Enrolling by invitation NCT06809673
PA.RI.GE. Study. The Prognostic Role of Inflammatory Circulating Biomarkers in HNSCC: a Prospective Multicentric Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood sampling.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other 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.
Primary outcome measures
- To identify a profile of circulating biomarkers in patients affected by HNSCC [Time frame: 72 months]
- To identify a subset of patients in which biomarkers modifications might anticipate disease recurrence [Time frame: 72 months]
Eligibility criteria
Inclusion criteria
- Age \> 18 years;
- Written informed consent;
- Squamous carcinoma of the hypopharynx, larynx and oral cavity;
- Clinical stage I-IVa according to the VIII edition of AJCC staging system
- Primary surgery as first line curative intent treatment, followed by ± adjuvant radiotherapy± chemotherapy based on the pathological findings following the NCCN guidelines
Exclusion criteria
- Relapsing or metastatic disease
- Locally advanced disease not amenable to curative intent treatment
- Previous local or systemic treatment for head and neck cancer
- Previous malignancies (exluding non-melanoma skin cancers) unless complete remission has been achieved at least 5 years before entering the study
- Psychiatric disorder or known substance abuse
- Concomitant immunosuppressive treatment
- Concomitant immunostimulant treatment
- Chronic inflammatory disease
- Autoimmune disease
- Major surgery in the previous year
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- IRCCS Policlinico San Martino — Genoa
Publications
- Zahorec R. Neutrophil-to-lymphocyte ratio, past, present and future perspectives. Bratisl Lek Listy. 2021;122(7):474-488. doi: 10.4149/BLL_2021_078. PMID 34161115
Identifiers
NCT: NCT06809673 · PA.RI.GE.