CTC in Lung Caner Patients With Bone Metastases

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Bone Metastases; Single Cell Sequencing Technology
• Intervention / Treatment: Other: routine treatment; Other: model treatment

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Other (Non U.s.)
    • Shanghai, Other (Non U.s.), China, 200233
      • Recruiting
      • Shanghai Sixth People's Hospital
      • Contact: hui zhao; Phone Number: 13564460369; Email: areyouwangzhiyu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai 6th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Hematologic Diseases; Musculoskeletal Diseases; Neoplastic Processes; Bone Diseases; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
• Other Study ID Numbers: CTC01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No