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Completed

NCT Number: NCT02661399

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.

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Key information

Conditions

Peripheral Neuropathy, Secondary to Drugs or Chemicals Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Official study title

Investigation of Peripheral Blood Biomarkers Associated With CIPN

Important dates

Study start
2014
Primary completion
2017
Study completion
2020
First posted
Jan 22, 2016
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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