Malignant TumorNCT01884168
Study of Gene Expression Profiling and Immunological Mechanism Affects the Response of Immunotherapy
An observational study of Malignant Tumor, run by Capital Medical University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Tumor
- What is being tested?
- Dc-CIK immunotherapy
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The malignant tumor patients present with malignant cavity effusion and can receive DC-CIK immunotherapy.
Who may be able to join
- 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.
Who cannot join
- Previous history of other malignancies.
- Serious or uncontrolled concurrent medical illness.
Trial locations and contacts
1 site in 1 country.
China1 site
Capital Medical University Cancer Center/Beijing Shijitan Hospital
Beijing, Beijing Municipality, 100038
About this study
Official title: Gene Expression Profiling and Immunological Mechanism Affects the Response of Malignant Cavity Effusion Towards DC-CIK Immunotherapy
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
- The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.
- 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.
- The enriched cancer cells which are flash frozen, as well as the supernatant, are stored at -80°C until processing.
- 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.
- Statistical analysis is performed using unsupervised hierarchical cluster.
- Conditions
- Malignant Tumor
- Being tested
- Dc-CIK immunotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dc-CIK immunotherapyBiological
The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Dc-CIK immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2022
- Study completionMay 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ren MD, PhD, Capital Medical University
- Investigators
- Jun Ren, MD, PhD, Principal investigator, Capital Medical University Cancer Center /Beijing Shijitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884168
- Sponsor's protocol ID
- GIMCEI
- Status last verified
- Feb 2024
- First submitted
- 19 Jun 2013
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Profiling and Immunological Mechanism Affects the Response of Malignant Cavity Effusion Towards DC-CIK Immunotherapy
- ClinicalTrials.gov ID
- NCT01884168
- Acronym / sponsor ID
- GIMCEI
- Conditions
- Malignant Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2022 (actual)
- Study completion
- May 2023 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.
- 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.
- The enriched cancer cells which are flash frozen, as well as the supernatant, are stored at -80°C until processing.
- 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.
- Statistical analysis is performed using unsupervised hierarchical cluster.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gene expression profile | – | Biological: Dc-CIK immunotherapyT-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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The malignant tumor patients present with malignant cavity effusion and can receive DC-CIK immunotherapy.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Previous history of other malignancies.
- Serious or uncontrolled concurrent medical illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dc-CIK immunotherapyThe patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally. | Biological | gene expression profile |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Ren, MD, PhD principal investigator
Capital Medical University Cancer Center /Beijing Shijitan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Tumor, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunotherapy response (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.