National Cheng Kung University Hospital
Tainan, 704, Taiwan
NCT Number: NCT02481336
To study the risk prediction of chemotherapy-induced peripheral neuropathy (CIPN) by the clinical bioinformatics and genomic profile.
This study is active but is not currently recruiting participants.
20 year and older
All sexes
Observational
Tainan, 704, Taiwan
This is a prospective, observational, cohort study, monitoring the chemotherapy-induced peripheral neurotoxicity by traditional clinical scales, neurological examinations, and semi-quantitative assessments. Moreover, all the genetic changes will be analyzed by next generation sequencing and we will try to identify relevant variants in individuals who suffer from chemotherapy-induced neurotoxicity.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Bone marrow:
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L WBC ≥ 3.0 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin ≥ 9 g/dL
Hepatic:
Total bilirubin level ≤ 1.0 x UNL AST and ALT ≤ 3.0 x UNL
Renal:
Creatinine level ≤ 1.5 mg/dL in men, ≤1.4 mg/dL in women; or Estimated CCr ≥ 60 mL/min (CCr is estimated by Cockcroft-Gault formula, as appendix III).
Exclusion criteria
EORTC CIPN20 and EQ-5D-3L
nerve conduction velocity (NCV), quantitative sensory test (QST), and nerve excitability test (NET)
Genetic Test : 10 mL blood will be collected in Blood Sample Collection
Time frame: up to 2 years after chemotherapy
Time frame: up to 2 years after chemotherapy
Time frame: up to 2 years after chemotherapy
Time frame: up to 2 years after chemotherapy
Time frame: up to 2 years after chemotherapy
Time frame: up to 2 years after chemotherapy
Time frame: up to 5 years after chemotherapy
Time frame: up to 5 years after chemotherapy
National Cheng-Kung University Hospital
Other
Integrating Clinical and Genomic Profiles for Prediction and Prevention of Chemotherapy-induced Neuropathy Via Big Bio-Data Analytics
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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