NCT06801977

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Jan 2002Dec 2030

Study Start

First participant enrolled

January 1, 2002

Completed
23.1 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

23.5 years

First QC Date

January 24, 2025

Last Update Submit

January 24, 2025

Conditions

Keywords

Genome-Wide Association Studyprimary Pulmonary Lymphoepithelioma-like Carcinoma

Outcome Measures

Primary Outcomes (1)

  • the occurrence of Pulmonary Lymphoepithelioma-like Carcinoma

    pathological diagnosis of Pulmonary Lymphoepithelioma-like Carcinoma

    The enrollment of the participants

Study Arms (2)

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

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

Interventions

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

Foshan cohort, Guangdong, ChinaSYSUCC cohort, Guangdong, China

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • The subject is diagnosed with metastatic nasopharyngeal carcinoma; The subject has heavy cardiovascular, liver, or kidney disease.
  • Controls:
  • The subject is in good physical condition and has a stable level of consciousness;
  • The subject has prevalent cancer; The subject has heavy cardiovascular, liver, or kidney disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Foshan First People's Hospital

Foshan, Guangdong, 528000, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

Central Study Contacts

Tong-Min Wang, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 24, 2025

First Posted

January 30, 2025

Study Start

January 1, 2002

Primary Completion

June 30, 2025

Study Completion (Estimated)

December 31, 2030

Last Updated

January 30, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

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.

Locations