Colorectal CancerNCT02884024
Effects of Weight on Inflammation and Colon Cancer Risk
An observational study of Colorectal Cancer, run by Tufts University.
Trial summary
An observational study designed to compare colonic cytokine concentrations in lean versus obese individuals Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Feb 2013
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 43 generally healthy adults of both genders undergoing routine screening colonoscopy at Tufts Medical Center
Who may be able to join
- Caucasian
- undergoing clinically-indicated screening colonoscopy
- BMI< or = 25, or 30+
Who cannot join
- past history of cancer (except non-melanoma skin cancer)
- a polyposis syndrome
- any current or chronic inflammatory disease or infection
- incapable of providing valid informed consent
About this study
Official title: Study on the Effects of Weight on Inflammation and Colon Cancer Risk
An observational study designed to compare colonic cytokine concentrations in lean versus obese individuals
Read the detailed description
An observational study was performed on 43 individuals undergoing routine screening colonoscopy, some of whom were lean and some who were obese. They had weight, height, and waist-hip ratio measured at the time of colonoscopy and had additional colonic biopsies to measure colonic cytokines.
- Conditions
- Colorectal Cancer
- Being tested
- no intervention
- Keywords
- obesity, inflammation, cancer risk
- Medical subject headings
- Colorectal Neoplasms, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
there is no intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| lean | healthy subject undergoing routine screening colonoscopy, BMI< or = 25 Receives: Other: no intervention | |
| mildly obese | healthy subject undergoing routine screening colonoscopy, BMI 30-33.9 Receives: Other: no intervention | |
| moderate-to-severe obese | healthy subject undergoing routine screening colonoscopy, BMI 34+ Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
colonic concentration of Tumor Necrosis Factor-alpha
Measured: time zero: at baseline
colonic concentration of Interleukin-6
Measured: time zero: at baseline
colonic concentration of Interleukin-1 beta
Measured: time zero: at baseline
colonic concentration of Interferon-gamma
Measured: time zero: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startJan 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts Medical Center
- Responsible party
- Principal investigator, Joel Mason, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884024
- Sponsor's protocol ID
- 10103
- Status last verified
- Aug 2016
- First submitted
- 23 Aug 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effects of Weight on Inflammation and Colon Cancer Risk
- ClinicalTrials.gov ID
- NCT02884024
- Acronym / sponsor ID
- 10103
- Conditions
- Colorectal Cancer
- Keywords
- obesity, inflammation, cancer risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Tufts Medical Center
- Study start
- Jan 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 30 Aug 2016 (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.
An observational study designed to compare colonic cytokine concentrations in lean versus obese individuals
Detailed description
An observational study was performed on 43 individuals undergoing routine screening colonoscopy, some of whom were lean and some who were obese. They had weight, height, and waist-hip ratio measured at the time of colonoscopy and had additional colonic biopsies to measure colonic cytokines.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lean | – | Other: no interventionhealthy subject undergoing routine screening colonoscopy, BMI< or = 25 |
| mildly obese | – | Other: no interventionhealthy subject undergoing routine screening colonoscopy, BMI 30-33.9 |
| moderate-to-severe obese | – | Other: no interventionhealthy subject undergoing routine screening colonoscopy, BMI 34+ |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 43 generally healthy adults of both genders undergoing routine screening colonoscopy at Tufts Medical Center
Key inclusion criteria (3 listed)
- Caucasian
- undergoing clinically-indicated screening colonoscopy
- BMI< or = 25, or 30+
Key exclusion criteria (4 listed)
- past history of cancer (except non-melanoma skin cancer)
- a polyposis syndrome
- any current or chronic inflammatory disease or infection
- incapable of providing valid informed consent
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 interventionthere is no intervention in this study | Other | lean, mildly obese, moderate-to-severe obese |
Primary outcome
colonic concentration of Tumor Necrosis Factor-alpha
Time frame: time zero: at baseline
colonic concentration of Interleukin-6
Time frame: time zero: at baseline
colonic concentration of Interleukin-1 beta
Time frame: time zero: at baseline
colonic concentration of Interferon-gamma
Time frame: time zero: at baseline
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 30 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Tufts University.
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 3 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 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
colonic concentration of Tumor Necrosis Factor-alpha (time frame: time zero: at baseline). The study lists 4 primary outcomes in all. 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 30 Aug 2016.