Taxane Induced Peripheral Neuropathy in Chinese Patients With Breast Cancer

NCT ID: NCT04068090

Last Updated: 2020-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-23

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with CIPN

Patients with peripheral neuropathy after treatment with taxanes

Patient Questionnaires

Intervention Type OTHER

FACT-Ntx, EORTC-CIPN20

Blood Collection

Intervention Type OTHER

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

Patient Questionnaires

Intervention Type OTHER

FACT-Ntx, EORTC-CIPN20

Blood Collection

Intervention Type OTHER

biomarker analysis

Interventions

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Patient Questionnaires

FACT-Ntx, EORTC-CIPN20

Intervention Type OTHER

Blood Collection

biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Ma Fei,MD

Deputy Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongnan Mo, MD

Role: CONTACT

+86-10-87788200

Facility Contacts

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Hongnan Mo, MD

Role: primary

8610-87788103

Other Identifiers

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TIPN in China

Identifier Type: -

Identifier Source: org_study_id

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