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NCT06094985 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06094985
Other study ID # 2023-04222-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 12, 2014
Est. completion date May 31, 2026

Study information
Verified date March 2024
Source Karolinska Institutet
Contact Anders Näsman, MD PhD
Phone +46812370000
Email anders.nasman@ki.se
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date May 31, 2026
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Genetic:
• DNA exome sequencing of tumor and blood
A piece from tumor and a blood sample will be collected during surgery. DNA will be extracted and presence of tumor specific mutations/aberrations will be analysed with a DNA exome seq panel. Presence of identified markers will be followed in blood samples with the same panel and these blood samples will be collected in routine follow-up during the first two years. Presence of markers over time in blood will be correlated to outcomes 1-5.

Locations
Country Name City State
Sweden Karolinska universitetssjukhuset Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence Recurrent disease within 2 years after surgery. Is presence of these DNA changes in blood correlated to recurrence? 2 years
Primary Survival Alive/dead. Is presence of these DNA changes in blood correlated to survival? 2 years
Primary Treatment response Is presence of these DNA changes in blood correlated to treatment response? 6 months
Secondary Pathological parameters Is presence of these DNA changes correlated to pathological parameters (LVI, Pn, WPOI and margins). 6 months
Secondary Radiological parameters Is presence of these DNA markers in blood correlated to PET-findings? 9 months
Secondary Stage If patients are stratified by stage, are there any differences in Outcome 1-5 (please see above) 2 years
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