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
• Status: Recruiting
• Phase: N/A
• 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
• 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:

-

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Lung Cancer
• Neoplasm Metastasis
• Single Cell Sequencing Technology

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