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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01256801
First Posted: December 9, 2010
Last Update Posted: July 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jun Ren, Beijing Cancer Hospital
  Purpose
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.

Condition Intervention Phase
Breast Neoplasms Neoplasm Metastasis Gene Expression Profiling Immunotherapy Biological: cytokine Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gene Expression Profiling of Breast Cancer Cells in Pleural Effusion Prodict the Response of Malignant Pleural Effusion to Immunotherapy

Resource links provided by NLM:


Further study details as provided by Jun Ren, Beijing Cancer Hospital:

Primary Outcome Measures:
  • immunotherapy response [ Time Frame: 1 month ]
    Response of malignant pleural effusion to immunotherapy is evaluated with WHO guidelines


Secondary Outcome Measures:
  • immunological status [ Time Frame: 1 month ]
    compare the immunological status of pleural effusion before and after the therapy


Biospecimen Retention:   Samples Without DNA
The cancer cells are taken from the malignant pleural effusion of breast cancer patiets.

Enrollment: 36
Study Start Date: November 2010
Study Completion Date: December 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
cytokine
The patients are randomized to receive the cytokine infusion in the pleural cavity
Biological: cytokine
interleukin 2 2 million unit every week
Other Name: interleukin 2 2 million unit every week

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The breast cancer patiets present with pleural effusion and can receive chemotherapy.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256801


Locations
China
Beijing Cancer Hospital
Beijing, China, 100142
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
Study Chair: JUN REN, MD Beijing Cancer Hospital
  More Information

Responsible Party: Jun Ren, Director, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT01256801     History of Changes
Other Study ID Numbers: GMPE
First Submitted: December 1, 2010
First Posted: December 9, 2010
Last Update Posted: July 29, 2015
Last Verified: July 2015

Keywords provided by Jun Ren, Beijing Cancer Hospital:
Metastatic Breast Neoplasms
Gene Expression Profiling
immunotherapy

Additional relevant MeSH terms:
Neoplasms
Breast Neoplasms
Pleural Effusion
Neoplasm Metastasis
Pleural Effusion, Malignant
Neoplasms by Site
Breast Diseases
Skin Diseases
Pleural Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs