PREMIUM, Observational Study | NCT01756625

Studies
PREMIUM, Observational Study

NCT01756625

Sponsor

Dr.Laurent Mineur

Status

Unknown status

Last Update Posted

Dec 27, 2012Estimated

Enrollment

500Actual

Phase

Not provided

Conditions

First Line WT KRAS mCRC

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

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Mar 2012Actual

Completion Date

Jun 2013Estimated

First Submitted Date

Dec 20, 2012

First Submission Date that Met QC Criteria

Dec 20, 2012

First Posted Date

Dec 27, 2012Estimated

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

Dec 20, 2012

Last Update Posted Date

Dec 27, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr.Laurent Mineur, Oncologist, Institut Sainte CatherineSponsor-Investigator

Lead Sponsor

Dr.Laurent MineurOTHER

Collaborators

Name	Class
Merck Serono International SA	INDUSTRY
BESPIM, CHU Nîmes (data analysis)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

PREMIUM is an observational pharmaco-epidemiologic, transversal, multi-centric, prospective cohort study and with independent investigators. The purpose is to compare PFS in real life with PFS clinical trials and to determine factors impacting efficacy and compliance to cetuximab treatment in first line K-ras wild-type (wt) metastatic colorectal cancer.

Detailed Description

Retrospective studies have shown the influence of some factors on the efficacy of treatment with cetuximab (nicotine, magnesium etc..). No randomized study has compared the mode of administration of weekly and biweekly cetuximab. What are the factors influencing patient compliance? Adverse events, the relation between doctor and patient. PREMIUM will attempt to explore and assess the variables associated with efficacy and compliance to treatment and study practices in France for clinical management.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

500Actual

Label	Type	Description	Intervention Names
First line WT KRAS mCRC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare PFS rate at 1 year with PFS in clinical studies (ITT and subgroup analysis)		3 years

Secondary Outcomes

Measure	Description	Time Frame
ORR at 1 year (ITT and subgroup analysis)		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients > 18 years old diagnosed with mCRC
patients naïve for CT excepted for adjuvant setting or trated max 2 cycles CT in first line mCRC with or without cetuximab
all patients receiving cetuximab in first line treatment associated or not with CT
patients relapsed < 6 months after an adjuvant therapy

Exclusion Criteria:

patients participating to clinical trials

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

patients from private and public centers

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Sainte-Catherine		Avignon	Vaucluse	84000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33347495	Derived	Mineur L, Francois E, Plassot C, Phelip JM, Miglianico L, Dourthe LM, Bonichon N, Moreau L, Guimbaud R, Smith D, Achille E, Herve R, Bons JM, Remy S, Faroux R, Villing AL, Mahamat A, Rabbia I, Soulie P, Baumgaertner I, Mathe N, Vazquez L, Boustany R. PREMIUM: A French prospective multicenter observational study of factors impacting on efficacy and compliance to cetuximab treatment in first-line KRAS wild-type metastatic colorectal cancer. PLoS One. 2020 Dec 21;15(12):e0243997. doi: 10.1371/journal.pone.0243997. eCollection 2020.