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Construction and Evaluation of the Liquid Biopsy-based Early Diagnostic Model for Lung Cancer

NCT ID: NCT04156360

Last Updated: 2019-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-06-01

Brief Summary

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The purpose of this study is to detetct Circulating tumor cells(CTCs) and Cancer Associated Macrophage-Like cells (CAMLs) in patients with pulmonary nodules using a novel microfluidic CTC-detection system. Then construct an early diagnostic model for lung cancer.

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Detailed Description

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Patients found pulmonary nodules by CT screening will be enrolled in this study prospectively. CTCs and CAMLs both are cancer specific biomarkers found in the peripheral blood of patients with solid tumors including lung cancer. Through detecting CTCs and CAMLs in healthy volunteers and patients with pulmonary nodules who undergo biopsy, determine the cut-off value of the test. Further analysis of the test specificity and sensitivity, and on this basis construct an early diagnostic model for lung cancer.

Conditions

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Healthy Pulmonary Nodule

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Volunteers

No interventions assigned to this group

Patients With Pulmonary Nodule

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Female or male, 18 years of age or older
* Pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans

Exclusion Criteria

* Prior diagnosis of lung cancer or other invasive malignancy within the past 5 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role lead

Responsible Party

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Caicun Zhou

Director Head of Medical Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yayi He, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Tongji University

Central Contacts

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Yayi He, MD, PHD

Role: CONTACT

[email protected]
+862165115006

Other Identifiers

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YT2019-001

Identifier Type: -

Identifier Source: org_study_id

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