ctDNA and MRI Parameters in Head and Neck Cancer

January 10, 2024 updated by: Franziska Eckert

ctDNA and MR Imaging Parameters as Possible Biomarkers in Primary Radiochemotherapy of Head and Neck Squamous Cell Carcinomas

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Palliative therapy intent
  • Not MR eligible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Franziska Eckert

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2030

Study Registration Dates

First Submitted

December 29, 2023

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1452/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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