Peripheral Blood Biomarkers Associated With CIPN

Investigation of Peripheral Blood Biomarkers Associated With CIPN

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02661399

Enrollment

100

Registered

2016-01-22

Start date

2014-11-30

Completion date

2020-12-10

Last updated

2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Neuropathy, Secondary to Drugs or Chemicals

Keywords

CIPN

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Outcome results