Esophageal CancerNCT01958697
Age and Gender Corrected Body Mass Index
An observational study of Esophageal Cancer, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Esophageal Cancer
- How many people
- 650 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Esophageal cancer patients recieving an esophagectomy
Who may be able to join
- any type of esophagectomy
Who cannot join
- Preoperative organ metastasis (cM+ or yM+)
- esophageal bypass surgery
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Univresity Hospital Leuven - dept. Thoracic Surgery
Leuven, 3000
About this study
Official title: Age and Gender Corrected Body Mass Index: When Preoperative Weight Loss and Underweight Are Becomming Clinically Significant in Esophagectomy for Cancer.
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.
Read the 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.
- Conditions
- Esophageal Cancer
- Keywords
- Nutritional Disorders, Feeding Behavior
- Medical subject headings
- Esophageal Neoplasms, Nutrition Disorders, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall 5 year survival
Overall 5-year survival after esophagectomy for cancer
Measured: 5 years after esophagectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnny Moons, University Hospital, Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958697
- Sponsor's protocol ID
- AG-BMI
- Status last verified
- Oct 2013
- First submitted
- 7 Oct 2013
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age and Gender Corrected Body Mass Index: When Preoperative Weight Loss and Underweight Are Becomming Clinically Significant in Esophagectomy for Cancer.
- ClinicalTrials.gov ID
- NCT01958697
- Acronym / sponsor ID
- AG-BMI
- Conditions
- Esophageal Cancer
- Keywords
- Nutritional Disorders, Feeding Behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Esophageal cancer patients recieving an esophagectomy
Key inclusion criteria (1 listed)
- any type of esophagectomy
Key exclusion criteria (2 listed)
- Preoperative organ metastasis (cM+ or yM+)
- esophageal bypass surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall 5 year survival
Time frame: 5 years after esophagectomy
Overall 5-year survival after esophagectomy for cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by University Hospital, Gasthuisberg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall 5 year survival (time frame: 5 years after esophagectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2013.