CClinicalTrials.gg
Enrolling by invitationNCT06809673Updated Feb 5, 2025

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

An observational study in Head and Neck Cancer, sponsored by Ospedale Policlinico San Martino. Enrolling by invitation at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-05.

Sponsored by Ospedale Policlinico San Martino · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

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

02

Conditions studied

  • Head and Neck Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

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.

05

What researchers measure

Primary outcomes

  1. To identify a profile of circulating biomarkers in patients affected by HNSCC

    Time frame: 72 months

  2. To identify a subset of patients in which biomarkers modifications might anticipate disease recurrence

    Time frame: 72 months

06

Study locations

1 site
  • IRCCS Policlinico San Martino
    Genoa, 16132, Italy
07

References and documents

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. PubMed 34161115 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06809673
Lead sponsor
Ospedale Policlinico San Martino
Responsible party
Filippo Marchi (Dr, Ospedale Policlinico San Martino) — Principal investigator
First posted
Feb 5, 2025
Start date
Aug 1, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Feb 5, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion