NCT04597814

Brief Summary

The serum levels of carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), CA125 are often increased in interstitial lung disease patients. This study was undertaken to investigate the source of these serum tumor markers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

1.8 years

First QC Date

October 16, 2020

Last Update Submit

October 22, 2020

Conditions

the Relationship Between the Tumor Markers and Interstitial Lung Disease Patients

Keywords

carcinoembryonic antigencarbohydrate antigen 19-9carbohydrate antigen 125

Outcome Measures

Primary Outcomes (9)

  • serum levels of carcinoembryonic antigen (CEA)

    serum levels of carcinoembryonic antigen (CEA)

    6months

  • serum levels of carbohydrate antigen 19-9 (CA19-9)

    serum levels of carbohydrate antigen 19-9 (CA19-9)

    6months

  • serum levels of carbohydrate antigen 125(CA125)

    serum levels of carbohydrate antigen 125(CA125)

    6months

  • The alveolar lavage fluid levels of carcinoembryonic antigen (CEA)

    The alveolar lavage fluid levels of carcinoembryonic antigen (CEA)

    1 week

  • The alveolar lavage fluid levels of carbohydrate antigen 19-9 (CA19-9)

    The alveolar lavage fluid levels of carbohydrate antigen 19-9 (CA19-9)

    1 week

  • The alveolar lavage fluid levels of carbohydrate antigen 125

    The alveolar lavage fluid levels of carbohydrate antigen 125

    1 week

  • The lung tissue levels of carcinoembryonic antigen (CEA)

    The lung tissue levels of carcinoembryonic antigen (CEA)

    1 week

  • The lung tissue levels of carbohydrate antigen 19-9 (CA19-9)

    The lung tissue levels of carbohydrate antigen 19-9 (CA19-9)

    1 week

  • The lung tissue levels of carbohydrate antigen 125

    The lung tissue levels of carbohydrate antigen 125

    1 week

Study Arms (2)

interstitial lung disease patients

interstitial lung disease patients who need lung transplantation

Other: No Intervention

non- interstitial lung disease patients

non- interstitial lung disease patients who need thoracic surgery to remove pneumatocele

Other: No Intervention

Interventions

No InterventionOTHER

No Intervention

interstitial lung disease patientsnon- interstitial lung disease patients

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

lung disease patients for lung transplantation

You may qualify if:

  • Interstitial lung disease patients for lung transplantation

You may not qualify if:

  • tumor
  • Interstitial lung disease patients could not be performed by lung transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 520120, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

lung specimen after lung transplantation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 16, 2020

First Posted

October 22, 2020

Study Start

January 1, 2019

Primary Completion

October 15, 2020

Study Completion

October 15, 2020

Last Updated

October 23, 2020

Record last verified: 2020-10

Locations

CN(1)