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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04614818
Collaborator
(none)
700
1
168
4.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Non-intervention research

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

Study Type:
Observational
Anticipated Enrollment :
700 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Multi-center, Retrospective Analysis of Clinical Character, Outcome and Prognosis of Lymphoepithelioma-like Carcinoma
Actual Study Start Date :
Jan 1, 2008
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival [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.

Secondary Outcome Measures

  1. Overall survival [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
    1. Lymphoepithelioma-like carcinoma confirmed by histopathology;
    1. The primary lesion does not involve the nasopharynx;
    1. 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;
    1. Have a history of any other malignant tumors;
    1. Lack of complete data

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sun yat-sen University Cancer Center Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tongyu Lin, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT04614818
Other Study ID Numbers:
  • B2020-289-01
First Posted:
Nov 4, 2020
Last Update Posted:
Nov 4, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 4, 2020