Peripheral Blood Biomarkers Associated With CIPN

Investigation of Peripheral Blood Biomarkers Associated With CIPN

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

Study Overview

• Status: Completed
• Conditions: Peripheral Neuropathy, Secondary to Drugs or Chemicals

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 Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have diagnoses which might be treated with CIPN causing therapy, and/or who have CIPN symptoms without potential confounding neuropathies (antecedent diabetic or anatomical peripheral neuropathies).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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)	3 years

Collaborators and Investigators

• Sponsor: St. Louis University
• Investigators: Principal Investigator: Jack Lionberger, MD, PhD, St. Louis University

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): May 8, 2017
• Study Completion (Actual): December 10, 2020

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: January 21, 2016
• First Posted (Estimate): January 22, 2016

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: CIPN
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: 24834