NCT06809673Enrolling by invitation
PA.RI.GE. Study. The Prognostic Role of Inflammatory Circulating Biomarkers in HNSCC: a Prospective Multicentric Trial
Source: ClinicalTrials.gov · Last updated 5 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a clinical, observational, non-pharmacological, multicenter, prospective case-control no-profit study to assess the prognostic role of several circulating inflammatory biomarkers
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 30 Jan 2025
- Start date
- 1 Aug 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Ospedale Policlinico San Martino
- Diseases
- Head and neck cancer
- NCT number
- NCT06809673
What you commit to
- Study type: Observational
- Planned participants: 400
- From 1 Aug 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous local or systemic treatment for head and neck cancer
- Concomitant immunosuppressive treatment
- Concomitant immunostimulant treatment
- Major surgery in the previous year
Other illness
- Relapsing or metastatic disease
- Locally advanced disease not amenable to curative intent treatment
- 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
- Chronic inflammatory disease
- Autoimmune disease
- 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.
Lab values
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.