NCT01884168

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

9.8 years

First QC Date

June 19, 2013

Last Update Submit

February 5, 2024

Conditions

Malignant Tumor

Outcome Measures

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

    1 month

Study Arms (1)

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

Dc-CIK immunotherapyBIOLOGICAL

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

gene expression profile

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Previous history of other malignancies.
  • Serious or uncontrolled concurrent medical illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Medical University Cancer Center/Beijing Shijitan Hospital

Beijing, Beijing Municipality, 100038, China

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Jun Ren, MD, PhD

    Capital Medical University Cancer Center /Beijing Shijitan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 19, 2013

First Posted

June 21, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2022

Study Completion

May 1, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

CN(1)