Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 29113 for:    Immunologic Factors

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment
Malignant Tumor Biological: 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gene Expression Profiling and Immunological Mechanism Affects the Response of Malignant Cavity Effusion Towards DC-CIK Immunotherapy
Study Start Date : March 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884168


Contacts
Layout table for location contacts
Contact: Jun Ren, MD, PhD 86-10-63926317 renjun9688@yahoo.com

Locations
Layout table for location information
China, Beijing
Capital Medical University Cancer Center/Beijing Shijitan Hospital Recruiting
Beijing, Beijing, China, 100038
Contact: Jun Ren, MD, PhD    86-10-63926317    renjun9688@yahoo.com   
Sponsors and Collaborators
Capital Medical University
Investigators
Layout table for investigator information
Principal Investigator: Jun Ren, MD, PhD Capital Medical University Cancer Center /Beijing Shijitan Hospital

Layout table for additonal information
Responsible Party: Jun Ren MD, PhD, Director, Capital Medical University
ClinicalTrials.gov Identifier: NCT01884168     History of Changes
Other Study ID Numbers: GIMCEI
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Immunologic Factors
Physiological Effects of Drugs