Age and Gender Corrected Body Mass Index | NCT01958697

Studies
Age and Gender Corrected Body Mass Index

NCT01958697

Sponsor

University Hospital, Gasthuisberg

Status

Unknown status

Last Update Posted

Oct 9, 2013Estimated

Enrollment

650Estimated

Phase

Not provided

Conditions

Esophageal Cancer

Interventions

Not provided

Countries

Belgium

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

Oct 2013

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

Jul 2013

Primary Completion Date

Oct 2013Estimated

Completion Date

Jun 2014Estimated

First Submitted Date

Oct 7, 2013

First Submission Date that Met QC Criteria

Oct 7, 2013

First Posted Date

Oct 9, 2013Estimated

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

Oct 7, 2013

Last Update Posted Date

Oct 9, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Johnny Moons, Datamanager Thoracic Surgery, University Hospital, GasthuisbergPrincipal Investigator

Lead Sponsor

University Hospital, GasthuisbergOTHER

Collaborators

Not provided

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

Esophagectomy for cancer is often accompanied with severe preoperative weight loss. Body Mass Index (BMI) values are age-independent and the same for both sexes. From the perspective that these two parameters should actually be taken into account too, we developed a model to calculate "age-gender specific BMI-percentiles" (AG-BMI) and tested this model in relation to survival outcome after esophagectomy for cancer.

Detailed Description

Age-Gender specific BMI percentiles are more accurate compared to the current BMI classes in predicting Overall Survival (OS) after esophagectomy for cancer. Furthermore we believe in a more devastating impact on OS from underweight and not from overweight.

By preoperatively identifying risk patients for poorer OS, especially the non-tumoral deaths, this can be a tool to tailor postoperative nutritional strategies to counter further weight loss and bringing postoperative weight to normal ranges.

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

650Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AG-BMI < 10 pct		Patients who's peroperative BMI is less than the 10th centile
AG-BMI >= 10th pct		Patients who's peroperative BMI equals or is greater than the 10th centile

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall 5 year survival	Overall 5-year survival after esophagectomy for cancer	5 years after esophagectomy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

any type of esophagectomy

Exclusion Criteria:

Preoperative organ metastasis (cM+ or yM+)
esophageal bypass surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Esophageal cancer patients recieving an esophagectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Univresity Hospital Leuven - dept. Thoracic Surgery		Leuven		3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal Neoplasms
D009748	Nutrition Disorders
D005247	Feeding Behavior

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided