NCT04309422

Brief Summary

Search correlation between texture features in CT-PET 18 FDG and overexpression of PDL1 in non-small cell lung carcinomas during the inital staging. The hypothesis is that overexpression of PDL1is correlated with at least one texture feature among those selected. 84 CT-PET 18 FDG at the initial staging of a non small cell lung carcinoma (adenocarcinoma or squamous cell carcinoma), whose the biopsed site was the primitive site or the drainage lymphadenopathy, without previous treatment, were recruited and analyzed by a software allowing to estimate texture features.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

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

April 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

March 12, 2020

Last Update Submit

March 16, 2020

Conditions

Keywords

Correlation between overexpression of PDL1texture featuresCT-PET 18 FDGNon Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Correlation between at least one texture feature and overexpression of PDL1

    Correlation between at least one texture feature and overexpression of PDL1

    1 day

Study Arms (2)

Overexpression of PDL1

Overexpression of PDL1

Absence of overexpression of PDL1

Absence of overexpression of PDL1

Eligibility Criteria

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

Adult patient with initial CT-PET 18 FDG realized in the nuclear service of Montpellier university hospital, with non small cell lung carcinoma diagnosed with biopsy of the primitive site or local drainage lymphadenopathy.

You may qualify if:

  • adult patient ;
  • first CT-PET 18 FDG realized for the inital staging ;
  • absence of previous treatment for a thoracic neoplasm ;
  • biopsy realized on the primitive site or local drainage lymphadenopathy ;
  • primitive site viewable with morphological imagery ;
  • availability of evaluation of PDL1's overexpression ;

You may not qualify if:

  • \- Refusal to participate in this research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jean-Baptiste MALLET

    University Hospitals of Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 12, 2020

First Posted

March 16, 2020

Study Start

April 1, 2018

Primary Completion

October 1, 2018

Study Completion

January 31, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations