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Gene Expression Profiling of Malignant Tumor Predict the Therapeutic Response of DC-CIK Immunotherapy

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ClinicalTrials.gov Identifier: NCT01906632
Recruitment Status : Recruiting
First Posted : July 24, 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 after DC-CIK immunotherapy.

Condition or disease Intervention/treatment Phase
Malignant Tumor Biological: DC-CIK Immunotherapy Not Applicable

Detailed Description:
  1. The patients with malignant tumor are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) .
  2. Venous blood (4 ml) is collected from each subject and placed into tubes containing Ethylene Diamine Tetraacetic Acid(EDTA) before and after each treatment. Lymphocytes are sorted by Fluorescence Activated Cell Sorting(FACS) and stored at -80°C until processing.
  3. The T-Cell Receptor/B-Cell Receptor gene expression is detected by micro-array。
  4. Estimate Immunotherapy response, time to disease progression, survival rates and clinical benefit response on patients. Response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Degree of response is used to divide the cancers into two groups: sensitive and non-sensitive to immunotherapy.
  5. Compare the gene expression profile between different immunotherapy response groups to explore the mechanism that predict the DC-CIK immunotherapy response.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2013
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
gene expression profile Biological: DC-CIK Immunotherapy



Primary Outcome Measures :
  1. T-Cell Receptor/B-Cell Receptor gene expression [ Time Frame: 3 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically confirmed with malignant tumor;
  • Age: 18-80 years;
  • an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  • At least one measurable lesion according to the RECIST criteria;
  • Adequate bone marrow, cardiac, liver, and renal function;
  • Life expectancy ≥2 months;
  • Not received other anti-tumor treatment
  • Informed consent signed

Exclusion Criteria:

  • previous history of other malignancies;
  • Uncontrolled central nervous system metastases;
  • 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): NCT01906632


Contacts
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Contact: Jun Ren, MD, PhD 86-10-63926317 renjun9688@yahoo.com

Locations
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China
Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital Recruiting
Beijing, China, 100038
Contact: Jun Ren, MD, PhD    86-10-63926317    renjun9688@yahoo.com   
Sponsors and Collaborators
Capital Medical University

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Responsible Party: Jun Ren MD, PhD, Director, Capita Medical University Cancer Center, Capital Medical University
ClinicalTrials.gov Identifier: NCT01906632     History of Changes
Other Study ID Numbers: GIMC
First Posted: July 24, 2013    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Neoplasms