Breast NeoplasmsGMPENCT01256801
Gene Expression Profiling of Breast Cancer Cells Predict the Response of Malignant Pleural Effusion
An observational study of Breast Neoplasms and Neoplasm Metastasis, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The investigators want to develop a gene expression profile for the prediction of immunotherapy response of patients with metastatic breast cancer presenting malignant pleural effusion. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms, Neoplasm Metastasis, Gene Expression Profiling
- What is being tested?
- cytokine
- Type of treatment
- Injection or infusion
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Nov 2010to Dec 2013
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The breast cancer patiets present with pleural effusion and can receive chemotherapy.
Who may be able to join
- Patients should be histologically confirmed with metastatic breast cancer and malignant pleural effusion
- an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- At least one measurable lesion;
- Normal cardiac, hepatic, renal and bone marrow functions;
- Life expectancy ≥3 months;
- Discontinuity of previous chemotherapy for a minimum of 4 weeks.
- Not receive chemotherapy in pleural cavity
Who cannot join
- previous history of other malignancies;
- previous surgery history on the needle biopsy organ;
- Serious or uncontrolled concurrent medical illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gene Expression Profiling of Breast Cancer Cells in Pleural Effusion Prodict the Response of Malignant Pleural Effusion to Immunotherapy
The investigators want to develop a gene expression profile for the prediction of immunotherapy response of patients with metastatic breast cancer presenting malignant pleural effusion.
Read the detailed description
- The patiets with malignant pleural effusion are randomizned to be treated with cytokins(inteleukin 2) or dendritic cells(DC) plus cytokine induced killer cells(CIK) locally.
- Malignant pleural effusion from metastatic breast cancer patient is obtained through thoracentesis and is centrifugalized to enrich cancer cells before the therapy.
- The enriched cancer cells are flash frozen and stored at -80℃ until processing.
- The gene expression in pleural effusion is detected by microarray to screen gene markers that are differently expressed between groups .
- Statistical analysis is performed using unsupervised hierarchical cluster.
- Being tested
- cytokine
- Keywords
- Metastatic Breast Neoplasms, Gene Expression Profiling, immunotherapy
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytokineBiological
Also called interleukin 2 2 million unit every week
interleukin 2 2 million unit every week
| Study group | Role | What they receive |
|---|---|---|
| cytokine | The patients are randomized to receive the cytokine infusion in the pleural cavity Receives: Biological: cytokine |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunotherapy response
Response of malignant pleural effusion to immunotherapy is evaluated with WHO guidelines
Measured: 1 month
Secondary outcomes (1)
immunological status
compare the immunological status of pleural effusion before and after the therapy
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 posted9 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ren, Peking University Cancer Hospital & Institute
- Investigators
- JUN REN, MD, Study chair, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256801
- Sponsor's protocol ID
- GMPE
- Acronym
- GMPE
- Status last verified
- Jul 2015
- First submitted
- 1 Dec 2010
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Profiling of Breast Cancer Cells in Pleural Effusion Prodict the Response of Malignant Pleural Effusion to Immunotherapy
- ClinicalTrials.gov ID
- NCT01256801
- Acronym / sponsor ID
- GMPE / GMPE
- Keywords
- Metastatic Breast Neoplasms, Gene Expression Profiling, immunotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Dec 2010 (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.
The investigators want to develop a gene expression profile for the prediction of immunotherapy response of patients with metastatic breast cancer presenting malignant pleural effusion.
Detailed description
- The patiets with malignant pleural effusion are randomizned to be treated with cytokins(inteleukin 2) or dendritic cells(DC) plus cytokine induced killer cells(CIK) locally.
- Malignant pleural effusion from metastatic breast cancer patient is obtained through thoracentesis and is centrifugalized to enrich cancer cells before the therapy.
- The enriched cancer cells are flash frozen and stored at -80℃ until processing.
- The gene expression in pleural effusion is detected by microarray to screen gene markers that are differently expressed between groups .
- Statistical analysis is performed using unsupervised hierarchical cluster.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cytokine | – | Biological: cytokineThe patients are randomized to receive the cytokine infusion in the pleural cavity |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The breast cancer patiets present with pleural effusion and can receive chemotherapy.
Key inclusion criteria (7 listed)
- Patients should be histologically confirmed with metastatic breast cancer and malignant pleural effusion
- an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- At least one measurable lesion;
- Normal cardiac, hepatic, renal and bone marrow functions;
- Life expectancy ≥3 months;
Key exclusion criteria (3 listed)
- previous history of other malignancies;
- previous surgery history on the needle biopsy organ;
- 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 |
|---|---|---|
| cytokineAlso: interleukin 2 2 million unit every weekinterleukin 2 2 million unit every week | Biological | cytokine |
Primary outcome
immunotherapy response
Time frame: 1 month
Response of malignant pleural effusion to immunotherapy is evaluated with WHO guidelines
1 secondary outcome
immunological status
Time frame: 1 month
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 29 Jul 2015.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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 study chair
Peking University Cancer Hospital & Institute
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 Breast Neoplasms and Neoplasm Metastasis, run by Peking University Cancer Hospital & Institute 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 7 inclusion and 3 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 29 Jul 2015. 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 29 Jul 2015.