Studying Blood Changes in Neuroendocrine Tumor Patients Before Radiation Therapy

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with neuroendocrine tumours who have had peptide receptor radionuclide therapy (PRRT) or are about to start it. It also looks for people who developed MDS or AML after PRRT.

Sex

All sexes can join.

Disease stage

Daily-life ability score (ECOG) of 0-3 and life expectancy over 6 months. Three groups: PRRT finished within 5 years, PRRT planned to start within 4 months, or MDS or AML diagnosed after earlier PRRT.

Earlier treatment

Group A: PRRT completed within 5 years before joining. Group B: PRRT planned to start within 4 months. Group C: MDS or AML diagnosed after earlier PRRT.

Biomarker or test result

Willing to have repeated blood tests with a CHIP genetic panel.

Main reasons for not taking part

• Not willing to give a blood sample
• Not willing to follow the study plan and follow-up

The registry criteria, word for word

What the trial wants to find out

This is a prospective observational study which aims to identify individuals predisposed to developing myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) could improve patient outcomes in different ways. First, it will enable improved patient selection for PRRT where alternative treatment options are available. Second, understanding the final pathway and how it is modulated by PRRT could allow the design of strategies to halt this process. Third, while it is unknown whether the development of MDS and AML is a late effect of radiopharmaceuticals in general or it is confined to cancer populations or specific radioisotopes will need to be confirmed. Finally, understanding this devastating complication is expected to be the cornerstone towards advancing radiopharmaceuticals' role in the adjuvant setting.

The 3 groups in the trial

• Previous PRRT

  Patients who have received PRRT within the last 4 years. There are no baseline levels available for cohort A patients. Sample size: 20.

  Treatment: Blood collection

• Planned for PRRT

  Patients who are scheduled to start PRRT in the next 3 months. Pre-PRRT clonal expansion status will only be available form this cohort. These patients will provide a comprehensive record of development of CH from exposure to PRRT. Sample size: 20.

  Treatment: Peptide receptor radionuclide therapy (PRRT) and Blood collection

• Post PRRT Diagnosed with t-MN (MDS or AML)

  Patients who have t-MN (MDS or AML). Sample size: 5.

  Treatment: Blood collection