NCT04568291

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

March 6, 2020

Last Update Submit

August 9, 2021

Conditions

Lung CancerBone MetastasesSingle Cell Sequencing Technology

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

routine treatment

ACTIVE COMPARATOR

routine treatment

Other: routine treatment

model treatment

EXPERIMENTAL

model treatment

Other: model treatment

Interventions

model treatmentOTHER

the treatment decisions were decided by Machine Learning （ML） model in model treatment group

model treatment
routine treatmentOTHER

the treatment decisions were decided by multi-disciplinary team （MDT）

routine treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Sixth People'S Hospital

Shanghai, Other (Non U.s.), 200233, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 6, 2020

First Posted

September 29, 2020

Study Start

October 1, 2020

Primary Completion

March 31, 2022

Study Completion

December 31, 2022

Last Updated

August 12, 2021

Record last verified: 2021-08

Locations

CN(1)