Primary Pulmonary Lymphoepithelioma-like CarcinomaCPLCCNCT06801977
The Chinese Pulmonary Lymphoepithelioma-like Carcinoma Collaboration Study
An observational study of Primary Pulmonary Lymphoepithelioma-like Carcinoma, run by Sun Yat-sen University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Pulmonary Lymphoepithelioma-like Carcinoma
- What is being tested?
- Genome-wide genotyping
- How many people
- 10,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2002to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- The subject is pathologically diagnosed with primary pulmonary lymphoepithelioma-like carcinoma.
- The subject is in good physical condition and has a stable level of consciousness;
Who cannot join
- The subject is diagnosed with metastatic nasopharyngeal carcinoma; The subject has heavy cardiovascular, liver, or kidney disease.
- Controls:
- The subject has prevalent cancer; The subject has heavy cardiovascular, liver, or kidney disease.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Foshan First People's Hospital
Foshan, Guangdong, 528000
Liu Fang, 86+18038860223, gyliuf@126.com
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Jia Wei-Hua, 86+020-87342327, jiawh@sysucc.org.cn
He Yong-Qiao, 86+020-87342410, heyq@sysucc.org.cn
About this study
Official title: 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.
Read the 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.
- Being tested
- Genome-wide genotyping
- Keywords
- Genome-Wide Association Study, primary Pulmonary Lymphoepithelioma-like Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genome-wide genotypingGenetic
Whole blood from the participants was used to extract DNA for genotyping.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Genetic: Genome-wide genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
the occurrence of Pulmonary Lymphoepithelioma-like Carcinoma
pathological diagnosis of Pulmonary Lymphoepithelioma-like Carcinoma
Measured: The enrollment of the participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Jan 2002
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Pulmonary Lymphoepithelioma-like CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First People's Hospital of Foshan
- Responsible party
- Principal investigator, Jia wei-hua, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801977
- Sponsor's protocol ID
- SL-B2025-059-01
- Acronym
- CPLCC
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Susceptibility Study of Primary Pulmonary Lymphoepithelioma-like Carcinoma
- ClinicalTrials.gov ID
- NCT06801977
- Acronym / sponsor ID
- CPLCC / SL-B2025-059-01
- Keywords
- Genome-Wide Association Study, primary Pulmonary Lymphoepithelioma-like Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First People's Hospital of Foshan
- Study start
- 1 Jan 2002 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYSUCC cohort, Guangdong, China | – | Genetic: Genome-wide genotypingCases: 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. |
| Foshan cohort, Guangdong, China | – | Genetic: Genome-wide genotypingCases: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- The subject is pathologically diagnosed with primary pulmonary lymphoepithelioma-like carcinoma.
- The subject is in good physical condition and has a stable level of consciousness;
Key exclusion criteria (3 listed)
- The subject is diagnosed with metastatic nasopharyngeal carcinoma; The subject has heavy cardiovascular, liver, or kidney disease.
- The subject has prevalent cancer; The subject has heavy cardiovascular, liver, or kidney disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genome-wide genotypingWhole blood from the participants was used to extract DNA for genotyping. | Genetic | Foshan cohort, Guangdong, China, SYSUCC cohort, Guangdong, China |
Primary outcome
the occurrence of Pulmonary Lymphoepithelioma-like Carcinoma
Time frame: The enrollment of the participants
pathological diagnosis of Pulmonary Lymphoepithelioma-like Carcinoma
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Pulmonary Lymphoepithelioma-like Carcinoma, run by Sun Yat-sen University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei-Hua Jia, MD (86+020-87342327, jiawh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the occurrence of Pulmonary Lymphoepithelioma-like Carcinoma (time frame: The enrollment of the participants). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.