New Preclinical and Clinical Approaches to Mesothelioma

Last updated: July 31, 2024
Sponsor: Marco Emilio Bianchi
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Cancer

Mesothelioma

Treatment

N/A

Clinical Study ID

NCT06536179
PNRR-TR1-2023-12377199
  • All Genders

Study Summary

This study protocol involves the coordination between UO1 (IRCCS San Raffaele Hospital) and UO2 (Istituto Nazionale Tumori di Napoli - IRCCS G. Pascale) to explore the role of HMGB1 and CXCR4 in cancer treatment and metastasis. UO1 focuses on the role of HMGB1 in inflammation, mesothelioma progression, and tissue repair, as well as developing, in future, possible HMGB1 inhibitors for cancer therapy. UO2 specializes in CXCR4's role in cancer, developing CXCR4 antagonists, and tracking CXCR4-dependent metastasis. The hypothesis is that targeting HMGB1 and CXCR4 pathways will inhibit tumor progression and metastasis, enhancing anti-tumor immunity and improving therapeutic outcomes in cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with Mesothelioma:

Clinical suspicion or histologically confirmed diagnosis of pleural mesothelioma.

  • Candidates for surgical intervention.

  • Age 18 years or older. It is possible to include both male and female patients, maleand female patients of reproductive age, as well as breastfeeding women.

  • Capacity to comprehend the study nature and provide autonomously informed consent.

Control Group patients:

  • Absence of pleural mesothelioma but presence of other histologically confirmeddiseases (neoplastic, inflammatory, or infectious).

  • Candidates for surgical intervention.

  • Age 18 years or older. It is possible to include both male and female patients, maleand female patients of reproductive age, as well breastfeeding women.

  • Ability to understand the study nature and provide autonomously informed consent.

If the patient's diagnosis, whether provisional or definitive, does not confirm the clinical suspicion, they will not undergo further evaluation in the study.

Exclusion

Exclusion Criteria:

  • Lack of biopsy material.

  • pregnancy.

  • Unwillingness to sign the Informed Consent.

Study Design

Total Participants: 70
Study Start date:
July 25, 2024
Estimated Completion Date:
January 25, 2027

Study Description

This is a multicentric cross-sectional observational study with an additional blood volume collected during blood sampling performed for normal clinical practice. The enrollment will take

Connect with a study center

  • Istituto Nazionale Tumori IRCCS Fondazione G.Pascale

    Napoli, Campania 80131
    Italy

    Active - Recruiting

  • IRCCS San Raffaele

    Milan, Lombardia 20132
    Italy

    Active - Recruiting

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