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

NCT ID: NCT06094985

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-12

Study Completion Date

2026-05-31

Brief Summary

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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

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Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient with head and neck cancer

Patient diagnosed with head and neck cancer

DNA exome sequencing of tumor and blood

Intervention Type GENETIC

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.

Interventions

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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.

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Anders Näsman

Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anders Näsman, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska institutet and Karolinska Universitetssjukhuset

Locations

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Karolinska universitetssjukhuset

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Anders Näsman, MD PhD

Role: CONTACT

+46812370000

Facility Contacts

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Anders Näsman, MD PhD

Role: primary

+46812370000

Other Identifiers

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2023-04222-01

Identifier Type: -

Identifier Source: org_study_id

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