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

March 4, 2024 updated by: Anders Näsman, Karolinska Institutet
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Recruiting
        • Karolinska Universitetssjukhuset
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients diagnosed with a primary head and neck cancer Nov 2023 to May 2024 at Karolinska will be asked to participate.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient with head and neck cancer
Patient diagnosed with head and neck cancer
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Anders Näsman, MD PhD, Karolinska institutet and Karolinska Universitetssjukhuset

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2014

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-04222-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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