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Trial Title:
Prognostic Markers for a Better Follow-up in Head and Neck Cancer.
NCT ID:
NCT06094985
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Genetic
Intervention name:
DNA exome sequencing of tumor and blood
Description:
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.
Arm group label:
Patient with head and neck cancer
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.
Criteria for eligibility:
Study pop:
All patients diagnosed with a primary head and neck cancer Nov 2023 to May 2024 at
Karolinska will be asked to participate.
Sampling method:
Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Karolinska universitetssjukhuset
Address:
City:
Stockholm
Zip:
17176
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Anders Näsman, MD PhD
Phone:
+46812370000
Email:
anders.nasman@ki.se
Start date:
February 12, 2014
Completion date:
May 31, 2026
Lead sponsor:
Agency:
Karolinska Institutet
Agency class:
Other
Source:
Karolinska Institutet
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06094985