Lung CancerNCT04568291
CTC in Lung Caner Patients With Bone Metastases
A study testing model treatment and routine treatment in people with Lung Cancer and Bone Metastases, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
1. Evaluate the feasibility of single cell sequencing technology based on three-dimensional bionic capture network; 2. To build a risk prediction model of bone related events based on single cell sequencing; 3. To verify the risk prediction model of bone related events by single cell sequencing; 4. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Bone Metastases, Single Cell Sequencing Technology
- What is being tested?
- model treatment and routine treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 31 Dec 2022
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-75 years
- pathology-proven diagnosis of lung cancer and radiographical/pathological evidence of BM
- no previous treatment for BM
- good general condition (Eastern Cooperative Oncology Group, ECOG Performance scores: 0-2) with an estimated survival time > 3 months.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People'S Hospital
Shanghai, Other (Non U.s.), 200233
hui zhao, 13564460369, areyouwangzhiyu@163.com
About this study
Official title: Clinical Reasearch on Three Dimensional Bionic Capture Network Circulating Tumor Cell in Lung Caner Patients With Bone Metastases
- Evaluate the feasibility of single cell sequencing technology based on three-dimensional bionic capture network;
- To build a risk prediction model of bone related events based on single cell sequencing;
- To verify the risk prediction model of bone related events by single cell sequencing;
- To verify the comprehensive treatment of non-small cell lung cancer ( NSCLC) bone metastases.
- Being tested
- model treatment, routine treatment
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
model treatmentOther
the treatment decisions were decided by Machine Learning （ML） model in model treatment group
routine treatmentOther
the treatment decisions were decided by multi-disciplinary team （MDT）
| Study group | Role | What they receive |
|---|---|---|
| routine treatment | Active comparator | routine treatment Receives: Other: routine treatment |
| model treatment | Experimental | model treatment Receives: Other: model treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
SREs（Skeletal related events）
occurance of SREs，including bone pain, pathological fractures, spinal cord compression, hypercalcemia, and the need for surgery or radiotherapy
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 posted29 Sep 2020
- Study start1 Oct 2020
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Hui, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568291
- Sponsor's protocol ID
- CTC01
- Status last verified
- Aug 2021
- First submitted
- 6 Mar 2020
- Last updated
- 12 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Reasearch on Three Dimensional Bionic Capture Network Circulating Tumor Cell in Lung Caner Patients With Bone Metastases
- ClinicalTrials.gov ID
- NCT04568291
- Acronym / sponsor ID
- CTC01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 29 Sep 2020 (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.
- Evaluate the feasibility of single cell sequencing technology based on three-dimensional bionic capture network;
- To build a risk prediction model of bone related events based on single cell sequencing;
- To verify the risk prediction model of bone related events by single cell sequencing;
- To verify the comprehensive treatment of non-small cell lung cancer ( NSCLC) bone metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine treatment | Active comparator | Other: routine treatmentroutine treatment |
| model treatment | Experimental | Other: model treatmentmodel treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18-75 years
- pathology-proven diagnosis of lung cancer and radiographical/pathological evidence of BM
- no previous treatment for BM
- good general condition (Eastern Cooperative Oncology Group, ECOG Performance scores: 0-2) with an estimated survival time > 3 months.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| model treatmentthe treatment decisions were decided by Machine Learning （ML） model in model treatment group | Other | model treatment |
| routine treatmentthe treatment decisions were decided by multi-disciplinary team （MDT） | Other | routine treatment |
Primary outcome
SREs（Skeletal related events）
Time frame: 1 year
occurance of SREs，including bone pain, pathological fractures, spinal cord compression, hypercalcemia, and the need for surgery or radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
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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?
A study testing model treatment and routine treatment in people with Lung Cancer and Bone Metastases, run by Shanghai 6th People's 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 4 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 12 Aug 2021. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SREs（Skeletal related events） (time frame: 1 year). 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 12 Aug 2021.