Proteome- and Methylation Profiles in Oropharyngeal Cancer | NCT04567082

Studies
Proteome- and Methylation Profiles in Oropharyngeal Cancer

NCT04567082

Sponsor

Aalborg University Hospital

Status

Completed

Last Update Posted

May 2, 2024Actual

Enrollment

45Actual

Phase

Not provided

Conditions

Oropharynx Cancer

Interventions

Examination of saliva

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2020Actual

Primary Completion Date

Jan 31, 2024Actual

Completion Date

Jan 31, 2024Actual

First Submitted Date

Sep 23, 2020

First Submission Date that Met QC Criteria

Sep 23, 2020

First Posted Date

Sep 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2024

Last Update Posted Date

May 2, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cancer group			Diagnostic Test: Examination of saliva
Control group			Diagnostic Test: Examination of saliva

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Examination of saliva	Diagnostic Test	Collection of saliva samples	Cancer group Control group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Gaihede, Professor	Department of Otolaryngology - Head and Neck Surgery, Aalborg University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Otolaryngology - Head and Neck Surgery		Aalborg			Denmark

Condition Browse Module

MeSH Terms

ID	Term
D009959	Oropharyngeal Neoplasms

Ancestor Terms

ID	Term
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided