Clinical trial · Interventional
PATH Trial: Personalized Approaches in the Treatment of Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Whole genomic DNA/RNA tumour sequencing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Whole genomic DNA/RNA tumour sequencing
- description
- All participants will undergo pre-radiotherapy fresh core biopsies of the tumour. DNA libraries will be created and stored for future analysis.
- interventionNames
- Diagnostic Test: Whole genomic DNA/RNA tumour sequencing
Primary outcomes (1)
- measure
- Number of participants with local, regional and distant recurrence
- timeFrame
- 24 months post completion of radiotherapy
- description
- Proportion with recurrence
Secondary outcomes (4)
- measure
- Proportion who have sufficient biopsy possible to perform WGTA
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with locally advanced H\&N squamous cell carcinoma or nasopharyngeal cancer undergoing definitive radiation and/or chemoradiotherapy with curative intent at BC Cancer * Folowing subsites included: paranasal sinus, nasal cavity, nasopharynx, oral cavity, oropharynx, larynx, hypopharynx. * Patients willing to undergo study specific fresh biopsy of the tumour, and/or metastatic nodal site at baseline and at recurrence, and a blood test for genomic analysis. * ECOG PS 0-2 * Age \>/=18 years * Primary tumour or regional lymph nodes that are amenable to core biopsy and sufficient sampling for POG purposes * Measurable disease * Adequate organ function * Willingness to have their de-identified genomic and clinical data shared with national and international research collaborators and data sharing platforms (as detailed in the consent form) * Willingness to be contacted for future studies based on the data that is generate; included in this is the anticipation that patient would be fit or a candidate for clinical trials Exclusion Criteria: * • Primary skin, salivary gland and thyroid malignancies * Unwilling/unable to undergo biopsies and blood tests * Patients undergoing adjuvant radiotherapy after definitive surgery without gross residual disease * Patients with estimated life expectancy less than 12 months * Patients who have received prior chemoradiotherapy within the past 12 months
References
Publications (0)
Data not yet available