NCT04614818

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
12.8 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

13 years

First QC Date

October 26, 2020

Last Update Submit

November 3, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months.

Study Arms (9)

pulmonary lymphoepithelioma-like carcinoma

The primary site of lymphoepithelioma-like carcinoma locates in the lungs.

Other: Non-intervention research

lymphoepithelioma-like carcinoma of thymus

The primary site of lymphoepithelioma-like carcinoma locates in the thymus.

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.

Other: Non-intervention research

lymphoepithelioma-like carcinoma of stomach

The primary site of lymphoepithelioma-like carcinoma locates in the stomach.

Other: Non-intervention research

lymphoepithelioma-like carcinoma of esophagus

The primary site of lymphoepithelioma-like carcinoma locates in the esophagus.

Other: Non-intervention research

lymphoepithelioma-like carcinoma of liver

The primary site of lymphoepithelioma-like carcinoma locates in the liver.

Other: Non-intervention research

lymphoepithelioma-like carcinoma of ovaries

The primary site of lymphoepithelioma-like carcinoma locates in the ovaries.

Other: Non-intervention research

lymphoepithelioma-like carcinoma of cervix

The primary site of lymphoepithelioma-like carcinoma locates in the cervix.

Other: Non-intervention research

lymphoepithelioma-like carcinoma of tonsil

The primary site of lymphoepithelioma-like carcinoma locates in the tonsil.

Other: Non-intervention research

Interventions

Non-intervention research

lymphoepithelioma-like carcinoma of cervixlymphoepithelioma-like carcinoma of esophaguslymphoepithelioma-like carcinoma of liverlymphoepithelioma-like carcinoma of ovarieslymphoepithelioma-like carcinoma of salivary glandslymphoepithelioma-like carcinoma of stomachlymphoepithelioma-like carcinoma of thymuslymphoepithelioma-like carcinoma of tonsilpulmonary lymphoepithelioma-like carcinoma

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \. Lymphoepithelioma-like carcinoma confirmed by histopathology;
  • \. The primary lesion does not involve the nasopharynx;
  • \. Complete data for patient's character, laboratory and imaging test, treatment and follow-up are available.

You may not qualify if:

  • \. Concomitant with other tumor components at the time of diagnosis;
  • \. Have a history of any other malignant tumors;
  • \. Lack of complete data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 32703503BACKGROUND
  • Fang 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.

    PMID: 26361045BACKGROUND
  • He 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.

    PMID: 26793355BACKGROUND
  • Abouelfad 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.

    PMID: 28749097BACKGROUND
  • Chen 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.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 26, 2020

First Posted

November 4, 2020

Study Start

January 1, 2008

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations