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Status unknownNCT04068090Updated Mar 30, 2020

Taxane Induced Peripheral Neuropathy in Chinese Patients With Breast Cancer

An observational study in Breast Cancer, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Status unknown at 1 site in China. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-30.

Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
500
Ages
16 Years and older
Sex
Female
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Study summary

The purpose of this study is to collect clinical data, blood samples, and self reported symptoms of peripheral neuropathy from Chinese patients with breast cancer after treatment with taxanes. This data will be used to develop predictive markers for neuropathy.

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Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 500 is above the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 387 studies on the registry; 275 are open to participants now.

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

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Chinese breast cancer patients treated with taxanes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of breast cancer
  • Females aged 16 and older
  • Planning to receive or previous treated with taxanes

Exclusion criteria

Exclusion Criteria:

  • Poorly controlled or insulin-dependent diabetes or other condition likely to predispose to neurotoxicity
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with CIPN

    Patients with peripheral neuropathy after treatment with taxanes

    Other: Patient Questionnaires · Other: Blood Collection

  • Patients without CIPN

    Patients treated with taxanes and don't develop will be enrolled to this cohort and matched to a specified subject with neurotoxicity based on age, tumor stage, chemotherapy regimen or total taxane dosage

    Other: Patient Questionnaires · Other: Blood Collection

Interventions

  • OtherPatient Questionnaires

    FACT-Ntx, EORTC-CIPN20

  • OtherBlood Collection

    biomarker analysis

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What researchers measure

Primary outcomes

  1. Total score from the FACT-GOG-Ntx questionnaire

    Total score from the FACT-GOG-Ntx questionnaire for peripheral neuropathy, ranging from 0-44,higher value represents a worse outcome

    Time frame: Up to 2 years

Secondary outcomes

  1. Predictive value of genetic variants for the development of neuropathy

    SNPs related to peripheral neuropathy

    Time frame: In the two weeks before start treatment

  2. Total score from the EORTC QLQ - CIPN20 questionnaire

    Total score from the EORTC QLQ - CIPN20 questionnaire for peripheral neuropathy, ranging from 20-80,higher value represents a worse outcome

    Time frame: Up to 2 years

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Study locations

1 of 1 sites recruiting
  • Cancer Hospital, Chinese Academy of Medical Sciences
    Beijing, Beijing Municipality 100021, China
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 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
NCT04068090
Responsible party
Ma Fei,MD (Deputy Director, Cancer Institute and Hospital, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Aug 28, 2019
Start date
Aug 23, 2019
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Mar 30, 2020

Study contacts

Hongnan Mo, MD
Contact
mhnzlyynk@outlook.com
+86-10-87788200

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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