NCT04567082

Brief Summary

This clinical study aims to evaluate proteome- and methylation profiles in saliva in patients with oropharyngeal cancers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

September 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

May 2, 2024

Status Verified

May 1, 2024

Enrollment Period

3.4 years

First QC Date

September 23, 2020

Last Update Submit

May 1, 2024

Conditions

Oropharynx Cancer

Outcome Measures

Primary Outcomes (1)

  • Differences in proteome and methylation profiles

    Differences between cancer- and control group

    At diagnosis

Study Arms (2)

Cancer group

Diagnostic Test: Examination of saliva

Control group

Diagnostic Test: Examination of saliva

Interventions

Examination of salivaDIAGNOSTIC_TEST

Collection of saliva samples

Cancer groupControl group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Written informed consent
  • Verified oropharyngeal squamous cell carcinoma

You may not qualify if:

  • Other active cancer
  • Uncontrolled comorbidity
  • Unable to give informed consent
  • Control group:
  • Written informed consent
  • Normal ENT examination
  • Active cancer
  • Uncontrolled comorbidity
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otolaryngology - Head and Neck Surgery

Aalborg, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Michael Gaihede, Professor

    Department of Otolaryngology - Head and Neck Surgery, Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, M.D.

Study Record Dates

First Submitted

September 23, 2020

First Posted

September 28, 2020

Study Start

September 25, 2020

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

May 2, 2024

Record last verified: 2024-05

Locations

DK(1)