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CompletedNCT01884168Updated Feb 7, 2024

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

An observational study in Malignant Tumor, sponsored by Capital Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-02-07.

Sponsored by Capital Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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.
02

Conditions studied

  • Malignant Tumor

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 30 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

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Lead sponsor

Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

  1. Previous history of other malignancies.
  2. Serious or uncontrolled concurrent medical illness.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • BiologicalDc-CIK immunotherapy

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

06

What researchers measure

Primary outcomes

  1. Immunotherapy response

    T-Cell Receptor and B-Cell Receptor gene expression profiling and the change of cytokines, lymphocytes subpopulation before and after DC-CIK infusion

    Time frame: 1 month

07

Study locations

1 site
  • Capital Medical University Cancer Center/Beijing Shijitan Hospital
    Beijing, Beijing 100038, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01884168
Lead sponsor
Capital Medical University
Responsible party
Jun Ren MD, PhD (Director, Capital Medical University) — Principal investigator
First posted
Jun 21, 2013
Start date
Mar 2013
Primary completion
Dec 2022
Completion
May 2023
Last update
Feb 7, 2024

Study contacts

Jun Ren, MD, PhD
principal investigator · Capital Medical University Cancer Center /Beijing Shijitan Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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