Actively Recruiting

Age: 18Years +
All Genders
ID07485114

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma, Non Small Cell Lung Cancer, and Hepatocellular Carcinoma Treated With PD-1/PDL-1 Inhibitors

Led by Daniel Keizman · Updated on 2026-03-20

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the role of Galectin-3 (Gal-3), a protein involved in cell processes and immune regulation, in patients with renal cell carcinoma, transitional cell carcinoma, non small cell lung cancer, and hepatocellular carcinoma treated with PD-1/PDL-1 inhibitors. The study aims to understand how Gal-3 levels relate to treatment response, survival, and side effects, as Gal-3 may affect tumor progression and reduce the effectiveness of immunotherapy. This observational study involves measuring Gal-3 blood levels using an FDA-approved automated system called the Architect platform, ensuring accurate and consistent results. Blood samples are collected before each PD-1/PDL-1 inhibitor treatment and stored for analysis. Clinical and laboratory data, including liver function and adverse events, are also collected throughout the study period. Participants will be monitored over three years with regular blood draws and clinical evaluations before each immunotherapy cycle. Researchers will analyze the correlation between Gal-3 levels and patient outcomes such as treatment response and side effects. The study seeks to improve understanding of how Gal-3 influences immunotherapy results to optimize future treatments for these cancers.

CONDITIONS

Brief Title

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must be able to read and understand the informed consent form (ICF) and follow protocol requirements
  • Patients aged 18 years or older
  • Patients diagnosed with renal cell carcinoma, transitional cell carcinoma, non small cell lung cancer, or hepatocellular carcinoma
  • Patients treated with PD-1/PDL-1 inhibitors
  • Patients prior to receiving the first cycle of PD-1/PDL-1 inhibitors
  • Willingness to participate throughout the study duration
Not Eligible

You will not qualify if you...

  • Female participants who are pregnant, breastfeeding, or planning pregnancy during the study period
  • Male participants whose partners are planning pregnancy during the study period
  • Female participants of child-bearing potential who cannot agree to use reliable birth control during the study and for 1 month after the last dose

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - 3 years

Blood tests are performed to measure serum Galectin-3 levels, blood count, and liver function.

Long-term Monitoring

Duration - 3 years

Participants are monitored over time to analyze Galectin-3 level fluctuations and correlate these with treatment outcomes and side effects during PD-1/PDL-1 inhibitor therapy.

Trial Site Locations

Total: 1 location

1

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, Israel, 64239

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Research Team

D

Daniel Keizman, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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