Oropharynx CancerPROMEONCT04567082
Proteome- and Methylation Profiles in Oropharyngeal Cancer
An observational study of Oropharynx Cancer, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
This clinical study aims to evaluate proteome- and methylation profiles in saliva in patients with oropharyngeal cancers Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oropharynx Cancer
- What is being tested?
- Examination of saliva
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Sep 2020to 31 Jan 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cancergroup: Patients from the Northern Region of Denmark referred to the Department of Otolaryngology - Head and Neck Surgery, Aalborg University Hospital with suspected or verified oropharyngeal cancer. Only patients with verified cancer after diagnostic work-up will be included in the analyses. Control group: Patients referred to the Department of Otolaryngology - Head and neck surgery, Aalborg University Hospital or a private clinic for Oral- and Maxillofacial surgery in Aalborg.
Who may be able to join
- Written informed consent
- Verified oropharyngeal squamous cell carcinoma
- Written informed consent
- Normal ENT examination
Who cannot join
- Other active cancer
- Uncontrolled comorbidity
- Unable to give informed consent
- Control group:
- Active cancer
- Uncontrolled comorbidity
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
This clinical study aims to evaluate proteome- and methylation profiles in saliva in patients with oropharyngeal cancers
- Conditions
- Oropharynx Cancer
- Being tested
- Examination of saliva
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination of salivaDiagnostic test
Collection of saliva samples
| Study group | Role | What they receive |
|---|---|---|
| Cancer group | Not described Receives: Diagnostic Test: Examination of saliva | |
| Control group | Not described Receives: Diagnostic Test: Examination of saliva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in proteome and methylation profiles
Differences between cancer- and control group
Measured: At diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start25 Sep 2020
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharynx CancerStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Sander Danstrup, Aalborg University Hospital
- Investigators
- Michael Gaihede, Professor, Principal investigator, Department of Otolaryngology - Head and Neck Surgery, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567082
- Sponsor's protocol ID
- N-20200024
- Acronym
- PROMEO
- Status last verified
- May 2024
- First submitted
- 23 Sep 2020
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteome- and Methylation Profiles in Oropharyngeal Cancer
- ClinicalTrials.gov ID
- NCT04567082
- Acronym / sponsor ID
- PROMEO / N-20200024
- Conditions
- Oropharynx Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 28 Sep 2020 (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.
This clinical study aims to evaluate proteome- and methylation profiles in saliva in patients with oropharyngeal cancers
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer group | – | Diagnostic Test: Examination of saliva |
| Control group | – | Diagnostic Test: Examination of saliva |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cancergroup: Patients from the Northern Region of Denmark referred to the Department of Otolaryngology - Head and Neck Surgery, Aalborg University Hospital with suspected or verified oropharyngeal cancer. Only patients with verified cancer after diagnostic work-up will be included in the analyses. Control group: Patients referred to the Department of Otolaryngology - Head and neck surgery, Aalborg University Hospital or a private clinic for Oral- and Maxillofacial surgery in Aalborg.
Key inclusion criteria (4 listed)
- Written informed consent
- Verified oropharyngeal squamous cell carcinoma
- Written informed consent
- Normal ENT examination
Key exclusion criteria (7 listed)
- Other active cancer
- Uncontrolled comorbidity
- Unable to give informed consent
- Active cancer
- Uncontrolled comorbidity
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 |
|---|---|---|
| Examination of salivaCollection of saliva samples | Diagnostic test | Cancer group, Control group |
Primary outcome
Differences in proteome and methylation profiles
Time frame: At diagnosis
Differences between cancer- and control group
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 2 May 2024.
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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.
Michael Gaihede, Professor principal investigator
Department of Otolaryngology - Head and Neck Surgery, Aalborg University Hospital
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 Oropharynx Cancer, run by Aalborg University Hospital at 1 site in Denmark.
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 7 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 2 May 2024. 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 Denmark. 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?
Differences in proteome and methylation profiles (time frame: At diagnosis). 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 2 May 2024.