NCT04165759

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
620

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

2 active sites

Status
completed

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

November 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

November 18, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

November 14, 2019

Last Update Submit

July 19, 2023

Conditions

Adenocarcinoma of Lung

Outcome Measures

Primary Outcomes (1)

  • Sensitivity

    Diagnostic sensitivity of pathologic tumor invasion evaluated by HRCT

    Pathologic reports were available, usually 1 month after surgery

Secondary Outcomes (1)

  • Value of radiologic parameters for tumor invasion

    Pathologic reports were available, usually 1 month after surgery

Study Arms (1)

patients

Patients with lung cancer who are candidates for surgery.

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

East Asian population

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Lung surgical specimens

MeSH Terms

Conditions

Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by Site

Study Officials

  • Haiquan Chen

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of thoracic surgery and multidisciplinary group of thoracic oncology

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 18, 2019

Study Start

November 18, 2019

Primary Completion

April 30, 2021

Study Completion

July 1, 2021

Last Updated

July 21, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, 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.

Locations

CN(2)