iPSC Neurons From Adult Survivors of Childhood Cancer Who Have Persistent Vincristine-Induced Neuropathy
NCT ID: NCT02564484
Last Updated: 2024-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
137 participants
OBSERVATIONAL
2016-02-08
2024-07-09
Brief Summary
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Investigators will assess the effects of inherited genome variations on treatment-induced peripheral neuropathy that persists in adults who were cured of childhood cancer. Cells from childhood cancer survivors who did or did not develop drug-induced neuropathy will be isolated and induced to become neurons. Cell sensitivity to anticancer agents will be tested in both groups and compared to determine if the survivors have genetic variants that correspond to those identified in companion genomic studies. This will assist in determining if gene variants increase the risk of treatment-induced neurotoxicity.
The investigators are interested in detecting changes of phenotype pre-post treatment in each group (cases, controls) respectively, as well in comparing the pre-post treatment phenotypic changes between the two groups (cases vs. controls).
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Detailed Description
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PRIMARY OBJECTIVE:
* To establish induced pluripotent stem cells (iPSCs) from childhood cancer survivors who did or did not develop persistent treatment-induced peripheral neuropathy, from which to make human neurons to assess their sensitivity to vincristine and determine whether neurons from patients who developed neuropathy are more sensitive to vincristine or other neurotoxic chemotherapy.
SECONDARY OBJECTIVE:
* To evaluate the iPSC neurons made from patients with persistent treatment-related neuropathy and iPSC neurons from patients who did not develop neuropathy from the same treatment, for phenotypic difference prior to and after exposure to vincristine or other potentially neurotoxic medications.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Neuropathy
Adult survivors who developed persistent treatment-related neuropathy.
No interventions assigned to this group
Control
Adult survivors who did not develop persistent treatment-related neuropathy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Presence of any neuromotor, neurocortical, or neurocerebellar toxicity after vincristine treatment (either acute and/or persistent neuropathy)
* At least 50% of the persistent vincristine neuropathy cases will have the CEP72 promoter variant (rs924607) or a coding variant in CEP72 that is predicted to be damaging (CADD score \>9). The balance of neuropathy cases will either have variants in other genes that are associated with vincristine neuropathy identified in the ongoing genome-wide association study (GWAS) of 1250 St. Jude Life ALL survivors, or have neuropathy in the absence of known genetic variants altering the risk of neuropathy.
* Patient understands the nature of the study and provides informed consent
* Adult survivor of childhood diagnosis of ALL
* Absence of persistent neurotoxicity (grade 0) after completion of a standard vincristine-containing chemotherapy regimen (may or may not have experience acute neuropathy during treatment.
* Matched to a specified subject with neurotoxicity based on age (within 5 years), tumor type, chemotherapy regimen or total vincristine dosage, race and ethnicity.
* At least 50% of the controls will have the CEP72 promoter variant T/T genotype (at rs924607) or a coding variant in CEP72 that is predicted to be damaging (CADD score \>9). The balance of controls will either have variants in other genes that are associated with vincristine neuropathy identified in the ongoing GWAS of 1250 St. Jude Life ALL survivors, or will not have a known genetic variant altering the risk of neuropathy.
* Patient understands the nature of the study and provides informed consent
Inclusion of Women and Minorities:
* Individuals of both genders, all races and ethnic groups are eligible for this protocol.
Exclusion Criteria
* Presence of peripheral neuropathy prior to vincristine therapy
* Poorly controlled or insulin-dependent diabetes or other condition likely to predispose to neurotoxicity
* Pregnant females
* Currently receiving treatment for cancer
18 Years
ALL
No
Sponsors
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University of Chicago
OTHER
National Cancer Institute (NCI)
NIH
St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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William E. Evans, PharmD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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SJLPSC
Identifier Type: -
Identifier Source: org_study_id
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