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

Unknown

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

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

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
Intervention / Treatment
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

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

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

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)

January 1, 2008

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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