BLood Groups as Biomarker to Optimize Odds of Response to Anti-PD-1 Drugs

Summary

BLOOD is an investigator-initiated, multicenter, prospective biomarker study in patients with advanced melanoma treated with anti-PD-1 monotherapy in the first-line setting. The "studied products" will be administered and managed within routine medical care in Belgium. The overall goal is (i) to investigate biomarkers for anti-PD-1 monotherapy and (ii) to gather evidence on real-life use of anti-PD-1 monotherapy in melanoma.

Conditions

• Melanoma
• Cancer

Interventions

DIAGNOSTIC_TEST

Blood sample collection

Whole venous blood of participants will be collected in EDTA tubes (max. 10 mL) at baseline, before start of first immunotherapy round. The Belgian Red Cross will perform serological blood group diagnostics, and molecular RBC typing.

Sponsors & Collaborators

• Jessa Hospital

  collaborator OTHER

• University Hospital, Antwerp

  collaborator OTHER

• Algemeen Ziekenhuis Maria Middelares

  collaborator OTHER

• GZA Ziekenhuizen Campus Sint-Augustinus

  collaborator OTHER

• AZ Sint-Jan AV

  collaborator OTHER

• AZ Nikolaas

  collaborator OTHER

• AZ Sint-Lucas Gent

  collaborator OTHER

• AZ Sint-Lucas Brugge

  collaborator OTHER

• General Hospital Groeninge

  collaborator OTHER

• OLV van Lourdes Hospital Waregem

  collaborator UNKNOWN

• AZ Damiaan

  collaborator UNKNOWN

• AZ Delta

  collaborator OTHER

• ASZ Aalst

  collaborator OTHER

• Belgian Red Cross

  collaborator OTHER

• University Hospital, Ghent

  lead OTHER

Principal Investigators

• Hannelore Denys, MD, PhD · Medical Oncologist

• Emiel De Jaeghere, MD · PhD Fellow

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-01

Primary Completion

2021-04-22

Completion

2021-04-22

Countries

• Belgium

Study Locations