NCT01958697

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 9, 2013

Status Verified

October 1, 2013

Enrollment Period

3 months

First QC Date

October 7, 2013

Last Update Submit

October 7, 2013

Conditions

Esophageal Cancer

Keywords

Nutritional DisordersFeeding Behavior

Outcome Measures

Primary Outcomes (1)

  • Overall 5 year survival

    Overall 5-year survival after esophagectomy for cancer

    5 years after esophagectomy

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Esophageal cancer patients recieving an esophagectomy

You may qualify if:

  • any type of esophagectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univresity Hospital Leuven - dept. Thoracic Surgery

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Esophageal NeoplasmsNutrition DisordersFeeding Behavior

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesNutritional and Metabolic DiseasesBehavior, AnimalBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Datamanager Thoracic Surgery

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 9, 2013

Study Start

July 1, 2013

Primary Completion

October 1, 2013

Study Completion

June 1, 2014

Last Updated

October 9, 2013

Record last verified: 2013-10

Locations

BE(1)