PA.RI.GE. Study. The Prognostic Role of Inflammatory Circulating Biomarkers in HNSCC: a Prospective Multicentric Trial

NCT06809673 | Enrolling By Invitation DMC

• 1 other identifier: PA.RI.GE.
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

blood sampling OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by HNSCC (larynx, oral cavity, hypopharynx) treated with primary surgery +/- adjuvant treatment. Not included patient with prior tumors or other immunosuppressive/immunostimalnt treatment or disease.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ospedale Policlinico San Martino: lead

Study Sites (1)

IRCCS Policlinico San Martino

Genoa, 16132, Italy

Location

Related Publications (1)

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

complete blood count, kidney function (creatinine and glomerular filtrate), liver function (AST/GOT, ALT/GPT, total bilirubin), lactate dehydrogenase, albumin, fibrinogen, c reactive protein. Kidney and liver function sampling will be collected only before surgery.

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)