CancerCCR-microbiotaNCT04662853
Gut Microbiota and Color-rectal Cancer.
An observational study of Cancer and Colo-rectal Cancer, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
This clinical trial is focused in the development of a screening test for the people at risk of colo-rectal cancer (aged more than 50 years old), valid and safe, improving the screening prognosis increasing the sensitivity and sensitive as compared with the current method, fecal occult blood. Read more about this study
- Who is it for?
- Ages 50 to 69 years
- Conditions the study is for
- Cancer, Colo-rectal Cancer, Diagnoses Disease
- What is being tested?
- Gut microbiota determination from feces samples.
- How many people
- 153 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jan 2017to 31 Jul 2021
- How long will I take part?
- 1 Month
- 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 50 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with positive results in the fecal occult blood test in the Program for Early Detection of Colon and Rectal Cancer, undergone by the Consejeria de Salud de la Junta de Andalucia (Spain), were invited to participate in the CCR-microbiome study. This program is screening Andalusian population aged between 50 and 69 years old for colo-rectal cancer presence by fecal occult blood test, and further colonoscopy when positive for this test. Patients included in CCR-microbiome study were recruited between January 2017 and March 2020, at the Reina Sofia University Hospital (Cordoba, Spain) with the consumption of antibiotic within the previous month as exclusion criteria.
Who may be able to join
- -Patients with positive results in the fecal occult blood test in the Program for Early Detection of Colon and Rectal Cancer, undergone by the Consejeria de Salud de la Junta de Andalucia (Spain).
Who cannot join
- -The consumption of antibiotic within the previous month to inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gut Microbiota-based Tool for the Detection of Color-rectal Cancer in Positive Patients for the Fecal Occult Blood Test.
This clinical trial is focused in the development of a screening test for the people at risk of colo-rectal cancer (aged more than 50 years old), valid and safe, improving the screening prognosis increasing the sensitivity and sensitive as compared with the current method, fecal occult blood.
Read the detailed description
Colo-rectal cancer (CCR) is one of the most prevalent cancers in developed countries. Several studies suggest that the CCR may be related with changes in the gut microbiota. This clinical trial is focused in the development of a screening test for the people at risk of CCR (aged more than 50 years old), valid and safe, improving the screening prognosis. The main potential improvement lies in the fact that the proposed method is more specific and sensitive than the current method, fecal occult blood. It aims to distinguish whether the positive results for fecal occult blood test is due to fissures, not related with CCR (which are positive for fecal occult blood, false positive) or was caused by a cancer-related lesion. The methodology derived will also improve the sensitive as sometimes the polyps do not leak blood. Based in the previous differences found in the gut microbiota composition related with CCR for several research groups, the gut microbiota composition will be used as diagnosis tool.
- Conditions
- Cancer, Colo-rectal Cancer, Diagnoses Disease, Microbiota-related Disease, Intestinal Disease
- Being tested
- Gut microbiota determination from feces samples.
- Keywords
- Diagnosis improvement, Early diagnosis, Mathematical modelling, Gut microbiota, Colonoscopy
- Medical subject headings
- Neoplasms, Colonic Neoplasms, Intestinal Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gut microbiota determination from feces samples.Diagnostic test
Also called Colonoscopy
Determination of the gut microbiota composition by 16S metagenomic and building of a mathematical model, on the basis of the colonoscopies results, able to classify patients without and with color-rectal cancer-related lessions. These latter will be also classified according to the type of lession.
| Study group | Role | What they receive |
|---|---|---|
| Patients with positive results in the fecal occult blood test. | Patients with positive results in the fecal occult blood test in the Program for Early Detection of Colon and Rectal Cancer, undergone by the Consejeria de Salud de la Junta de Andalucia (Spain), were invited to participate in the CCR-microbiome study. This program is screening Andalusian population aged between 50 and 69 years old for colo-rectal cancer presence by fecal occult blood test, and further colonoscopy when positive for this test. Patients included in CCR-microbiome study were recruited between January 2017 and March 2020, at the Reina Sofia University Hospital (Cordoba, Spain) with the consumption of antibiotic within the previous month as exclusion criteria. Receives: Diagnostic Test: Gut microbiota determination from feces samples. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut-microbiota-based color-rectal cancer diagnosis.
Determination of the gut microbiota composition by 16S metagenomic, data analysis and building of a mathematical model to test the potential use of the gut microbiota architecture as biomarker to color-rectal cancer prognosis in patients with positive results in fecal occult blood test.
Measured: A week before colonoscopy.
Secondary outcomes (3)
Colonoscopy clinical results.
Prevalence of the different color-rectal cancer lessions.
Measured: At week 2.
Characteristic of the population.
The characteristic of the population includes gender (man/woman), age (years), weight in kilograms and height in meters (weight and height will be combined to report BMI in kg/m^2), which will be used to check for any association with the prevalence of the different color-rectal cancer lesions.
Measured: A week before colonoscopy.
Dietary habits
The dietary habits will be assessed by a questionnaire and will be used to check for any association with the prevalence of the different color-rectal cancer lessions.
Measured: A week before colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start17 Jan 2017
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- Reina Sofia University Hospital, Junta de Andalucia
- Responsible party
- Sponsor
- Investigators
- Antonio Hervas, Study director, Reina Sofia University HospitalCarmen Haro, PhD, Study director, Maimonides Institute for Biomedical ResearchAntonio Camargo, PhD, Principal investigator, Maimonides Institute for Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662853
- Sponsor's protocol ID
- CCR early diagnosis
- Acronym
- CCR-microbiota
- Status last verified
- Dec 2020
- First submitted
- 19 Nov 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Microbiota row data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota-based Tool for the Detection of Color-rectal Cancer in Positive Patients for the Fecal Occult Blood Test.
- ClinicalTrials.gov ID
- NCT04662853
- Acronym / sponsor ID
- CCR-microbiota / CCR early diagnosis
- Conditions
- Cancer, Colo-rectal Cancer, Diagnoses Disease, Microbiota-related Disease, Intestinal Disease
- Keywords
- Diagnosis improvement, Early diagnosis, Mathematical modelling, Gut microbiota, Colonoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Collaborators
- Reina Sofia University Hospital, Junta de Andalucia
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 10 Dec 2020 (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 clinical trial is focused in the development of a screening test for the people at risk of colo-rectal cancer (aged more than 50 years old), valid and safe, improving the screening prognosis increasing the sensitivity and sensitive as compared with the current method, fecal occult blood.
Detailed description
Colo-rectal cancer (CCR) is one of the most prevalent cancers in developed countries. Several studies suggest that the CCR may be related with changes in the gut microbiota. This clinical trial is focused in the development of a screening test for the people at risk of CCR (aged more than 50 years old), valid and safe, improving the screening prognosis. The main potential improvement lies in the fact that the proposed method is more specific and sensitive than the current method, fecal occult blood. It aims to distinguish whether the positive results for fecal occult blood test is due to fissures, not related with CCR (which are positive for fecal occult blood, false positive) or was caused by a cancer-related lesion. The methodology derived will also improve the sensitive as sometimes the polyps do not leak blood. Based in the previous differences found in the gut microbiota composition related with CCR for several research groups, the gut microbiota composition will be used as diagnosis tool.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with positive results in the fecal occult blood test. | – | Diagnostic Test: Gut microbiota determination from feces samples.Patients with positive results in the fecal occult blood test in the Program for Early Detection of Colon and Rectal Cancer, undergone by the Consejeria de Salud de la Junta de Andalucia (Spain), were invited to participate in the CCR-microbiome study. This program is screening Andalusian population aged between 50 and 69 years old for colo-rectal cancer presence by fecal occult blood test, and further colonoscopy when positive for this test. Patients included in CCR-microbiome study were recruited between January 2017 and March 2020, at the Reina Sofia University Hospital (Cordoba, Spain) with the consumption of antibiotic within the previous month as exclusion criteria. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with positive results in the fecal occult blood test in the Program for Early Detection of Colon and Rectal Cancer, undergone by the Consejeria de Salud de la Junta de Andalucia (Spain), were invited to participate in the CCR-microbiome study. This program is screening Andalusian population aged between 50 and 69 years old for colo-rectal cancer presence by fecal occult blood test, and further colonoscopy when positive for this test. Patients included in CCR-microbiome study were recruited between January 2017 and March 2020, at the Reina Sofia University Hospital (Cordoba, Spain) with the consumption of antibiotic within the previous month as exclusion criteria.
Key inclusion criteria (1 listed)
- -Patients with positive results in the fecal occult blood test in the Program for Early Detection of Colon and Rectal Cancer, undergone by the Consejeria de Salud de la Junta de Andalucia (Spain).
Key exclusion criteria (1 listed)
- -The consumption of antibiotic within the previous month to inclusion in the study.
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 |
|---|---|---|
| Gut microbiota determination from feces samples.Also: ColonoscopyDetermination of the gut microbiota composition by 16S metagenomic and building of a mathematical model, on the basis of the colonoscopies results, able to classify patients without and with color-rectal cancer-related lessions. These latter will be also classified according to the type of lession. | Diagnostic test | Patients with positive results in the fecal occult blood test. |
Primary outcome
Gut-microbiota-based color-rectal cancer diagnosis.
Time frame: A week before colonoscopy.
Determination of the gut microbiota composition by 16S metagenomic, data analysis and building of a mathematical model to test the potential use of the gut microbiota architecture as biomarker to color-rectal cancer prognosis in patients with positive results in fecal occult blood test.
3 secondary outcomes
Colonoscopy clinical results.
Time frame: At week 2.
Characteristic of the population.
Time frame: A week before colonoscopy.
Dietary habits
Time frame: A week before colonoscopy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Individual participant dataSharing planned: Undecided. Microbiota row data.
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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.
Antonio Hervas study director
Reina Sofia University Hospital
Carmen Haro, PhD study director
Maimonides Institute for Biomedical Research
Antonio Camargo, PhD principal investigator
Maimonides Institute for Biomedical Research
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 Cancer and Colo-rectal Cancer, run by Maimónides Biomedical Research Institute of Córdoba 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 1 inclusion and 1 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 10 Dec 2020. 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?
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?
Gut-microbiota-based color-rectal cancer diagnosis. (time frame: A week before colonoscopy.). 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 10 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.