NCT02987777

Brief Summary

The aim of this study was to assess the frequency of PD-L1 expression in stage III-IV ECs and to investigate its correlation impact with progression-free survival (PFS), and clinicopathological features including microsatellite instability and quantified stromal and intraepithelial tumor-infiltrating CD8+ lymphocytes (TILs)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Status
completed

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, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
Last Updated

December 9, 2016

Status Verified

December 1, 2016

Enrollment Period

7 months

First QC Date

November 28, 2016

Last Update Submit

December 6, 2016

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    84 months

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients records would be extracted from the pathology database of the Lorraine Comprehensive Cancer Center, Nancy, France

You may qualify if:

  • All patients consecutively enrolled from January 2004 to December 2014 treated for Endometrial cancer
  • Stage III-IV endometrial cancer with available tissue blocks, including biopsies, hysterectomy specimens and resections of metastatic foci

You may not qualify if:

  • A patient record captured outside the time frame from January 2004 to December 2014

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2016

First Posted

December 9, 2016

Study Start

January 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

December 9, 2016

Record last verified: 2016-12