NCT06215612

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
45mo left

Started Feb 2024

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Feb 2024Feb 2030

First Submitted

Initial submission to the registry

December 29, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2030

Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

December 29, 2023

Last Update Submit

January 10, 2024

Conditions

Head and Neck NeoplasmsCarcinoma, Squamous

Outcome Measures

Primary Outcomes (1)

  • percentage of patients with 50% decrease in ctDNA

    7 weeks after start of radiotherapy

Secondary Outcomes (2)

  • 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

Interventions

Blood draw, MRIOTHER

Blood draw, MRI

Eligibility Criteria

Age19 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Palliative therapy intent
  • Not MR eligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck NeoplasmsCarcinoma, Squamous Cell

Interventions

Blood Specimen CollectionMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesSpectrum AnalysisChemistry Techniques, Analytical

Central Study Contacts

Franziska Eckert, M.D.

CONTACT

+43-1-40400-26920franziska.eckert@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Head of Department

Study Record Dates

First Submitted

December 29, 2023

First Posted

January 22, 2024

Study Start

February 1, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2030

Last Updated

January 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share