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Completed

NCT Number: NCT01256801

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Gene Expression Profiling Immunotherapy Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Beijing Cancer Hospital

Beijing, 100142, China

About this study

  • 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.
  • Malignant pleural effusion from metastatic breast cancer patient is obtained through thoracentesis and is centrifugalized to enrich cancer cells before the therapy.
  • The enriched cancer cells are flash frozen and stored at -80℃ until processing.
  • The gene expression in pleural effusion is detected by microarray to screen gene markers that are differently expressed between groups .
  • Statistical analysis is performed using unsupervised hierarchical cluster.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cytokine

Biological

interleukin 2 2 million unit every week

Other names: interleukin 2 2 million unit every week

Primary outcomes

  1. immunotherapy response

    Time frame: 1 month

    Response of malignant pleural effusion to immunotherapy is evaluated with WHO guidelines

Secondary outcomes

  1. immunological status

    Time frame: 1 month

    compare the immunological status of pleural effusion before and after the therapy

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Official study title

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

Acronym: GMPE

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 9, 2010
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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