Evaluating Myelodysplastic Syndrome Risks in NET Patients Planned for Peptide Radionuclide Therapy

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Diagnostic test
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• ECOG 0-3

• Life expectancy \> 6 months

• Informed consent and willingness to undergoing serial genetic panel CHIP testing.

• Cohort Specific criteria

‣ Cohort A: PRRT completed within 5 years of enrolment

⁃ Cohort B: PRRT planned to commence within 4 months of enrolment

⁃ Cohort C: diagnosis of MDS or AML following prior PRRT.

Locations
Other Locations
Canada
Princess Margaret Cancer Centre
RECRUITING
Toronto
Contact Information
Primary
Rebecca Wong
rebecca.wong@uhn.ca
416-946-4501
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 45
Treatments
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.
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.
Post PRRT Diagnosed with t-MN (MDS or AML)
Patients who have t-MN (MDS or AML). Sample size: 5.
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov