NCT03790735

Brief Summary

  • The purpose of the study is the identification of the efficacy of MDA Test to Differentiate of Benign and Malignant Pulmonary Nodules.
  • In this study, the investigators are going to validate the efficacy of the MDA test for diagnosing early lung cancer by comparing results of the pre-surgery MDA test with the post-surgery pathology.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 3, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 2, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 2, 2019

Status Verified

December 1, 2018

Enrollment Period

10 months

First QC Date

December 28, 2018

Last Update Submit

December 31, 2018

Conditions

Pulmonary Nodule, Solitary

Keywords

pulmonary nodule

Outcome Measures

Primary Outcomes (1)

  • Early detection of lung cancer

    The efficacy of the MDA TEST assay comparing with pathologic diagnosis(the gold standard), and CT/LDCT diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).

    6 months

Study Arms (1)

Diagnostic test

Targeted chromosomal aberrations detection by FISH (MDA TEST).

Diagnostic Test: FISH

Interventions

FISHDIAGNOSTIC_TEST

Targeted chromosomal aberrations detection

Diagnostic test

Eligibility Criteria

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

200 participants

You may qualify if:

  • years old or above
  • single pulmonary nodule found by CT scan.
  • the diameter of the pulmonary nodule is between 5mm to 30mm.
  • plan to accept pneumonectomy due to the pulmonary nodule.
  • agree to sign informed consent

You may not qualify if:

  • fail to understand or agree to sign informed consent.
  • pregnant or lactating women.
  • the diameter of the pulmonary nodule is more than 30mm.
  • there are 2 or more pulmonary nodules in one single patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Solitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Changli Wang, Prof

    Tianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongyan Cheng

CONTACT

(022)23340123-6012chengdongyan916@163.com

Study Design

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

Study Record Dates

First Submitted

December 28, 2018

First Posted

January 2, 2019

Study Start

May 3, 2018

Primary Completion

March 1, 2019

Study Completion

June 1, 2019

Last Updated

January 2, 2019

Record last verified: 2018-12

Locations

CN(1)