Gene Expression Profiling of Breast Cancer Cells Predict the Response of Malignant Pleural Effusion (GMPE)

July 27, 2015 updated by: Jun Ren, Peking University Cancer Hospital & Institute

Gene Expression Profiling of Breast Cancer Cells in Pleural Effusion Prodict the Response of Malignant Pleural Effusion to Immunotherapy

The investigators want to develop a gene expression profile for the prediction of immunotherapy response of patients with metastatic breast cancer presenting malignant pleural effusion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. The patiets with malignant pleural effusion are randomizned to be treated with cytokins(inteleukin 2) or dendritic cells(DC) plus cytokine induced killer cells(CIK) locally.
  2. Malignant pleural effusion from metastatic breast cancer patient is obtained through thoracentesis and is centrifugalized to enrich cancer cells before the therapy.
  3. The enriched cancer cells are flash frozen and stored at -80℃ until processing.
  4. The gene expression in pleural effusion is detected by microarray to screen gene markers that are differently expressed between groups .
  5. Statistical analysis is performed using unsupervised hierarchical cluster.

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

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

Study Locations

  • China
      • Beijing, China, 100142
        • Beijing Cancer Hospital

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The breast cancer patiets present with pleural effusion and can receive chemotherapy.

Description

Inclusion Criteria:

  • Patients should be histologically confirmed with metastatic breast cancer and malignant pleural effusion
  • an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  • At least one measurable lesion;
  • Normal cardiac, hepatic, renal and bone marrow functions;
  • Life expectancy ≥3 months;
  • Discontinuity of previous chemotherapy for a minimum of 4 weeks.
  • Not receive chemotherapy in pleural cavity

Exclusion Criteria:

  • previous history of other malignancies;
  • previous surgery history on the needle biopsy organ;
  • Serious or uncontrolled concurrent medical illness.

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
cytokine
The patients are randomized to receive the cytokine infusion in the pleural cavity
Biological: cytokine
interleukin 2 2 million unit every week
Other Names:
  • interleukin 2 2 million unit every week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
immunotherapy response
Time Frame: 1 month
Response of malignant pleural effusion to immunotherapy is evaluated with WHO guidelines
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
immunological status
Time Frame: 1 month
compare the immunological status of pleural effusion before and after the therapy
1 month

Collaborators and Investigators

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

Sponsor

Peking University Cancer Hospital & Institute

Investigators

  • Study Chair: Jun Ren, MD, Peking University Cancer Hospital & Institute

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

November 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 1, 2010

First Submitted That Met QC Criteria

December 8, 2010

First Posted (Estimate)

December 9, 2010

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMPE

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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