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

NCT ID: NCT01884168

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malignant Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Dc-CIK immunotherapy

Intervention Type BIOLOGICAL

The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.

Interventions

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Dc-CIK immunotherapy

The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jun Ren MD, PhD

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun Ren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Capital Medical University Cancer Center /Beijing Shijitan Hospital

Locations

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Capital Medical University Cancer Center/Beijing Shijitan Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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GIMCEI

Identifier Type: -

Identifier Source: org_study_id

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