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CompletedNCT02661399Updated Dec 17, 2020

Peripheral Blood Biomarkers Associated With CIPN

An observational study in Peripheral Neuropathy, Secondary to Drugs or Chemicals, sponsored by St. Louis University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-17.

Sponsored by St. Louis University · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
100
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Peripheral Neuropathy, Secondary to Drugs or Chemicals

Keywords

  • CIPN
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In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 100 is above the median of 90 across 188 observational studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

St. Louis University is the lead sponsor of 152 studies on the registry; 17 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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).

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

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
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Study design

Observational model
Other
Time perspective
Other
Enrollment
100 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

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).

    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)

    Time frame: 3 years

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02661399
Lead sponsor
St. Louis University
Responsible party
Raymond C. Tait, PhD (Professor, St. Louis University) — Principal investigator
First posted
Jan 22, 2016
Start date
Nov 2014
Primary completion
May 8, 2017
Completion
Dec 10, 2020
Last update
Dec 17, 2020

Study contacts

Jack Lionberger, MD, PhD
principal investigator · St. Louis University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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