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NCT04568291 Clinical Trial

CTC in Lung Caner Patients With Bone Metastases

Lung Cancer Clinical Trial

Official title:
Clinical Reasearch on Three Dimensional Bionic Capture Network Circulating Tumor Cell in Lung Caner Patients With Bone Metastases

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04568291
Other study ID # CTC01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date December 31, 2022

Study information
Verified date August 2021
Source Shanghai 6th People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. To verify the comprehensive treatment of non-small cell lung cancer ( NSCLC) bone metastases.

Recruitment information / eligibility
Status Recruiting
Enrollment 160
Est. completion date December 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. age 18-75 years 2. pathology-proven diagnosis of lung cancer and radiographical/pathological evidence of BM 3. no previous treatment for BM 4. good general condition (Eastern Cooperative Oncology Group, ECOG Performance scores: 0-2) with an estimated survival time > 3 months. Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• model treatment
the treatment decisions were decided by Machine Learning (ML) model in model treatment group
• routine treatment
the treatment decisions were decided by multi-disciplinary team (MDT)

Locations
Country Name City State
China Shanghai Sixth People'S Hospital Shanghai Other (Non U.s.)

Sponsors (1)
Lead Sponsor Collaborator
Shanghai 6th People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary SREs(Skeletal related events) occurance of SREs,including bone pain, pathological fractures, spinal cord compression, hypercalcemia, and the need for surgery or radiotherapy 1 year
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