A Multi-center, Retrospective Analysis of Clinical Character, Outcome and Prognosis of Lymphoepithelioma-like Carcinoma

November 3, 2020 updated by: Tongyu Lin, Sun Yat-sen University
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.

Study Overview

Status

Status

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

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

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 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 (Anticipated)

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.
700

Contacts and Locations

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

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

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.
pulmonary lymphoepithelioma-like carcinoma
The primary site of lymphoepithelioma-like carcinoma locates in the lungs.
Other: Non-intervention research
Non-intervention research
lymphoepithelioma-like carcinoma of thymus
The primary site of lymphoepithelioma-like carcinoma locates in the thymus.
Other: Non-intervention research
Non-intervention research
lymphoepithelioma-like carcinoma of salivary glands
The primary site of lymphoepithelioma-like carcinoma locates in the parotid gland or submandibular gland.
Other: Non-intervention research
Non-intervention research
lymphoepithelioma-like carcinoma of stomach
The primary site of lymphoepithelioma-like carcinoma locates in the stomach.
Other: Non-intervention research
Non-intervention research
lymphoepithelioma-like carcinoma of esophagus
The primary site of lymphoepithelioma-like carcinoma locates in the esophagus.
Other: Non-intervention research
Non-intervention research
lymphoepithelioma-like carcinoma of liver
The primary site of lymphoepithelioma-like carcinoma locates in the liver.
Other: Non-intervention research
Non-intervention research
lymphoepithelioma-like carcinoma of ovaries
The primary site of lymphoepithelioma-like carcinoma locates in the ovaries.
Other: Non-intervention research
Non-intervention research
lymphoepithelioma-like carcinoma of cervix
The primary site of lymphoepithelioma-like carcinoma locates in the cervix.
Other: Non-intervention research
Non-intervention research
lymphoepithelioma-like carcinoma of tonsil
The primary site of lymphoepithelioma-like carcinoma locates in the tonsil.
Other: Non-intervention research
Non-intervention research

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
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months.
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.
From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2008

Primary Completion (Anticipated)

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.
December 31, 2020

Study Completion (Anticipated)

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, 2021

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).
October 26, 2020

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.
November 3, 2020

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.
November 4, 2020

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.
November 4, 2020

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.
November 3, 2020

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.
November 1, 2020

More Information

Terms related to this study

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.
  • B2020-289-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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