CTC in Lung Caner Patients With Bone Metastases

• Sponsor: Shanghai 6th People's Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04568291
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Bone Metastases; Single Cell Sequencing Technology	Other: model treatment; Other: routine treatment	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Reasearch on Three Dimensional Bionic Capture Network Circulating Tumor Cell in Lung Caner Patients With Bone Metastases
• Actual Study Start Date: Oct 1, 2020
• Anticipated Primary Completion Date: Mar 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: routine treatment routine treatment	Other: routine treatment; the treatment decisions were decided by multi-disciplinary team （MDT）
Experimental: model treatment model treatment	Other: model treatment; the treatment decisions were decided by Machine Learning （ML） model in model treatment group

Outcome Measures

Primary Outcome Measures

1. SREs（Skeletal related events） [1 year]

   occurance of SREs，including bone pain, pathological fractures, spinal cord compression, hypercalcemia, and the need for surgery or radiotherapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Sixth People'S Hospital	Shanghai	Other (Non U.s.)	China	200233

Sponsors and Collaborators

• Shanghai 6th People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhao Hui, Clinical Professor, Shanghai 6th People's Hospital
• ClinicalTrials.gov Identifier: NCT04568291
• Other Study ID Numbers: CTC01
• First Posted: Sep 29, 2020
• Last Update Posted: Aug 12, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases

Study Results

No Results Posted as of Aug 12, 2021