Back to resultsCTC in Lung Caner Patients With Bone Metastases
Primary Purpose
Lung Cancer, Bone Metastases, Single Cell Sequencing Technology
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
model treatment
routine treatment
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
-
Sites / Locations
- Shanghai Sixth People'S HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
routine treatment
model treatment
Arm Description
routine treatment
model treatment
Outcomes
Primary Outcome Measures
SREs（Skeletal related events）
occurance of SREs，including bone pain, pathological fractures, spinal cord compression, hypercalcemia, and the need for surgery or radiotherapy
Secondary Outcome Measures
Full Information
NCT ID
NCT04568291
First Posted
March 6, 2020
Last Updated
August 9, 2021
Sponsor
Shanghai 6th People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04568291
Brief Title
CTC in Lung Caner Patients With Bone Metastases
Official Title
Clinical Reasearch on Three Dimensional Bionic Capture Network Circulating Tumor Cell in Lung Caner Patients With Bone Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 6th People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Bone Metastases, Single Cell Sequencing Technology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
routine treatment
Arm Type
Active Comparator
Arm Description
routine treatment
Arm Title
model treatment
Arm Type
Experimental
Arm Description
model treatment
Intervention Type
Other
Intervention Name(s)
model treatment
Intervention Description
the treatment decisions were decided by Machine Learning （ML） model in model treatment group
Intervention Type
Other
Intervention Name(s)
routine treatment
Intervention Description
the treatment decisions were decided by multi-disciplinary team （MDT）
Primary Outcome Measure Information:
Title
SREs（Skeletal related events）
Description
occurance of SREs，including bone pain, pathological fractures, spinal cord compression, hypercalcemia, and the need for surgery or radiotherapy
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
-
Facility Information:
Facility Name
Shanghai Sixth People'S Hospital
City
Shanghai
State/Province
Other (Non U.s.)
ZIP/Postal Code
200233
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hui zhao
Phone
13564460369
Email
areyouwangzhiyu@163.com
12. IPD Sharing Statement
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CTC in Lung Caner Patients With Bone Metastases
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