Prognostic PET/CT Model in Non Small Cell Lung Cancer | NCT03199599

Studies
Prognostic PET/CT Model in Non Small Cell Lung Cancer

NCT03199599

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Apr 13, 2020Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Non Small Cell Lung Cancer

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PRT-K15-119	Other Grant/Funding Number	INCA

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2016Actual

Primary Completion Date

Aug 31, 2019Actual

Completion Date

Aug 31, 2019Actual

First Submitted Date

Jun 23, 2017

First Submission Date that Met QC Criteria

Jun 26, 2017

First Posted Date

Jun 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2020

Last Update Posted Date

Apr 13, 2020Actual

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prospective validation of a prognostic model based on advanced PET/CT image analysis in non small cell lung cancer

Detailed Description

Validation on a prospective cohort of patient of a predictive model for survival based on image derived parameters

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
validation of a multiparametric PET/CT prognostic model	overall survival rate	18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

non small cell lung cancer
initial fluorodeoxygluoces (FDG) PET/CT before treatment

exclusion criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

150 patients with Non small cell lung cancer undergoing initial staging FDG PET/CT

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
MATHIEU HATT, PhD	Institut National de la Santé Et de la Recherche Médicale, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Poitiers		Poitiers			France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided