Identifying genetic markers to predict early relapse in throat cancer patients
A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse
This study is trying to find genetic clues that can help predict if throat cancer will come back early in patients who have just been diagnosed with advanced oropharyngeal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 267 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro di Riferimento Oncologico - Aviano Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Aviano and 4 other locations) |
| Trial ID | NCT06138483 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify new mutational and epigenetic signatures that can predict early relapse in patients with oropharyngeal squamous cell carcinoma (OPSCC). By analyzing the genetic and epigenetic changes in newly diagnosed, untreated stage III-IVa OPSCC patients, the study seeks to improve personalized treatment approaches. The findings will help in defining novel molecular markers for OPSCC and will set the groundwork for a multicenter prospective study to validate these markers. The study focuses on patients who have undergone definitive treatment and have a minimum follow-up of two years.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed, untreated patients with histologically confirmed stage III-IVa OPSCC who have undergone definitive treatment.
Not a fit: Patients with distant metastases at diagnosis or those managed with palliative intent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for OPSCC patients, potentially reducing the risk of early relapse.
How similar studies have performed: Other studies have shown promise in identifying genetic markers for cancer relapse, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * newly diagnosed, previously untreated, histologically confirmed stage III-IVa OPSCC, according to AJCC 7th Edition, * managed with definitive treatment modality (either radical surgery plus adjuvant radiotherapy ± chemotherapy or definitive chemo-radiotherapy) * minimum follow up of 2 years or who had disease recurrence within 2 years after the end of treatment. * neoplastic lesion contains ≥ 70% neoplastic cells Exclusion Criteria: Patients: * with distant metastases at diagnosis, * who have been managed with palliative intent; * with previous history of head and neck cancer are not eligible
Where this trial is running
Aviano and 4 other locations
- Centro di Riferimento Oncologico (CRO), IRCCS — Aviano, Italy (Recruiting)
- Ospedale San Martino di Belluno - ULSS 1 Dolomiti — Belluno, Italy (Recruiting)
- Ospedale dell'Angelo - Mestre - Ulss 3 Serenissima — Mestre, Italy (Recruiting)
- Ospedale Santa Maria degli Angeli - ASFO — Pordenone, Italy (Recruiting)
- Ospedale di Treviso - ULSS 2 Marca Trevigiana — Treviso, Italy (Recruiting)
Study contacts
- Principal investigator: Elisabetta Fratta, PhD — Centro di Riferimento Oncologico (CRO), IRCCS
- Study coordinator: Elisabetta Fratta, PhD
- Email: efratta@cro.it
- Phone: +390434659569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.