Prognostic Markers for a Better Follow-up in Head and Neck Cancer.

Recruiting

• Conditions: Head and Neck Cancer
• Interventions: Genetic: DNA exome sequencing of tumor and blood

• Registration Number: NCT06094985
• Lead Sponsor: Karolinska Institutet

Brief Summary

To identify tumor specific DNA mutations and aberrations and to follow these in blood over time to predict treatment response/survival and secondly to correlate presence of these markers in blood to pathological parameters (LVI, Pn, WPOI and margins), radiological findings and to tumor stage.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-12
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05
• Primary Completion: 2024-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patient diagnosed with head and neck cancer
• Treatment includes surgery
• Consent to participate

Exclusion Criteria

• No consent
• Age below 18 years
• No surgery
• No tumor material to sample

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with head and neck cancer	DNA exome sequencing of tumor and blood	Patient diagnosed with head and neck cancer

Primary Outcome Measures

Name	Time	Method
Recurrence	2 years	Recurrent disease within 2 years after surgery. Is presence of these DNA changes in blood correlated to recurrence?
Survival	2 years	Alive/dead. Is presence of these DNA changes in blood correlated to survival?
Treatment response	6 months	Is presence of these DNA changes in blood correlated to treatment response?

Secondary Outcome Measures

Name	Time	Method
Radiological parameters	9 months	Is presence of these DNA markers in blood correlated to PET-findings?
Pathological parameters	6 months	Is presence of these DNA changes correlated to pathological parameters (LVI, Pn, WPOI and margins).
Stage	2 years	If patients are stratified by stage, are there any differences in Outcome 1-5 (please see above)

Trial Locations

Locations (1)

Karolinska universitetssjukhuset; 🇸🇪 Stockholm, Sweden