Biomarkers of Liposomal Doxorubicin Induced Hypersensitivity Reaction in Breast Cancer Patients

December 21, 2021 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Biomarkers Study of Liposomal Doxorubicin Injection Induced Hypersensitivity Reaction in Breast Cancer Patients

Pegylated liposomal doxorubicin (PLD) was an anthracycline nanomedicine to be approved for advanced breast cancer and other solid tumor therapy and showed a good disease control rate (57%). PLD could induce hypersensitivity reaction (HSR). There are about 9-25% patients got infusion reaction or HSR. Severe HSR could lead to allergic shock even presyncope or threat to life. To our knowledge, there were no sensitivity biomarker to predict the PLD induced HSR. And the mechanism of PLD induced HSR is unknown yet. Therefore, to analyze and discuss the biomarkers and mechanism of PLD induced HSR in advanced breast cancer, we design this prospective, observational, biomarker study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

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 Contact Backup

  • Name: Suiwen Ye
  • Phone Number: +86-13825115916

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-sen Memorial Hospital
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Advanced breast cancer patients who recieve liposomal doxorubicin treatment.

Description

Inclusion Criteria:

  • ≥18 years old; Breast cancer confirmed with histological or molecular diagnosis; Advanced breast cancer diagnosis according to American Joint Committee on cancer eighth edition cancer staging manual; Treatment with liposomal doxorubicin; No pregnancy plan and voluntary use of effective contraceptive measures during treatment

Exclusion Criteria:

  • Subjects who discontinued treatment due to previous severe adverse reactions to liposomal doxorubicin or doxorubicin; poor compliance.

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
Hypersensitivity reaction group
The patients get hypersensitivity after Pegylated liposomal doxorubicin injection.
Other: Blood sampling
Collect blood before drug injection. we do not intervene the clinical administration or drug choice or other clinical treatment.
None hypersensitivity reaction group
The patients do not get hypersensitivity after Pegylated liposomal doxorubicin injection.
Other: Blood sampling
Collect blood before drug injection. we do not intervene the clinical administration or drug choice or other clinical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The predictive biomarkers of PLD induced hypersensitivity
Time Frame: 2022.06-2023.12
Detect and analyze the association between hypersensitivity and metabonomics, anti-PEG antibody, IgE et. al
2022.06-2023.12

Collaborators and Investigators

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

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

February 7, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

December 21, 2021

First Submitted That Met QC Criteria

December 21, 2021

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

January 6, 2022

Last Update Submitted That Met QC Criteria

December 21, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YDPLD191016-I1-SYSU-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

If we found a significant, sensitive biomarker of liposomal doxorubicin induced hypersensitivity, we will share the protocol and results with other scientists or clinical researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Liposomal Doxorubicin Induced Hypersensitivity Reaction in Breast Cancer Patients

Clinical Trials on Blood sampling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe