Peripheral Blood Biomarkers Associated With CIPN

Completed

• Conditions: Peripheral Neuropathy, Secondary to Drugs or Chemicals

• Registration Number: NCT02661399
• Lead Sponsor: St. Louis University

Brief Summary

The investigators are doing a research study that will teach us about the tingly pain that people develop when they get chemotherapy.

Detailed Description

The investigators are asking for a blood sample, information about patients symptoms during chemotherapy, and past medical history from people who have taken or will take certain types of chemotherapy. The investigators hope to examine blood for proteins that could help us learn which patients get neurological symptoms while getting chemotherapy. The investigators' main research goal is to improve the treatment of patients getting chemotherapy to help their quality of life and/or help to increase the chance of their cancer being cured.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-22
• Primary Completion: 2017-05-08
• Status Verified: 2020-12
• Study Completion: 2020-12-10
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnosis of a tumor for which Platinums, Vinca Alkaloids, Bortezomib or Taxanes are indicated
• No prior history of diabetic, anatomical or regional neuropathies (except pre-existing CIPN)
• Age ≥ 18 years
• Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.

Exclusion Criteria

• Inability to give consent
• Inability to tolerate venipuncture for any reason
• Age < 18 years
• Any known medical, surgical or psychiatric condition that may interfere with the conduct of the study or be detrimental to the donor in the opinion of the PI or caring physician
• Consent Refusal by patient

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collection of blood samples, medical history, CIPN symptomology (via questionnaire) and clinical laboratory data for a correlative evaluation of potential CIPN related molecular and cellular variance (biomarkers).	3 years	Variant S1P/S1PR related biomarkers; CIPN Questionnaire for Blood Collection Protocol (non-standardized questionnaire, 0-4 rating scales, 0 = no symptoms, 4 = very severe symptoms, symptoms: neuropathic pain severity/unpleasantness, sharpness, depth, tingling, numbness)