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CTC in Lung Caner Patients With Bone Metastases

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ClinicalTrials.gov Identifier: NCT04568291
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : August 12, 2021
Sponsor:
Information provided by (Responsible Party):
Zhao Hui, Shanghai 6th People's Hospital

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 1, 2020
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. SREs（Skeletal related events） [ Time Frame: 1 year ]
    occurance of SREs，including bone pain, pathological fractures, spinal cord compression, hypercalcemia, and the need for surgery or radiotherapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568291


Locations
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China, Other (Non U.s.)
Shanghai Sixth People'S Hospital Recruiting
Shanghai, Other (Non U.s.), China, 200233
Contact: hui zhao    13564460369    areyouwangzhiyu@163.com   
Sponsors and Collaborators
Shanghai 6th People's Hospital
More Information
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Responsible Party: Zhao Hui, Clinical Professor, Shanghai 6th People's Hospital
ClinicalTrials.gov Identifier: NCT04568291    
Other Study ID Numbers: CTC01
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: August 12, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
 Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases