NCT03542253

Brief Summary

This experiment has now collected 50 cases, all through CT chest scans and blood exosome detection. Twenty-two patients underwent surgical treatment and 14 tissue specimens were examined for cancer and paracancerous tissue exosomesWe found that exosomal micor-A was highly expressed in early stage lung cancer tissues and was significantly higher than paracancerous tissues. The micor-A in the adjacent tissues was significantly higher than that in peripheral blood exosomes

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

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 18, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

May 20, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

May 18, 2018

Last Update Submit

May 18, 2018

Conditions

Keywords

Early lung cancer,ground-glass nodule,CT,exosome

Outcome Measures

Primary Outcomes (1)

  • exosome in cancer tissue and para cancerous tissue

    exosomal micor-A was highly expressed in early stage lung cancer tissues

    one year

Study Arms (17)

Age

Sex

triglyceride

Lipoprotein

CT

Target Reconstruction

micorRNA-A Plasma exocrine

micorRNA-A Paracancerous tiusse

pathologic diagnosis

Procedure: Surgery

hemolysis

ct-DNA

micorRNA-A in plasma

Sample quality control

positive

negative

micorRNA-R in plasma

micorRNA-R in Plasma exocrine

Surgery

Interventions

SurgeryPROCEDURE

After surgical treatment, pathological specimens were extracted to obtain pathological results

pathologic diagnosis

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From November 2017 to June 2019, there were nodules on the lungs, both men and women, and patients of the same age who had CT target reconstruction and miRNA and ctDNA detection at the same time had complete follow-up data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Combined diagnosis of CT and exosome in early lung cancer

Study Record Dates

First Submitted

May 18, 2018

First Posted

May 31, 2018

Study Start

May 20, 2018

Primary Completion

May 30, 2019

Study Completion

June 30, 2019

Last Updated

May 31, 2018

Record last verified: 2018-05