NCT05400304

Brief Summary

a multifactorial model combining radiomics with frozen section analysis is a potential biomarker for assessing Spread Through Air Space during surgery, which can provide decision-making support to therapeutic planning for early-stage lung adenocarcinomas.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

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

May 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2023

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

10 months

First QC Date

May 26, 2022

Last Update Submit

June 22, 2022

Conditions

Keywords

Spread Through Air Spaceradiomicsfrozen sectionPrediction Model

Outcome Measures

Primary Outcomes (2)

  • Sensitivity

    Testing the sensitivity of Radiomics to predict STAS using the area under receiver operating characteristic curve

    24 hour before operation

  • Specificity

    Testing the specificity of Radiomics to predict STAS using the area under receiver operating characteristic curve

    24 hour before operation

Study Arms (3)

Training dataset

No interventions

Diagnostic Test: radiomics

External validation1

No interventions

Diagnostic Test: radiomics

External validation2

No interventions

Diagnostic Test: radiomics

Interventions

radiomicsDIAGNOSTIC_TEST

The high-throughput extraction of large amounts of quantitative image features from medical images

External validation1External validation2Training dataset

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with pulmonary nodules in the collaborating institutes.

You may qualify if:

  • intraoperative frozen section diagnosis and final pathology diagnosis are available
  • preoperative standard non-enhanced CT is available
  • Pathologically confirmed

You may not qualify if:

  • with a previous history of radiation therapy, chemotherapy or biopsy
  • the time interval between the CT examination and surgery was more than two weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Radiomics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 1, 2022

Study Start

July 1, 2022

Primary Completion

May 1, 2023

Study Completion

May 12, 2023

Last Updated

June 29, 2022

Record last verified: 2022-06