Lymphoepithelioma-Like CarcinomaNCT04614818
A Multi-center, Retrospective Analysis of Clinical Character, Outcome and Prognosis of Lymphoepithelioma-like Carcinoma
An observational study of Lymphoepithelioma-Like Carcinoma and Lymphoepithelioma-Like Carcinoma of Thymus, run by Sun Yat-sen University at 1 site in China.
Trial summary
The investigators retrospective collect the clinical data of patients diagnosed with lymphoepithelioma-like carcinoma, including primary site, gender, age, smoking history, tumor stage, time of initial treatment, EBV-DNA copy number, first-line treatment and survival status. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoepithelioma-Like Carcinoma, Lymphoepithelioma-Like Carcinoma of Thymus, Lung Cancer
- What is being tested?
- Non-intervention research
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2008to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with confirmed diagnosis of lymphoepithelioma-like carcinoma of any primary site, including lung, salivary glands, thymus, tonsil, liver, stomach, esophagus, ovary, cervix et al.
Who may be able to join
- 1. Lymphoepithelioma-like carcinoma confirmed by histopathology;
- 2. The primary lesion does not involve the nasopharynx;
- 3. Complete data for patient's character, laboratory and imaging test, treatment and follow-up are available.
Who cannot join
- 1. Concomitant with other tumor components at the time of diagnosis;
- 2. Have a history of any other malignant tumors;
- 3. Lack of complete data
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Mei-ting Chen, Doctor, chenmt@sysucc.org.cn
About this study
The investigators retrospective collect the clinical data of patients diagnosed with lymphoepithelioma-like carcinoma, including primary site, gender, age, smoking history, tumor stage, time of initial treatment, EBV-DNA copy number, first-line treatment and survival status.
Read the detailed description
Lymphoepithelioma-like carcinoma (LELC) is a rare EBV-related tumor. Its histology is similar to that of nasopharyngeal carcinoma. In 2004, the WHO classified LELC into one subtype of large cell carcinoma, and the 2015 WHO classified it as other and unclassified cancers. LELC can originate in many organs, including parotid glands, throat, lungs, digestive tract, genitourinary system, etc. Driver gene mutations are rarely seen, and most of them are PD-L1 positive. In terms of treatment, there is no standard first-line treatment for lymphoepithelioma-like cancer. Patients with early-stage lymphoepithelioma-like cancer can receive surgery or radiotherapy, while palliative radiotherapy or chemotherapy is the main treatment for patients in advanced stage. The survival time is about 107 months, the 5-year OS is 59.5%, which is better than the prognosis of lung squamous cell carcinoma in the same period. A retrospective study of Sun yat-sen University Cancer Hospital included 127 patients with advanced lung LELC who received first-line chemotherapy between 2007 and 2018. Gemcitabine and platinum based chemotherapy and paclitaxel and platinum based regimens are significantly better than pemetrexed and platinum, but most of the current studies on lymphoepithelioma-like cancer focus on LELC that originates in the lung. But for other sites, such as parotid glands, liver, digestive tract, are mostly based on case reports, and there are few retrospective studies with large samples to explore their clinical features and treatment outcome. Therefore, investigators designed this retrospective clinical study to analyze the clinical characteristics, treatment, survival, and prognostic risk factors of patients with lymphoepithelioma-like carcinoma in order to summary the clinical character and guide treatment.
- Being tested
- Non-intervention research
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-intervention researchOther
Non-intervention research
| Study group | Role | What they receive |
|---|---|---|
| pulmonary lymphoepithelioma-like carcinoma | The primary site of lymphoepithelioma-like carcinoma locates in the lungs. Receives: Other: Non-intervention research | |
| lymphoepithelioma-like carcinoma of thymus | The primary site of lymphoepithelioma-like carcinoma locates in the thymus. Receives: Other: Non-intervention research | |
| lymphoepithelioma-like carcinoma of salivary glands | The primary site of lymphoepithelioma-like carcinoma locates in the parotid gland or submandibular gland. Receives: Other: Non-intervention research | |
| lymphoepithelioma-like carcinoma of stomach | The primary site of lymphoepithelioma-like carcinoma locates in the stomach. Receives: Other: Non-intervention research | |
| lymphoepithelioma-like carcinoma of esophagus | The primary site of lymphoepithelioma-like carcinoma locates in the esophagus. Receives: Other: Non-intervention research | |
| lymphoepithelioma-like carcinoma of liver | The primary site of lymphoepithelioma-like carcinoma locates in the liver. Receives: Other: Non-intervention research | |
| lymphoepithelioma-like carcinoma of ovaries | The primary site of lymphoepithelioma-like carcinoma locates in the ovaries. Receives: Other: Non-intervention research | |
| lymphoepithelioma-like carcinoma of cervix | The primary site of lymphoepithelioma-like carcinoma locates in the cervix. Receives: Other: Non-intervention research | |
| lymphoepithelioma-like carcinoma of tonsil | The primary site of lymphoepithelioma-like carcinoma locates in the tonsil. Receives: Other: Non-intervention research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Measured: From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
Secondary outcomes (1)
Overall survival
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
Measured: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Jan 2008
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tongyu Lin, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614818
- Sponsor's protocol ID
- B2020-289-01
- Status last verified
- Nov 2020
- First submitted
- 26 Oct 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu Q, Wang W, Zhou P, Fu Y, Zhang Y, Shao YW, Jiang L. Primary pulmonary lymphoepithelioma-like carcinoma is characterized by high PD-L1 expression, but low tumor mutation burden. Pathol Res Pract. 2020 Aug;216(8):153043. doi: 10.1016/j.prp.2020.153043. Epub 2020 Jun 2.
PubMed 32703503Fang W, Hong S, Chen N, He X, Zhan J, Qin T, Zhou T, Hu Z, Ma Y, Zhao Y, Tian Y, Yang Y, Xue C, Tang Y, Huang Y, Zhao H, Zhang L. PD-L1 is remarkably over-expressed in EBV-associated pulmonary lymphoepithelioma-like carcinoma and related to poor disease-free survival. Oncotarget. 2015 Oct 20;6(32):33019-32. doi: 10.18632/oncotarget.5028.
PubMed 26361045He J, Shen J, Pan H, Huang J, Liang W, He J. Pulmonary lymphoepithelioma-like carcinoma: a Surveillance, Epidemiology, and End Results database analysis. J Thorac Dis. 2015 Dec;7(12):2330-8. doi: 10.3978/j.issn.2072-1439.2015.12.62.
PubMed 26793355Abouelfad DM, Yassen NN, Amin HAA, Shabana ME. Lymphoepithelioma-Like Carcinoma of the Breast Mimicking Granulomatous Mastitis- Case Report and Review of the Literature. Asian Pac J Cancer Prev. 2017 Jul 27;18(7):1737-1741. doi: 10.22034/APJCP.2017.18.7.1737.
PubMed 28749097Chen M, Chen Y, Fang X, Wang Z, Pu X, Liang C, Guo H, Li Q, Pan F, Hong H, Huang H, Li J, Lin T. Clinical features and treatment outcome of lymphoepithelioma-like carcinoma from multiple primary sites: a population-based, multicentre, real-world study. BMC Pulm Med. 2022 Sep 22;22(1):360. doi: 10.1186/s12890-022-02097-6.
PubMed 36138362
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Retrospective Analysis of Clinical Character, Outcome and Prognosis of Lymphoepithelioma-like Carcinoma
- ClinicalTrials.gov ID
- NCT04614818
- Acronym / sponsor ID
- B2020-289-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 4 Nov 2020 (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.
The investigators retrospective collect the clinical data of patients diagnosed with lymphoepithelioma-like carcinoma, including primary site, gender, age, smoking history, tumor stage, time of initial treatment, EBV-DNA copy number, first-line treatment and survival status.
Detailed description
Lymphoepithelioma-like carcinoma (LELC) is a rare EBV-related tumor. Its histology is similar to that of nasopharyngeal carcinoma. In 2004, the WHO classified LELC into one subtype of large cell carcinoma, and the 2015 WHO classified it as other and unclassified cancers. LELC can originate in many organs, including parotid glands, throat, lungs, digestive tract, genitourinary system, etc. Driver gene mutations are rarely seen, and most of them are PD-L1 positive. In terms of treatment, there is no standard first-line treatment for lymphoepithelioma-like cancer. Patients with early-stage lymphoepithelioma-like cancer can receive surgery or radiotherapy, while palliative radiotherapy or chemotherapy is the main treatment for patients in advanced stage. The survival time is about 107 months, the 5-year OS is 59.5%, which is better than the prognosis of lung squamous cell carcinoma in the same period. A retrospective study of Sun yat-sen University Cancer Hospital included 127 patients with advanced lung LELC who received first-line chemotherapy between 2007 and 2018. Gemcitabine and platinum based chemotherapy and paclitaxel and platinum based regimens are significantly better than pemetrexed and platinum, but most of the current studies on lymphoepithelioma-like cancer focus on LELC that originates in the lung. But for other sites, such as parotid glands, liver, digestive tract, are mostly based on case reports, and there are few retrospective studies with large samples to explore their clinical features and treatment outcome. Therefore, investigators designed this retrospective clinical study to analyze the clinical characteristics, treatment, survival, and prognostic risk factors of patients with lymphoepithelioma-like carcinoma in order to summary the clinical character and guide treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| pulmonary lymphoepithelioma-like carcinoma | – | Other: Non-intervention researchThe primary site of lymphoepithelioma-like carcinoma locates in the lungs. |
| lymphoepithelioma-like carcinoma of thymus | – | Other: Non-intervention researchThe primary site of lymphoepithelioma-like carcinoma locates in the thymus. |
| lymphoepithelioma-like carcinoma of salivary glands | – | Other: Non-intervention researchThe primary site of lymphoepithelioma-like carcinoma locates in the parotid gland or submandibular gland. |
| lymphoepithelioma-like carcinoma of stomach | – | Other: Non-intervention researchThe primary site of lymphoepithelioma-like carcinoma locates in the stomach. |
| lymphoepithelioma-like carcinoma of esophagus | – | Other: Non-intervention researchThe primary site of lymphoepithelioma-like carcinoma locates in the esophagus. |
| lymphoepithelioma-like carcinoma of liver | – | Other: Non-intervention researchThe primary site of lymphoepithelioma-like carcinoma locates in the liver. |
| lymphoepithelioma-like carcinoma of ovaries | – | Other: Non-intervention researchThe primary site of lymphoepithelioma-like carcinoma locates in the ovaries. |
| lymphoepithelioma-like carcinoma of cervix | – | Other: Non-intervention researchThe primary site of lymphoepithelioma-like carcinoma locates in the cervix. |
| lymphoepithelioma-like carcinoma of tonsil | – | Other: Non-intervention researchThe primary site of lymphoepithelioma-like carcinoma locates in the tonsil. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with confirmed diagnosis of lymphoepithelioma-like carcinoma of any primary site, including lung, salivary glands, thymus, tonsil, liver, stomach, esophagus, ovary, cervix et al.
Key inclusion criteria (3 listed)
- 1. Lymphoepithelioma-like carcinoma confirmed by histopathology;
- 2. The primary lesion does not involve the nasopharynx;
- 3. Complete data for patient's character, laboratory and imaging test, treatment and follow-up are available.
Key exclusion criteria (3 listed)
- 1. Concomitant with other tumor components at the time of diagnosis;
- 2. Have a history of any other malignant tumors;
- 3. Lack of complete data
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 |
|---|---|---|
| Non-intervention researchNon-intervention research | Other | lymphoepithelioma-like carcinoma of cervix, lymphoepithelioma-like carcinoma of esophagus, lymphoepithelioma-like carcinoma of liver, lymphoepithelioma-like carcinoma of ovaries, lymphoepithelioma-like carcinoma of salivary glands, lymphoepithelioma-like carcinoma of stomach, lymphoepithelioma-like carcinoma of thymus, lymphoepithelioma-like carcinoma of tonsil, pulmonary lymphoepithelioma-like carcinoma |
Primary outcome
Progression-free survival
Time frame: From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
1 secondary outcome
Overall survival
Time frame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 32703503Wu Q, Wang W, Zhou P, Fu Y, Zhang Y, Shao YW, Jiang L. Primary pulmonary lymphoepithelioma-like carcinoma is characterized by high PD-L1 expression, but low tumor mutation burden. Pathol Res Pract. 2020 Aug;216(8):153043. doi: 10.1016/j.prp.2020.153043. Epub 2020 Jun 2.
- Background: PubMed 26361045Fang W, Hong S, Chen N, He X, Zhan J, Qin T, Zhou T, Hu Z, Ma Y, Zhao Y, Tian Y, Yang Y, Xue C, Tang Y, Huang Y, Zhao H, Zhang L. PD-L1 is remarkably over-expressed in EBV-associated pulmonary lymphoepithelioma-like carcinoma and related to poor disease-free survival. Oncotarget. 2015 Oct 20;6(32):33019-32. doi: 10.18632/oncotarget.5028.
- Background: PubMed 26793355He J, Shen J, Pan H, Huang J, Liang W, He J. Pulmonary lymphoepithelioma-like carcinoma: a Surveillance, Epidemiology, and End Results database analysis. J Thorac Dis. 2015 Dec;7(12):2330-8. doi: 10.3978/j.issn.2072-1439.2015.12.62.
- Background: PubMed 28749097Abouelfad DM, Yassen NN, Amin HAA, Shabana ME. Lymphoepithelioma-Like Carcinoma of the Breast Mimicking Granulomatous Mastitis- Case Report and Review of the Literature. Asian Pac J Cancer Prev. 2017 Jul 27;18(7):1737-1741. doi: 10.22034/APJCP.2017.18.7.1737.
- Derived from this study: PubMed 36138362Chen M, Chen Y, Fang X, Wang Z, Pu X, Liang C, Guo H, Li Q, Pan F, Hong H, Huang H, Li J, Lin T. Clinical features and treatment outcome of lymphoepithelioma-like carcinoma from multiple primary sites: a population-based, multicentre, real-world study. BMC Pulm Med. 2022 Sep 22;22(1):360. doi: 10.1186/s12890-022-02097-6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoepithelioma-Like Carcinoma and Lymphoepithelioma-Like Carcinoma of Thymus, run by Sun Yat-sen University at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04614818, which also lists 5 linked publications.
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 4 Nov 2020; AzTrials last refreshed its copy on 7 Nov 2026.