Proteome- and Methylation Profiles in Oropharyngeal Cancer (PROMEO)

May 1, 2024 updated by: Christian Sander Danstrup, Aalborg University Hospital
This clinical study aims to evaluate proteome- and methylation profiles in saliva in patients with oropharyngeal cancers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Department of Otolaryngology - Head and Neck Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Cancer group:

Inclusion Criteria:

  • Written informed consent
  • Verified oropharyngeal squamous cell carcinoma

Exclusion Criteria:

  • Other active cancer
  • Uncontrolled comorbidity
  • Unable to give informed consent

Control group:

Inclusion Criteria:

  • Written informed consent
  • Normal ENT examination

Exclusion Criteria:

  • Active cancer
  • Uncontrolled comorbidity
  • Unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Diagnostic test: Examination of saliva
Collection of saliva samples
Cancer group
Diagnostic test: Examination of saliva
Collection of saliva samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in proteome and methylation profiles
Time Frame: At diagnosis
Differences between cancer- and control group
At diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Investigators

  • Principal Investigator: Michael Gaihede, Professor, Department of Otolaryngology - Head and Neck Surgery, Aalborg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2020

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (Actual)

September 28, 2020

Study Record Updates

Last Update Posted (Estimated)

May 2, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20200024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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