Taxane Induced Peripheral Neuropathy in Chinese Patients With Breast Cancer

NCT04068090 | Unknown

• 1 other identifier: TIPN in China
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

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

  Up to 2 years

Secondary Outcomes (2)

• Predictive value of genetic variants for the development of neuropathy

  In the two weeks before start treatment

• Total score from the EORTC QLQ - CIPN20 questionnaire

  Up to 2 years

Study Arms (2)

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

Patient Questionnaires OTHER

FACT-Ntx, EORTC-CIPN20

Patients with CIPN; Patients without CIPN

Blood Collection OTHER

biomarker analysis

Patients with CIPN; Patients without CIPN

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese breast cancer patients treated with taxanes

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, DNA,Peripheral Blood Mononuclear Cells (PBMC)

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Hongnan Mo, MD

CONTACT

+86-10-87788200; mhnzlyynk@outlook.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 28, 2019
• Study Start: August 23, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 30, 2020

Record last verified: 2020-03

Locations

CN (1)