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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2029-12-31

Brief Summary

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This is a clinical, observational, non-pharmacological, multicenter, prospective case-control no-profit study to assess the prognostic role of several circulating inflammatory biomarkers

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Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No