Head and Neck Cancer
Conditions
Brief summary
This is a clinical, observational, non-pharmacological, multicenter, prospective case-control no-profit study to assess the prognostic role of several circulating inflammatory biomarkers
Interventions
OTHERblood sampling
blood sampling at baseline, 1,3,6 months after surgery and eventually when recurrence is detected. If adjuvant treatment is planned, blood sampling at baseline, 1 month after surgery, 1,3,6 months after the last fraction of RT and eventually when recurrence is detected.
Sponsors
Ospedale Policlinico San Martino
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age > 18 years; 2. Written informed consent; 3. Squamous carcinoma of the hypopharynx, larynx and oral cavity; 4. Clinical stage I-IVa according to the VIII edition of AJCC staging system 5. Primary surgery as first line curative intent treatment, followed by ± adjuvant radiotherapy± chemotherapy based on the pathological findings following the NCCN guidelines
Exclusion criteria
1. Relapsing or metastatic disease 2. Locally advanced disease not amenable to curative intent treatment 3. Previous local or systemic treatment for head and neck cancer 4. Previous malignancies (exluding non-melanoma skin cancers) unless complete remission has been achieved at least 5 years before entering the study 5. Psychiatric disorder or known substance abuse 6. Concomitant immunosuppressive treatment 7. Concomitant immunostimulant treatment 8. Chronic inflammatory disease 9. Autoimmune disease 10. Major surgery in the previous year 11. History of recent onset of any condition which, in the investigator's opinion, could interfere with patient adherence for the entire duration of the protocol. 12. Positive serum pregnancy test for women of childbearing age. Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To identify a profile of circulating biomarkers in patients affected by HNSCC | 72 months |
| To identify a subset of patients in which biomarkers modifications might anticipate disease recurrence | 72 months |
Countries
Italy
Outcome results
None listed