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

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ClinicalTrials.gov Identifier: NCT01884168
Recruitment Status : Recruiting
First Posted : June 21, 2013
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Jun Ren MD, PhD, Capital Medical University

Tracking Information
First Submitted Date June 19, 2013
First Posted Date June 21, 2013
Last Update Posted Date July 19, 2018
Study Start Date March 2013
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2013)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01884168 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Gene Expression Profiling and Immunological Mechanism Affects the Response of Immunotherapy
Official Title Gene Expression Profiling and Immunological Mechanism Affects the Response of Malignant Cavity Effusion Towards DC-CIK Immunotherapy
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The malignant tumor patients present with malignant cavity effusion and can receive DC-CIK immunotherapy.
Condition Malignant Tumor
Intervention Biological: Dc-CIK immunotherapy
The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.
Study Groups/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.
Intervention: Biological: Dc-CIK immunotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 19, 2013)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jun Ren, MD, PhD 86-10-63926317 renjun9688@yahoo.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01884168
Other Study ID Numbers GIMCEI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jun Ren MD, PhD, Capital Medical University
Study Sponsor Capital Medical University
Collaborators Not Provided
Investigators
Principal Investigator: Jun Ren, MD, PhD Capital Medical University Cancer Center /Beijing Shijitan Hospital
PRS Account Capital Medical University
Verification Date July 2018