ctDNA and MRI Parameters in Head and Neck Cancer | NCT06215612

Studies
ctDNA and MRI Parameters in Head and Neck Cancer

NCT06215612

Sponsor

Franziska Eckert

Status

Not yet recruiting

Last Update Posted

Jan 22, 2024Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Head and Neck Neoplasms
Carcinoma, Squamous

Interventions

Blood draw, MRI

Countries

Not provided

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

Jan 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2024Estimated

Primary Completion Date

Feb 2027Estimated

Completion Date

Feb 2030Estimated

First Submitted Date

Dec 29, 2023

First Submission Date that Met QC Criteria

Jan 10, 2024

First Posted Date

Jan 22, 2024Actual

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

Jan 10, 2024

Last Update Posted Date

Jan 22, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Patients undergoing primary radiochhemotherapy for locally advanced head and neck squamous cell carcinomas are included in this study. In addition to standard of care treatment patients will undergo addiational blood draws and MR imaging studies. Circulating cell free tumor DNA will be analysed in the blood samples. BIological data, imaging data and clinical data (such as patient and tumor characteristics, oncologic outcome, side effects) will be analysed in a biomathematical modelling approach.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
Blood draw, MRI	Other	Blood draw, MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage of patients with 50% decrease in ctDNA		7 weeks after start of radiotherapy

Secondary Outcomes

Measure	Description	Time Frame
Completion of all planned MR imagings and blood tests		through study completion, an average of 7 weeks
Decrease of tumor volume		7 weeks after start of radiotherapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Squamous cell carcinoma head and neck
Planned primary platinum based radiochemotherapy
ECOG 0-2

Exclusion Criteria:

Palliative therapy intent
Not MR eligible

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Franziska Eckert, M.D.	Contact	+43-1-40400-26920		franziska.eckert@meduniwien.ac.at

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

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

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

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection
D009682	Magnetic Resonance Spectroscopy

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