Construction and Evaluation of the Liquid Biopsy-based Ea... | NCT04156360

Studies
Construction and Evaluation of the Liquid Biopsy-based Early Diagnostic Model for Lung Cancer

NCT04156360

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Status

Unknown status

Last Update Posted

Nov 7, 2019Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Healthy
Pulmonary Nodule

Interventions

Not provided

Countries

Not provided

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

Nov 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2019Estimated

Primary Completion Date

Nov 1, 2020Estimated

Completion Date

Jun 1, 2021Estimated

First Submitted Date

Oct 28, 2019

First Submission Date that Met QC Criteria

Nov 5, 2019

First Posted Date

Nov 7, 2019Actual

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

Nov 5, 2019

Last Update Posted Date

Nov 7, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Caicun Zhou, Director Head of Medical Oncology, Shanghai Pulmonary Hospital, Shanghai, ChinaPrincipal Investigator

Lead Sponsor

Shanghai Pulmonary Hospital, Shanghai, ChinaOTHER

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

The purpose of this study is to detetct Circulating tumor cells(CTCs) and Cancer Associated Macrophage-Like cells (CAMLs) in patients with pulmonary nodules using a novel microfluidic CTC-detection system. Then construct an early diagnostic model for lung cancer.

Detailed Description

Patients found pulmonary nodules by CT screening will be enrolled in this study prospectively. CTCs and CAMLs both are cancer specific biomarkers found in the peripheral blood of patients with solid tumors including lung cancer. Through detecting CTCs and CAMLs in healthy volunteers and patients with pulmonary nodules who undergo biopsy, determine the cut-off value of the test. Further analysis of the test specificity and sensitivity, and on this basis construct an early diagnostic model for lung cancer.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determination of prevalence of CTCs and CAMLs in patients with pulmonary nodules	The number of CTCs and CAMLs will be detected in the peripheral blood of patients with pulmonary nodules using a novel microfluidic CTC-detection system.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Determination of optimal cut-off values for screening Lung Cancer paitents	The optimal cut-off values will be determined by the ROC analyses.	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female or male, 18 years of age or older
Pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans

Exclusion Criteria:

Prior diagnosis of lung cancer or other invasive malignancy within the past 5 years

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects with pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yayi He, MD, PHD	Contact	+862165115006		2250601@qq.com

Overall Officials

Name	Affiliation	Role
Yayi He, MD, PHD	Shanghai Pulmonary Hospital, Tongji University	Principal Investigator

Locations

Not provided