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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Genetic: Genome-wide genotyping
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.
Genetic: Genome-wide genotyping
Whole blood from the participants was used to extract DNA for genotyping.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
First People's Hospital of Foshan

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2002

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SL-B2025-059-01

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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