Taxane Induced Peripheral Neuropathy in Chinese Patients With Breast Cancer

March 26, 2020 updated by: Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Chinese breast cancer patients treated with taxanes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with CIPN
Patients with peripheral neuropathy after treatment with taxanes
Other: Patient Questionnaires
FACT-Ntx, EORTC-CIPN20
Other: Blood Collection
biomarker analysis
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
FACT-Ntx, EORTC-CIPN20
Other: Blood Collection
biomarker analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total score from the FACT-GOG-Ntx questionnaire
Time Frame: Up to 2 years
Total score from the FACT-GOG-Ntx questionnaire for peripheral neuropathy, ranging from 0-44,higher value represents a worse outcome
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive value of genetic variants for the development of neuropathy
Time Frame: In the two weeks before start treatment
SNPs related to peripheral neuropathy
In the two weeks before start treatment
Total score from the EORTC QLQ - CIPN20 questionnaire
Time Frame: Up to 2 years
Total score from the EORTC QLQ - CIPN20 questionnaire for peripheral neuropathy, ranging from 20-80,higher value represents a worse outcome
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 23, 2019

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

August 15, 2019

First Submitted That Met QC Criteria

August 23, 2019

First Posted (ACTUAL)

August 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 26, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIPN in China

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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