The Aim of This Study is to Determine the Influence of BMI and Lymph Node Status on OS in CRC Patients in the Long TermNCT06334926
BMI and Lymph Node Count in Colorectal Cancer
An observational study of The Aim of This Study is to Determine the Influence of BMI and Lymph Node Status on OS in CRC Patients in the Long Term, run by Klinikum Floridsdorf at 1 site in Austria.
Trial summary
Background and aim: Colorectal Cancer (CRC) is one of the most frequent cancer entities in the western world. It is known that obesity is one of the major risk factors for CRC. In contrast, mild obesity seems to have a positive effect on postoperative outcome, which is known as the "obesity paradox". Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- The Aim of This Study is to Determine the Influence of BMI and Lymph Node Status on OS in CRC Patients in the Long Term
- How many people
- 1,192 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2017to 31 Mar 2020
- How long will I take part?
- 11 Years
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had surgery at the department of surgery at the Klinik Favoriten between 1998 and 2011 were analyzed. 1192 patients met the inclusion criteria were therefore pseudonymized and recorded in a newly developed database.
Who may be able to join
- colorectal carcinoma
- treated at the Klinik Favoriten between 1998 and 2011
- elective or acute surgical setting
- curative intent
- older than 18 years
Who cannot join
- other carcinoma (anal, metastases, ...)
- treated before 1998 or after 2011
- palliative intent
- younger than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Survival in Colorectal Cancer Patients on the Basis of Body Mass Index and Lymph Node Yield - a Retrospective Single Center Cohort Analysis Over a Quarter of a Century
Background and aim: Colorectal Cancer (CRC) is one of the most frequent cancer entities in the western world. It is known that obesity is one of the major risk factors for CRC. In contrast, mild obesity seems to have a positive effect on postoperative outcome, which is known as the "obesity paradox". Also, the number of resected lymph nodes (LN) during surgery is very important for correct staging. The aim of the present project is to evaluate the impact of BMI and LN-yield on long term overall survival (OS) of CRC patients treated with curative intent.
Methods: Patients treated for CRC between 1998 and 2011 at the Klinik Favoriten in Vienna, Austria were analyzed in this retrospective single-center cohort analysis concerning OS.
- Being tested
- no intervention, retrospective data analysis
- Keywords
- colorectal cancer, survival, prognostic factors, body mass index, obesity paradox, lymph node count
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, retrospective data analysisOther
not applicable, retrospective data analysis
| Study group | Role | What they receive |
|---|---|---|
| Colon cancer patients | Retrospective data analysis of the subgroup of patients suffering from colon carcinoma Receives: Other: no intervention, retrospective data analysis | |
| Rectal cancer patients | Retrospective data analysis of the subgroup of patients suffering from rectal carcinoma Receives: Other: no intervention, retrospective data analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
The aim of the present project is to evaluate the impact of BMI and LN-yield on long term overall survival (OS) of CRC patients treated with curative intent.
Measured: median follow up of 11.3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Dec 2017
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Aim of This Study is to Determine the Influence of BMI and Lymph Node Status on OS in CRC Patients in the Long TermStudies 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
- Other
- Enrolment
- 1,192 participants (actual)
- Target duration
- 11 Years
Sponsor and investigators
- Lead sponsor
- Klinikum Floridsdorf
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna, Klinik Favoriten, Salzkammergut Klinikum Vöcklabruck
- Responsible party
- Principal investigator, Dr. Tamara Braunschmid, Klinikum Floridsdorf
- Investigators
- Tamara Braunschmid, MD, Principal investigator, Klinik Floridsdorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334926
- Sponsor's protocol ID
- EK 18-002-VK
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All relevant data will be shared within a publication of the study. Detailled data are available upon request
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Survival in Colorectal Cancer Patients on the Basis of Body Mass Index and Lymph Node Yield - a Retrospective Single Center Cohort Analysis Over a Quarter of a Century
- ClinicalTrials.gov ID
- NCT06334926
- Acronym / sponsor ID
- EK 18-002-VK
- Keywords
- colorectal cancer, survival, prognostic factors, body mass index, obesity paradox, lymph node count
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,192 participants (actual)
- Lead sponsor
- Klinikum FloridsdorfUniversity, hospital or other
- Collaborators
- Medical University of Vienna, Klinik Favoriten, Salzkammergut Klinikum Vöcklabruck
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 28 Mar 2024 (actual)
- 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.
Background and aim: Colorectal Cancer (CRC) is one of the most frequent cancer entities in the western world. It is known that obesity is one of the major risk factors for CRC. In contrast, mild obesity seems to have a positive effect on postoperative outcome, which is known as the "obesity paradox". Also, the number of resected lymph nodes (LN) during surgery is very important for correct staging. The aim of the present project is to evaluate the impact of BMI and LN-yield on long term overall survival (OS) of CRC patients treated with curative intent.
Methods: Patients treated for CRC between 1998 and 2011 at the Klinik Favoriten in Vienna, Austria were analyzed in this retrospective single-center cohort analysis concerning OS.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 11 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colon cancer patients | – | Other: no intervention, retrospective data analysisRetrospective data analysis of the subgroup of patients suffering from colon carcinoma |
| Rectal cancer patients | – | Other: no intervention, retrospective data analysisRetrospective data analysis of the subgroup of patients suffering from rectal carcinoma |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had surgery at the department of surgery at the Klinik Favoriten between 1998 and 2011 were analyzed. 1192 patients met the inclusion criteria were therefore pseudonymized and recorded in a newly developed database.
Key inclusion criteria (5 listed)
- colorectal carcinoma
- treated at the Klinik Favoriten between 1998 and 2011
- elective or acute surgical setting
- curative intent
- older than 18 years
Key exclusion criteria (4 listed)
- other carcinoma (anal, metastases, ...)
- treated before 1998 or after 2011
- palliative intent
- younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention, retrospective data analysisnot applicable, retrospective data analysis | Other | Colon cancer patients, Rectal cancer patients |
Primary outcome
overall survival
Time frame: median follow up of 11.3 years
The aim of the present project is to evaluate the impact of BMI and LN-yield on long term overall survival (OS) of CRC patients treated with curative intent.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No. All relevant data will be shared within a publication of the study. Detailled data are available upon request
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.
Tamara Braunschmid, MD principal investigator
Klinik Floridsdorf
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 The Aim of This Study is to Determine the Influence of BMI and Lymph Node Status on OS in CRC Patients in the Long Term, run by Klinikum Floridsdorf at 1 site in Austria.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 28 Mar 2024. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 survival (time frame: median follow up of 11.3 years). 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 28 Mar 2024; AzTrials last refreshed its copy on 30 Oct 2026.