blood 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.
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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.
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
IRCCS Policlinico San Martino
Genoa
Italy
More Ospedale Policlinico San Martino trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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