CTC in Lung Caner Patients With Bone Metastases | NCT04568291

Studies
CTC in Lung Caner Patients With Bone Metastases

NCT04568291

Sponsor

Shanghai 6th People's Hospital

Status

Unknown status

Last Update Posted

Aug 12, 2021Actual

Enrollment

160Estimated

Phase

Not Applicable

Conditions

Lung Cancer
Bone Metastases
Single Cell Sequencing Technology

Interventions

model treatment
routine treatment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Mar 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Mar 6, 2020

First Submission Date that Met QC Criteria

Sep 23, 2020

First Posted Date

Sep 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2021

Last Update Posted Date

Aug 12, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhao Hui, Clinical Professor, Shanghai 6th People's HospitalPrincipal Investigator

Lead Sponsor

Shanghai 6th People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluate the feasibility of single cell sequencing technology based on three-dimensional bionic capture network;
To build a risk prediction model of bone related events based on single cell sequencing;
To verify the risk prediction model of bone related events by single cell sequencing;
To verify the comprehensive treatment of non-small cell lung cancer ( NSCLC) bone metastases.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
routine treatment	Active Comparator	routine treatment	Other: routine treatment
model treatment	Experimental	model treatment	Other: model treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
model treatment	Other	the treatment decisions were decided by Machine Learning （ML） model in model treatment group	model treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18-75 years
pathology-proven diagnosis of lung cancer and radiographical/pathological evidence of BM
no previous treatment for BM
good general condition (Eastern Cooperative Oncology Group, ECOG Performance scores: 0-2) with an estimated survival time > 3 months.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Sixth People'S Hospital	Recruiting	Shanghai	Other (Non U.s.)	200233	China

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided