NCT02661399

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2017

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

2.5 years

First QC Date

January 19, 2016

Last Update Submit

December 14, 2020

Conditions

Peripheral Neuropathy, Secondary to Drugs or Chemicals

Keywords

CIPN

Outcome Measures

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)

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Study Officials

  • Jack Lionberger, MD, PhD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 22, 2016

Study Start

November 1, 2014

Primary Completion

May 8, 2017

Study Completion

December 10, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12