Nutrition Related Neoplasm/CancerNCT06368661
Dietary Factors Associated to Colorectal Premalignant Lesions (COLOMAR-1)
An observational study of Nutrition Related Neoplasm/Cancer, run by Fundación Vithas at 1 site in Spain.
Trial summary
This study aims to find a correlation between fish protein intake and other dietary habits and colorectal premalignant lesions in healthy volunteers. It also aims to describe gut microbial profiles for each dietary pattern, in order to elucidate the role of fish intake in cancer prevention. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrition Related Neoplasm/Cancer
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2023to 31 Dec 2024
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers from the general population above 45 years old.
Who may be able to join
- 45 years old or more.
- Be willing to participate in the study.
Who cannot join
- Pregnancy
- Previous colorectal cancer.
- Familial colorectal cancer syndrome.
- Previous colonoscopy and colon polypectomy (last five years ).
- Inflammatory bowel disease.
- Medical contraindication for colonoscopy at investigator´s criteria.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Ciro Cabezas Checchi
Vigo, Pontevedra, 36206
Ciro Cabezas Checchi, MD, +34 986 82 11 00, CabezasCC@vithas.es
About this study
This study aims to find a correlation between fish protein intake and other dietary habits and colorectal premalignant lesions in healthy volunteers. It also aims to describe gut microbial profiles for each dietary pattern, in order to elucidate the role of fish intake in cancer prevention.
Read the detailed description
Colorectal cancer incidence is increasing in developed countries specially among young adults due to risk factors as modern dietary, smoking, low physical exercise and obesity. Some foods (fruits, vegetables, nuts, other seeds and legumes) are assumed to prevent occurrence of colorectal cancer, while red and processed meat intake are strongly associated with increased risk of colorectal tumors. However, evidence on fish intake is still scarce, and the mechanisms and drivers of their potential health benefits are also only partially known. On the other hand, colonoscopy remains the gold standard for colon cancer screening. Our study aims to explore the relationship among fish intake, microbiota and molecular alterations during a colonoscopy screening program of healthy volunteers. This is a preliminary proof-of-concept study (ColoMAR-1) to evaluate the feasibility of the entire research program (ColoMAR-2).
The main objectives of this pilot are:
- To determinate the feasibility of the entire research project obtaining data for all the study participants (colonoscopy, blood sample, feces sample and dietary questionnaire).
- To evaluate the presence of precancerous lesions (colonic polyps) and colorectal malignant tumors in all the participants.
- To find molecular alterations (Alkylating signature) in normal mucosa of right and left-sided colon samples.
- To describe microbiota composition in all the participants.
- To determinate correlation between dietary habits and clinical and molecular findings of the study.
- To calculate the overall sample size of the entire research program (ColoMAR-2) in base to dietary patterns and Alkylating signature prevalence of the participants)
- Conditions
- Nutrition Related Neoplasm/Cancer
- Keywords
- Fish, Colon cancer, Rectal cancer
- Medical subject headings
- Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary habits registry from participants: the dietary intake
Dietary habits will be taken by an online specific Food Frequency Questionnaire (FFQ) for Spanish population. The data analysis will be taken at baseline outcome.
Measured: Dietary habits will be taken by an online specific Food Frequency Questionnaire (FFQ) for Spanish population. The data analysis will be taken at baseline outcome. 3 months
Biomarkers in colon mucosa, precancerous lesions and colorectal cancer
Alkylating signature will be determined in normal mucosa of right and left colon, premalignant lesions and colorectal cancer
Measured: 3 months
Gut microbiota profile
Differences in profile of gut microbiota among participants with and without precancerous lesions and colorectal cancer will be evaluated. Differences in profile of gut microbiota among different profiles of dietary habits will be evaluated.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Sep 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition Related Neoplasm/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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Vithas
- Sponsor type
- University, hospital or other
- Collaborators
- CEU San Pablo University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368661
- Sponsor's protocol ID
- 23.79 Colo-MAR 1
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Factors Associated to Colorectal Premalignant Lesions (COLOMAR-1)
- ClinicalTrials.gov ID
- NCT06368661
- Acronym / sponsor ID
- 23.79 Colo-MAR 1
- Conditions
- Nutrition Related Neoplasm/Cancer
- Keywords
- Fish, Colon cancer, Rectal cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundación VithasUniversity, hospital or other
- Collaborators
- CEU San Pablo University
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Apr 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.
This study aims to find a correlation between fish protein intake and other dietary habits and colorectal premalignant lesions in healthy volunteers. It also aims to describe gut microbial profiles for each dietary pattern, in order to elucidate the role of fish intake in cancer prevention.
Detailed description
Colorectal cancer incidence is increasing in developed countries specially among young adults due to risk factors as modern dietary, smoking, low physical exercise and obesity. Some foods (fruits, vegetables, nuts, other seeds and legumes) are assumed to prevent occurrence of colorectal cancer, while red and processed meat intake are strongly associated with increased risk of colorectal tumors. However, evidence on fish intake is still scarce, and the mechanisms and drivers of their potential health benefits are also only partially known. On the other hand, colonoscopy remains the gold standard for colon cancer screening. Our study aims to explore the relationship among fish intake, microbiota and molecular alterations during a colonoscopy screening program of healthy volunteers. This is a preliminary proof-of-concept study (ColoMAR-1) to evaluate the feasibility of the entire research program (ColoMAR-2).
The main objectives of this pilot are:
- To determinate the feasibility of the entire research project obtaining data for all the study participants (colonoscopy, blood sample, feces sample and dietary questionnaire).
- To evaluate the presence of precancerous lesions (colonic polyps) and colorectal malignant tumors in all the participants.
- To find molecular alterations (Alkylating signature) in normal mucosa of right and left-sided colon samples.
- To describe microbiota composition in all the participants.
- To determinate correlation between dietary habits and clinical and molecular findings of the study.
- To calculate the overall sample size of the entire research program (ColoMAR-2) in base to dietary patterns and Alkylating signature prevalence of the participants)
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers from the general population above 45 years old.
Key inclusion criteria (2 listed)
- 45 years old or more.
- Be willing to participate in the study.
Key exclusion criteria (6 listed)
- Pregnancy
- Previous colorectal cancer.
- Familial colorectal cancer syndrome.
- Previous colonoscopy and colon polypectomy (last five years ).
- Inflammatory bowel disease.
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
Dietary habits registry from participants: the dietary intake
Time frame: Dietary habits will be taken by an online specific Food Frequency Questionnaire (FFQ) for Spanish population. The data analysis will be taken at baseline outcome. 3 months
Dietary habits will be taken by an online specific Food Frequency Questionnaire (FFQ) for Spanish population. The data analysis will be taken at baseline outcome.
Biomarkers in colon mucosa, precancerous lesions and colorectal cancer
Time frame: 3 months
Alkylating signature will be determined in normal mucosa of right and left colon, premalignant lesions and colorectal cancer
Gut microbiota profile
Time frame: 4 months
Differences in profile of gut microbiota among participants with and without precancerous lesions and colorectal cancer will be evaluated. Differences in profile of gut microbiota among different profiles of dietary habits will be evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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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.
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 Nutrition Related Neoplasm/Cancer, run by Fundación Vithas at 1 site in Spain.
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 2 inclusion and 6 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 30 Jul 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 Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary habits registry from participants: the dietary intake (time frame: Dietary habits will be taken by an online specific Food Frequency Questionnaire (FFQ) for Spanish population. The data analysis will be taken at baseline outcome. 3 months). The study lists 3 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 Jul 2024.