria (2 listed)
- Non-oropharyngeal epidermoid carcinoma
- Oropharyngeal epidermoid carcinoma previously treated
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 |
|---|---|---|
| HPV OncoTect™Salivary specimens will be collected from 40 patients with oropharyngeal cancer The saliva samples will be sent to incell dx, which will analyze them blindly (without knowledge of the clinicopathological information) with the HPV OncoTect ™ test. Clinical and pathological information will be collected and maintained by the principal investigator At the end of the study, the results obtained with the HPV OncoTect ™ test will be confronted with the clinical and pathological results. | Diagnostic test | Patients with oropharyngeal cancer |
Primary outcome
Sensitivity is defined as the probability that the oncotectTM HPV test is positive if the cancer is HPV-induced.
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV OncoTect™ in people with Oropharyngeal Cancer, run by Gustave Roussy, Cancer Campus, Grand 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 4 inclusion and 2 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 27 Jul 2018. 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?
Contact Haitham MIRGHANI, MD (0142114211 ext. +33, haitham.mirghani@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity is defined as the probability that the oncotectTM HPV test is positive if the cancer is HPV-induced. (time frame: up to 12 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 27 Jul 2018.