Specific Methylation Profiles in HNSCC | NCT04567056

Studies
Specific Methylation Profiles in HNSCC

NCT04567056

Sponsor

Aalborg University Hospital

Status

Recruiting

Last Update Posted

Feb 7, 2025Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

Blood sample

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

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 16, 2020Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Jun 1, 2026Estimated

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

Feb 5, 2025

Last Update Posted Date

Feb 7, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In the study, N-20190047, the investigators aim to define specific methylation patterns in a group of patients with head and neck squamous cell carcinomas.

With this study the investigators aim to validate these findings in a larger cohort.

Detailed Description

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

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cancer group		Patients with verified head and neck squamous cell carcinomas	Diagnostic Test: Blood sample
Control group		Matched control group without active or earlier cancer and a normal ENT examination.	Diagnostic Test: Blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sample	Diagnostic Test	A separate blood sample will be taken for methylation-analyses	Cancer group Control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic accuracy	How accurate can the methylation profiles diagnose the head and neck squamous cell carcinoma	At diagnosis

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Cancer group:

Inclusion Criteria:

Written informed consent
Verified head and neck 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:

Other 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

Cancer group:

Patients referred from the region of Northern Denmark to the Department of Otorhinolaryngology - Head and Neck Surgery with suspicion of, or with already verified Head and neck squamous cell carcinoma. Only patients with verified squamous cell carcinoma after diagnostic work-up will be eligible.

Control group:

Patients referred from the region of Northern Denmark to the Department of Otorhinolaryngology - Head and Neck Surgery for evaluation or treatment, but without suspected or verified malignancy of the head and neck.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christian Danstrup, M.D.	Contact	+45 23800598		csd@rn.dk
Michael Gaihede, Professor	Contact

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	Recruiting	Aalborg		9000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D000077195	Squamous Cell Carcinoma of Head and Neck
D006258	Head and Neck Neoplasms
D002294	Carcinoma, Squamous Cell

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided