Glioma of BrainNCT03949192
Efficacy of Kangliuwan for Recurrent Grade IV Glioma
An observational study of Glioma of Brain and Recurrence, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
A Prospective Exploratory Clinical Study to explore the efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioma of Brain, Recurrence
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2019to Jun 2021
- 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: Recurrent grade IV glioma patients and conventional treatment is invalid.
Who may be able to join
- The patient signed "informed consent" voluntarily;
- The age of patient is between 18 and 80 years;
- KPS score ≥40 ; The patient has normal liver and kidney function Normal heart function Better follow-up and compliance;
Who cannot join
- The patient did not sign "informed consent" or signed unvoluntarily.
- Non-glioma patients
- Active infection
- Human immunodeficiency virus (HIV) positive
- Hepatitis C or hepatitis B infective
- Pregnancy or breast-feeding women
Show all 9Show fewer
- Patients did not agree to use effective contraception during treatment and the following 3 months.
- Patients also participated in other clinical studies.
- The subjects researchers believe are not suitable for participation or completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital
Beijing, Beijing Municipality, 100054
Ge Sun, B.A., 8610-83168899, sunge@163.com
About this study
Official title: Efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma: A Prospective Exploratory Clinical Study
A Prospective Exploratory Clinical Study to explore the efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma.
- Conditions
- Glioma of Brain, Recurrence
- Medical subject headings
- Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in tumor volume
the volume of tumor decreased after taking Kangliuwan
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start28 Jun 2019
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma of BrainStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingtang Lin, Xuanwu Hospital, Beijing
- Investigators
- Qingtang Lin, M.D., Ph.D., Study chair, Xuanwu Hospital, BeijingXiaolan Lin, M.D., Principal investigator, Xuanwu Hospital, BeijingLing Chen, M.D., Principal investigator, The General Hospital of People's Liberation Army (301 hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949192
- Sponsor's protocol ID
- LYS [2019] 027
- Status last verified
- Apr 2020
- First submitted
- 11 May 2019
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma: A Prospective Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT03949192
- Acronym / sponsor ID
- LYS [2019] 027
- Conditions
- Glioma of Brain, Recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 14 May 2019 (actual)
- 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.
A Prospective Exploratory Clinical Study to explore the efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recurrent grade IV glioma patients and conventional treatment is invalid.
Key inclusion criteria (3 listed)
- The patient signed "informed consent" voluntarily;
- The age of patient is between 18 and 80 years;
- KPS score ≥40 ; The patient has normal liver and kidney function Normal heart function Better follow-up and compliance;
Key exclusion criteria (9 listed)
- The patient did not sign "informed consent" or signed unvoluntarily.
- Non-glioma patients
- Active infection
- Human immunodeficiency virus (HIV) positive
- Hepatitis C or hepatitis B infective
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
Changes in tumor volume
Time frame: 3 months
the volume of tumor decreased after taking Kangliuwan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
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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.
Qingtang Lin, M.D., Ph.D. study chair
Xuanwu Hospital, Beijing
Xiaolan Lin, M.D. principal investigator
Xuanwu Hospital, Beijing
Ling Chen, M.D. principal investigator
The General Hospital of People's Liberation Army (301 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 Glioma of Brain and Recurrence, run by Xuanwu Hospital, Beijing 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 3 inclusion and 9 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 5 May 2020. 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 Qingtang Lin, MD. Ph.D (8610-83198362, linqingtang@xwhosp.orn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in tumor volume (time frame: 3 months). 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 5 May 2020.