Evaluation of Predictive Visual Analog Scale (VAS) for De... | NCT02781532

Studies
Evaluation of Predictive Visual Analog Scale (VAS) for Determining the Ingesta of Patients Carrying a Digestive Cancer

NCT02781532

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

May 24, 2016Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Digestive System Neoplasms

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

May 2016

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

Apr 2014

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

May 20, 2016

First Submission Date that Met QC Criteria

May 23, 2016

First Posted Date

May 24, 2016Estimated

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

May 23, 2016

Last Update Posted Date

May 24, 2016Estimated

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

The main objective of our study is to determine if the evaluation of ingesta of cancer patients by VAS (on the day of hospitalization) is able to predict the actual ingesta of patients during hospitalization (for patients malnourished, at risk of malnutrition or risk free).

Detailed Description

Not provided

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

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of ingesta	Evaluation of ingesta will be done using SAV scale.	3 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged over 18 years
Admitted to hospital for systemic therapy of gastrointestinal cancer
Signature of the non-opposition.

Exclusion Criteria:

Patients who because of their affection will fasted more than 12:00 during the three days preceding hospitalization.
Artificial nutrition Patients

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

The study has been proposed to all patients with a gastrointestinal cancer hospitalized in our service.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nice		France		06000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004067	Digestive System Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided