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NCT05373251Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 13 May 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
500 (estimated)
First submitted
3 May 2022
Start date
Aug 2022
Primary completion date
Aug 2027
Lead sponsor
British Columbia Cancer Agency
NCT number
NCT05373251

What you commit to

  • Study type: Interventional
  • Planned participants: 500
  • From Aug 2022 to the primary completion date, Aug 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • • 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

Who the study is looking for

  • 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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.