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

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06094985
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 30.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Genetic: DNA exome sequencing of tumor and blood

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prognostic Markers for a Better Follow-up in Head and Neck Cancer.
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: May 31, 2024
• Anticipated Study Completion Date: May 31, 2026

Arms and Interventions

Arm

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.

Outcome Measures

Primary Outcome Measures

1. Recurrence [2 years]

   Recurrent disease within 2 years after surgery. Is presence of these DNA changes in blood correlated to recurrence?

2. Survival [2 years]

   Alive/dead. Is presence of these DNA changes in blood correlated to survival?

3. Treatment response [6 months]

   Is presence of these DNA changes in blood correlated to treatment response?

Secondary Outcome Measures

1. Pathological parameters [6 months]

   Is presence of these DNA changes correlated to pathological parameters (LVI, Pn, WPOI and margins).

2. Radiological parameters [9 months]

   Is presence of these DNA markers in blood correlated to PET-findings?

3. Stage [2 years]

   If patients are stratified by stage, are there any differences in Outcome 1-5 (please see above)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska universitetssjukhuset	Stockholm		Sweden	17176

Sponsors and Collaborators

• Karolinska Institutet

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anders Näsman, Assoc Prof, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT06094985
• Other Study ID Numbers: 2023-04222-01
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 23, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

No Results Posted as of Oct 23, 2023