Non-small Cell Lung CancerNCT02803619
A Multi-center Prospective Observational Biomarker Study on EGFRm+ Non-small Cell Lung Cancer Patients With Leptomeningeal Metastasis
An observational study of Non-small Cell Lung Cancer and Leptomeningeal Metastasis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Leptomeningeal metastasis (LM) is one of the disastrous events when managing advanced Non-small cell lung cancer (NSCLC) due to a grave prognosis. Although intrathecal (IT) chemotherapy and brain and/or spinal axis irradiation show some effects for LM in advanced NSCLC, the prognosis is still poor with median survival… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-small Cell Lung Cancer, Leptomeningeal Metastasis
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Dec 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Leptomeningeal metastasis (LM) in patients with non-small cell lung cancer (NSCLC)
Who may be able to join
- The cytological identification of malignant cells within cerebrospinal fluid (CSF).
- Non-small cell lung cancer patients.
- Tumor specimens or cytology specimens can be used for the EGFR gene mutation detection.
- The entails examining cerebrospinal fluid could be obtained by lumbar puncture.
- Expected survival time is greater than 1 month.
Who cannot join
- Patients with radiologic evidence of LM not confirmed by positive CSF cytology.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Respiratory Medicine, Peking Union Medical College Hospita
Beijing, Beijing Municipality, 100730
Mengzhao Wang, MD, 010-69155039 ext. +86, mengzhaowang@sina.com
Yan Xu, MD, 18500296828 ext. +86, maraxu@163.com
About this study
Leptomeningeal metastasis (LM) is one of the disastrous events when managing advanced Non-small cell lung cancer (NSCLC) due to a grave prognosis. Although intrathecal (IT) chemotherapy and brain and/or spinal axis irradiation show some effects for LM in advanced NSCLC, the prognosis is still poor with median survival less than 12-14 weeks. Epidermal growth factor (EGFR) tyrosine kinase inhibitors (TKIs) showed to be effective for LM in selected NSCLC patients in some retrospective research. Our single-center prospective research indicated that the incidence of EGFR sensitive mutations (EGFRm+) in NSCLC-LM patients was high and EGFR-TKIs showed a survival benefit for LM in EGFRm+ NSCLC patients. A multi-center prospective observational biomarker study will be started in 11 lung cancer center based on our single-center prospective research result. The aims of the study are to find predictive biomarkers for LM in advanced NSCLC, to establish EGFR-TKIs based comprehensive treatment for appropriate EGFRm+ LM cases, and to establish effective clinical assessment criteria for NSCLC-LM EGFR-TKIs treatment.
- Keywords
- Non-small cell lung cancer, leptomeningeal metastasis, EGFR sensitive mutations
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Meningeal Carcinomatosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival after the diagnosis of leptomeningeal metastasis in NSCLC patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startNov 2013
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang mengzhao, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803619
- Sponsor's protocol ID
- ZS-595
- Status last verified
- Jun 2016
- First submitted
- 14 Jun 2016
- Last updated
- 17 Jun 2016
- Results posted
- No
Publications
Xu Y, Hu M, Zhang M, Zhong W, Yin X, Sun Y, Chen M, Zhao J, Si X, Wang H, Zhang X, Zhang L, Li J, Guan H, Yang Z, Wang M. Prospective study revealed prognostic significance of responses in leptomeningeal metastasis and clinical value of cerebrospinal fluid-based liquid biopsy. Lung Cancer. 2018 Nov;125:142-149. doi: 10.1016/j.lungcan.2018.08.017. Epub 2018 Sep 17.
PubMed 30429013
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Prospective Observational Biomarker Study on EGFRm+ Non-small Cell Lung Cancer Patients With Leptomeningeal Metastasis
- ClinicalTrials.gov ID
- NCT02803619
- Acronym / sponsor ID
- ZS-595
- Keywords
- Non-small cell lung cancer, leptomeningeal metastasis, EGFR sensitive mutations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2016 (estimated)
- First posted
- 17 Jun 2016 (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.
Leptomeningeal metastasis (LM) is one of the disastrous events when managing advanced Non-small cell lung cancer (NSCLC) due to a grave prognosis. Although intrathecal (IT) chemotherapy and brain and/or spinal axis irradiation show some effects for LM in advanced NSCLC, the prognosis is still poor with median survival less than 12-14 weeks. Epidermal growth factor (EGFR) tyrosine kinase inhibitors (TKIs) showed to be effective for LM in selected NSCLC patients in some retrospective research. Our single-center prospective research indicated that the incidence of EGFR sensitive mutations (EGFRm+) in NSCLC-LM patients was high and EGFR-TKIs showed a survival benefit for LM in EGFRm+ NSCLC patients. A multi-center prospective observational biomarker study will be started in 11 lung cancer center based on our single-center prospective research result. The aims of the study are to find predictive biomarkers for LM in advanced NSCLC, to establish EGFR-TKIs based comprehensive treatment for appropriate EGFRm+ LM cases, and to establish effective clinical assessment criteria for NSCLC-LM EGFR-TKIs treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Leptomeningeal metastasis (LM) in patients with non-small cell lung cancer (NSCLC)
Key inclusion criteria (5 listed)
- The cytological identification of malignant cells within cerebrospinal fluid (CSF).
- Non-small cell lung cancer patients.
- Tumor specimens or cytology specimens can be used for the EGFR gene mutation detection.
- The entails examining cerebrospinal fluid could be obtained by lumbar puncture.
- Expected survival time is greater than 1 month.
Key exclusion criteria (1 listed)
- Patients with radiologic evidence of LM not confirmed by positive CSF cytology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival after the diagnosis of leptomeningeal metastasis in NSCLC patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Derived from this study: PubMed 30429013Xu Y, Hu M, Zhang M, Zhong W, Yin X, Sun Y, Chen M, Zhao J, Si X, Wang H, Zhang X, Zhang L, Li J, Guan H, Yang Z, Wang M. Prospective study revealed prognostic significance of responses in leptomeningeal metastasis and clinical value of cerebrospinal fluid-based liquid biopsy. Lung Cancer. 2018 Nov;125:142-149. doi: 10.1016/j.lungcan.2018.08.017. Epub 2018 Sep 17.
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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.
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 Non-small Cell Lung Cancer and Leptomeningeal Metastasis, run by Peking Union Medical College Hospital 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Jun 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mengzhao Wang, MD (010-69155039 ext. +86, mengzhaowang@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival after the diagnosis of leptomeningeal metastasis in NSCLC patients (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02803619, which also lists 1 linked publication.
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 17 Jun 2016.