The MDA Test to Differentiate of Benign and Malignant Pulmonary Nodules

December 31, 2018 updated by: Tianjin Medical University Cancer Institute and Hospital

Targeted Chromosomal Aberrations Detection by FISH Analysis of Circulating Abnormal Cells to Differentiate of Benign and Malignant Pulmonary Nodules

  • 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  • Current state-of-the-art lung cancer early screening utilizes low-dose CT scan to identify lung nodules smaller than 3 cm in diameter. However, it's still a clinical challenge to differentiate between malignant and benign nodules.
  • This study is being conducted to evaluate the efficacy of the MDA TEST to detect Targeted chromosomal aberrations in circulating abnormal cells by FISH analysis that might be an early indicator of lung cancer. Approximately 200 Pre-surgery adult patients with single pulmonary nodule found by CT scan, will be enrolled in the study. The sample type of MDA test is Peripheral Blood. This study will compare the results of the pre-surgery MDA Test with the post-surgery pathology to determine if the test can detect lung cancer or the lack of lung cancer .
  • The results of the test will not be provided to the subject, the investigator and will not be used to diagnose or treat the subject.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

200 participants

Description

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diagnostic test
Targeted chromosomal aberrations detection by FISH (MDA TEST).
Diagnostic test: FISH
Targeted chromosomal aberrations detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early detection of lung cancer
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborators

Zhuhai livzon cynvenio diagnostics LTD

Investigators

  • Principal Investigator: Changli Wang, Prof, Tianjin Medical University Cancer Institute & Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2018

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

December 28, 2018

First Submitted That Met QC Criteria

December 31, 2018

First Posted (Actual)

January 2, 2019

Study Record Updates

Last Update Posted (Actual)

January 2, 2019

Last Update Submitted That Met QC Criteria

December 31, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TianjinCIH2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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