Epigenetic Changes in Head and Neck Cancer | NCT04260074

Studies
Epigenetic Changes in Head and Neck Cancer

NCT04260074

Sponsor

Aalborg University Hospital

Status

Completed

Last Update Posted

Jul 21, 2021Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Head and Neck Cancer
Squamous Cell Carcinoma
Head and Neck Squamous Cell Carcinoma
Head and Neck Neoplasms

Interventions

Not provided

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

Jul 2021

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

Mar 11, 2020Actual

Primary Completion Date

Jul 14, 2021Actual

Completion Date

Jul 14, 2021Actual

First Submitted Date

Feb 5, 2020

First Submission Date that Met QC Criteria

Feb 6, 2020

First Posted Date

Feb 7, 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

Jul 20, 2021

Last Update Posted Date

Jul 21, 2021Actual

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

Description Module

Brief Summary

With this study, the investigators will investigate the epigenetic changes, which may contribute to the development of head and neck squamous cell carcinomas.

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oral Cancer group		20 consecutive patients with oral squamous cell carcinoma referred to the Department of Otolaryngology - Head and Neck Surgery
Healthy oral mucosa group		20 controls with normal buccal mucosa upon examination.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Differences in epigenetic changes	Differences between tumor- and healthy group	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Cancer group:

Inclusion Criteria :

Written informed consent
Histologically confirmed oral squamous cell carcinoma

Exclusion Criteria:

History of cancer
Uncontrolled comorbidity

Control group:

Inclusion Criteria :

Written informed consent
Normal buccal mucosal surface.
Normal ENT-examination

Exclusion Criteria:

History of cancer
Uncontrolled comorbidity

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 referred to The Department of Otolaryngology - Head and Neck surgery

Controlgroup:

Patients referred to a private clinic for oral and maxillofacial surgery

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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Otolaryngology - Head and Neck Surgery		Aalborg		9000	Denmark

Condition Browse Module

MeSH Terms

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

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial

Browse Leaves

Not provided

Browse Branches

Not provided