HRCT in Prediction of Tumor Invasion in GGO Lung Adenocar... | NCT04165759

Studies
HRCT in Prediction of Tumor Invasion in GGO Lung Adenocarcinoma (ECTOP-1008)

NCT04165759

Sponsor

Fudan University

Status

Completed

Last Update Posted

Jul 21, 2023Actual

Enrollment

620Actual

Phase

Not provided

Conditions

Adenocarcinoma of Lung

Interventions

Not provided

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

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 18, 2019Actual

Primary Completion Date

Apr 30, 2021Actual

Completion Date

Jul 1, 2021Actual

First Submitted Date

Nov 14, 2019

First Submission Date that Met QC Criteria

Nov 14, 2019

First Posted Date

Nov 18, 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

Jul 19, 2023

Last Update Posted Date

Jul 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Haiquan Chen, Director of Department of thoracic surgery and multidisciplinary group of thoracic oncology, Fudan UniversityPrincipal Investigator

Lead Sponsor

Fudan UniversityOTHER

Collaborators

Name	Class
Fujian Medical University Union Hospital	OTHER
Shandong First Medical University Affiliated Liaocheng Second Hospital	UNKNOWN
Jiangdu People's Hospital, Yangzhou	UNKNOWN

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

This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1008). It aims to evaluate the correlation between radiological diagnosis based on HRCT and pathological invasiveness.Investigators observe the radiological features and the correlation with the postoperative pathological findings.

Detailed Description

Preoperative evaluation of pathologic tumor invasion of ground glass opacity (GGO) featured lung adenocarcinoma is important for selection of appropriate surgical extent. Whether thoracic high-resolution computed tomography (HRCT) scan could precisely predict pathologic tumor invasion remains unknown. Patients with peripheral GGO nodules (GGNs) would be enrolled, and HRCT with target scan would be performed preoperatively. Pathologic tumor invasion (invasive adenocarcinoma [IAD] versus adenocarcinoma in situ [AIS]/minimally invasive adenocarcinoma [MIA]) would be evaluated according to radiologic parameters of HRCT before surgery. Primary endpoint of this trial is the diagnostic sensitivity of pathologic tumor invasion evaluated by HRCT. Secondary endpoint is the diagnostic value of radiologic parameters of HRCT for pathologic tumor invasion of GGO featured lung adenocarcinoma.

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

Retention

Enrollment

620Actual

Label	Type	Description	Intervention Names
patients		Patients with lung cancer who are candidates for surgery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity	Diagnostic sensitivity of pathologic tumor invasion evaluated by HRCT	Pathologic reports were available, usually 1 month after surgery

Secondary Outcomes

Measure	Description	Time Frame
Value of radiologic parameters for tumor invasion	The receiver operating characteristic curve (ROC curve) and the area under the ROC curve (AUC) of the invasion prediction model based on radiologic parameters.	Pathologic reports were available, usually 1 month after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(1) GGNs on HRCT scan; (2) clinical stage IA; (3) simultaneously no more than three nodules; (5) Age ranging from 15 to 85 years.

Exclusion Criteria:

(1) pathologically confirmed non-adenocarcinoma; (2) patients who did not receive surgery.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

East Asian population

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Haiquan Chen	Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Cancer Center		Shanghai	Shanghai Municipality	200032	China
Fudan University Shanghai Cancer Center

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The IPD could be shared if a reasonable request was proposed.

Types

Study Protocol
Informed Consent Form (ICF)

Time Frame

The IPD could be shared if a reasonable request was proposed.

Access Criteria

An individual researcher could sent a mail to hqchen1@yahoo.com for these data.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000077192	Adenocarcinoma of Lung

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided