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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06094985
Enrollment
20
Registered
2023-10-23
Start date
2014-02-12
Completion date
2026-05-31
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

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.

Interventions

GENETICDNA 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.

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence2 yearsRecurrent disease within 2 years after surgery. Is presence of these DNA changes in blood correlated to recurrence?
Survival2 yearsAlive/dead. Is presence of these DNA changes in blood correlated to survival?
Treatment response6 monthsIs presence of these DNA changes in blood correlated to treatment response?

Secondary

MeasureTime frameDescription
Pathological parameters6 monthsIs presence of these DNA changes correlated to pathological parameters (LVI, Pn, WPOI and margins).
Radiological parameters9 monthsIs presence of these DNA markers in blood correlated to PET-findings?
Stage2 yearsIf patients are stratified by stage, are there any differences in Outcome 1-5 (please see above)

Countries

Sweden

Contacts

Primary ContactAnders Näsman, MD PhD
anders.nasman@ki.se+46812370000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026