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PATH Trial: Personalized Approaches in the Treatment of Head and Neck Cancer

NCT05373251 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2022-05-13

No results posted yet for this study

Summary

1. To determine genomic markers of radioresistance by comparing patients with H\&N cancer who develop recurrence within twelve months of curative intent radiation and/or chemoradiotherapy to those without recurrence
2. To compare the genomic landscape of patients with and without EBV and HPV mediated H\&N cancer
3. To identify somatic mutations, gene expression changes or other potentially targetable abnormalities in patients with recurrent H\&N cancer that may provide information to guide systemic therapy in these patients

Conditions

Interventions

DIAGNOSTIC_TEST

Whole genomic DNA/RNA tumour sequencing

All participants will undergo pre-radiotherapy fresh core biopsies of the tumour. DNA libraries will be created and stored for future analysis. Participants with recurrence will have biopsy and subsequently will undergo rapid sequencing of RNA and DNA followed by bioinformatic analysis to identify somatic mutations or other abnormalities that might be "drivers" of an individual's cancer or predict response to therapies. These data will be compared to the literature and to a comprehensive database of drugs with the aim of identifying drugs most likely to target individual tumors based on the presence of mutated or abnormally expressed genes in the tumor. Any palliative systemic therapy treatment would be closely monitored for tolerability and response, as part of the general clinical care of someone on systemic therapy. The choice of systemic therapy will be up to the treating medical oncologist and the patient.

Sponsors & Collaborators

  • British Columbia Cancer Agency

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2027-08-31
Completion
2032-08-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05373251 on ClinicalTrials.gov