The Chinese Pulmonary Lymphoepithelioma-like Carcinoma Collaboration Study (CPLCC)

January 24, 2025 updated by: Jia wei-hua, Sun Yat-sen University

Genetic Susceptibility Study of Primary Pulmonary Lymphoepithelioma-like Carcinoma

This retrospective case-control study aims to investigate the genetic mechanisms of primary Pulmonary Lymphoepithelioma-like Carcinoma, identify genetic susceptibility loci associated with its onset, and explore potential pathogenic genes, providing new insights for its etiological research.

Study Overview

Detailed Description

Pulmonary lymphoepithelioma-like carcinoma (pLELC) is a rare non-small cell lung cancer (NSCLC) that histologically resembles nasopharyngeal carcinoma (NPC) and predominantly affects the Asian population. Epstein-Barr virus (EBV) infection is a recognized pathogenic factor, and the regional prevalence of pLELC suggests that genetic susceptibility also plays an important role. However, no genetic studies on pLELC have been conducted, leaving its genetic etiology poorly understood. In this study, genotyping for all the subjects was performed by using Illumina Infinium Global Screening Array. Genome-wide association followed by meta-analysis was performed for pLELC cases and healthy controls. The primary objective of this study is to discover susceptibility genes that explain the genetic mechanisms of pLELC.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Recruiting
        • Foshan First People's Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun yat-sen University Cancer Center
        • Contact:
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study population consisted of cases and controls with specific inclusion and exclusion criteria. Cases were individuals pathologically diagnosed with primary pulmonary lymphoepithelioma-like carcinoma (PLELC), excluding those with metastatic nasopharyngeal carcinoma or severe cardiovascular, liver, or kidney disease. Controls were individuals in good physical condition with stable levels of consciousness, excluding those with a history of cancer or severe cardiovascular, liver, or kidney disease.

Description

Case:

Inclusion criteria:

The subject is pathologically diagnosed with primary pulmonary lymphoepithelioma-like carcinoma.

Exclusion criteria:

The subject is diagnosed with metastatic nasopharyngeal carcinoma; The subject has heavy cardiovascular, liver, or kidney disease.

Controls:

Inclusion criteria:

The subject is in good physical condition and has a stable level of consciousness;

Exclusion criteria:

The subject has prevalent cancer; The subject has heavy cardiovascular, liver, or kidney disease.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SYSUCC cohort, Guangdong, China

Cases:

Patients aged 18 and above with a pathological diagnosis of primary pulmonary lymphoepithelioma-like carcinoma who were treated at the Sun Yat-sen University Cancer Center from January 1, 2002.

Controls:

Healthy participants aged 18 and above.

Whole blood from the participants was used to extract DNA for genotyping.
Foshan cohort, Guangdong, China

Cases:

Patients aged 18 and above with a pathological diagnosis of primary pulmonary lymphoepithelioma-like carcinoma who were treated at the the First People's Hospital of Foshan from January 1, 2007.

Controls:

Healthy participants aged 18 and above.

Whole blood from the participants was used to extract DNA for genotyping.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the occurrence of Pulmonary Lymphoepithelioma-like Carcinoma
Time Frame: The enrollment of the participants
pathological diagnosis of Pulmonary Lymphoepithelioma-like Carcinoma
The enrollment of the participants

Collaborators and Investigators

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

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)

January 1, 2002

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 24, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To prioritize participant confidentiality and privacy, we have decided not to release Individual Participant Data (IPD). This decision reflects our commitment to safeguarding the sensitive information of participants, in full compliance with ethical standards and privacy laws. It is taken to protect the well-being and privacy of all individuals involved in the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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