Study of Gene Expression Profiling and Immunological Mechanism Affects the Response of Immunotherapy

February 5, 2024 updated by: Jun Ren MD, PhD, Capital Medical University

Gene Expression Profiling and Immunological Mechanism Affects the Response of Malignant Cavity Effusion Towards DC-CIK Immunotherapy

To investigate gene expression profile and immunological associated analysis relating to immunotherapy response of patients with malignant tumor presenting malignant cavity effusion after DC-CIK immunotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.
  2. Malignant cavity effusion from cancer patients is obtained through puncture and is centrifugalized to get supernatant fluid and enrich cancer cells before and after the therapy.
  3. The enriched cancer cells which are flash frozen, as well as the supernatant, are stored at -80°C until processing.
  4. The T-Cell Receptor/B-Cell Receptor gene expression in cavity effusion is detected by micro-array to explore the mechanism that DC-CIK immunotherapy controls the malignant cavity effusion.
  5. Statistical analysis is performed using unsupervised hierarchical cluster.

Study Type

Observational

Enrollment (Actual)

30

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
      • Beijing, Beijing, China, 100038
        • Capital Medical University Cancer Center/Beijing Shijitan 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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The malignant tumor patients present with malignant cavity effusion and can receive DC-CIK immunotherapy.

Description

Inclusion Criteria:

  1. Histologically confirmed with malignant tumor and malignant cavity effusion.
  2. An Eastern Cooperative Oncology Group（ECOG）performance status of 0-2.
  3. Normal cardiac, hepatic, renal and bone marrow functions.
  4. Life expectancy >3 months.
  5. Not receive other anti-tumor treatment.
  6. Not receive chemotherapy in pleural and abdominal cavity.

Exclusion Criteria:

  1. Previous history of other malignancies.
  2. 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
gene expression profile
T-Cell Receptor/B-Cell Receptor gene expression in cavity effusion is detected by micro-array to explore the mechanism that DC-CIK immunotherapy controls the malignant cavity effusion.
Biological: Dc-CIK immunotherapy
The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunotherapy response
Time Frame: 1 month
T-Cell Receptor and B-Cell Receptor gene expression profiling and the change of cytokines, lymphocytes subpopulation before and after DC-CIK infusion
1 month

Collaborators and Investigators

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

Sponsor

Capital Medical University

Investigators

  • Principal Investigator: Jun Ren, MD, PhD, Capital Medical University Cancer Center /Beijing Shijitan Hospital

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

March 1, 2013

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

June 19, 2013

First Submitted That Met QC Criteria

June 19, 2013

First Posted (Estimated)

June 21, 2013

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIMCEI

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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