Colorectal Adenoma and CarcinomaNCT02947607
Investigation of the Role of the Microbiome in the Pathogenesis of Colorectal Adenoma and Carcinoma
An observational study of Colorectal Adenoma and Carcinoma, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in 2 countries.
Trial summary
The purpose of this study is the investigation of new host-microbiome interactions promoting adenoma formation and adenocarcinoma progression. For that purpose, the investigators will collect saliva, stool and colon biopsy specimens from patients referred to colonoscopy or surgical resection of colorectal tumor. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Adenoma and Carcinoma
- What is being tested?
- Colon biopsies
- Type of treatment
- Surgery or procedure
- How many people
- 799 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2016to Apr 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants are patients with CRC that will undergo surgical tumor resection or patients referred for lower GI endoscopy.
Who may be able to join
- Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed
- Male or female, aged 18 years or above
- Referred to lower GI endoscopy. Referral reasons can be among others:
- Positive FOBT (Fecal Occult Blood Test)
- Follow up after polypectomy
- Screening because of age
Show all 16Show fewer
- Bleeding
- Abdominal pain
- Familial or past history of colon cancer or adenoma
- Abnormal imaging such as barium enema
- Change in bowel habits
- Both self-referrals, referrals from external GP or specialists and internal referrals can be included.
- Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed
- Male or female, aged 18 years or above
- Diagnosis of CRC for which resection is planned
- Both internal and external referrals from specialists can be included
Who cannot join
- Previous diagnosis of an inflammatory bowel disease
- Previous diagnosis of intestinal polyposis syndrome
- CRC patients
- Previous diagnosis of an inflammatory bowel disease
- Previous diagnosis of intestinal polyposis syndrome
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The purpose of this study is the investigation of new host-microbiome interactions promoting adenoma formation and adenocarcinoma progression. For that purpose, the investigators will collect saliva, stool and colon biopsy specimens from patients referred to colonoscopy or surgical resection of colorectal tumor. Besides, a questionnaire about diet, lifestyle and medical history will be collected. Sample analysis will involve simultaneous characterization of host and microbiota genomic and transcriptomic components.
- Conditions
- Colorectal Adenoma and Carcinoma
- Being tested
- Colon biopsies
- Keywords
- Human gut microbiome, Colorectal cancer, Colorectal adenoma, Gut bacteria, Metagenomics, Metatranscriptomics
- Medical subject headings
- Carcinoma, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon biopsiesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Healthy control | Patients undergoing lower GI endoscopy without any colorectal adenoma or carcinoma. Receives: Procedure: Colon biopsies | |
| Adenoma | Patients undergoing lower GI endoscopy with presence of colorectal adenoma detected. Receives: Procedure: Colon biopsies | |
| Colorectal cancer | Patients diagnosed with colorectal cancer and referred to surgical carcinoma resection. Receives: Procedure: Colon biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential host microbiome composition and abundance in healthy, adenoma and CRC patients and its correlation to CRC risk features and host genomic and transcriptomic components.
Host microbiome composition and abundance data will be generated from saliva, stool and colonic biopsies with amplicon-based 16S ribosomal RNA sequencing. This data will be correlated to CRC risk factors collected in a questionnaire covering lifestyle, diet and medical history as well as host genomic and transcriptomic profiling generated by targeted gene sequencing and microarray-based gene expression profiling.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Adenoma and CarcinomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 799 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceutica N.V., Belgium, KU Leuven
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947607
- Sponsor's protocol ID
- s57084
- Status last verified
- May 2018
- First submitted
- 13 Oct 2016
- Last updated
- 27 Jan 2023
- 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 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Role of the Microbiome in the Pathogenesis of Colorectal Adenoma and Carcinoma
- ClinicalTrials.gov ID
- NCT02947607
- Acronym / sponsor ID
- s57084
- Conditions
- Colorectal Adenoma and Carcinoma
- Keywords
- Human gut microbiome, Colorectal cancer, Colorectal adenoma, Gut bacteria, Metagenomics, Metatranscriptomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 799 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Janssen Pharmaceutica N.V., Belgium, KU Leuven
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 28 Oct 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.
The purpose of this study is the investigation of new host-microbiome interactions promoting adenoma formation and adenocarcinoma progression. For that purpose, the investigators will collect saliva, stool and colon biopsy specimens from patients referred to colonoscopy or surgical resection of colorectal tumor. Besides, a questionnaire about diet, lifestyle and medical history will be collected. Sample analysis will involve simultaneous characterization of host and microbiota genomic and transcriptomic components.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control | – | Procedure: Colon biopsiesPatients undergoing lower GI endoscopy without any colorectal adenoma or carcinoma. |
| Adenoma | – | Procedure: Colon biopsiesPatients undergoing lower GI endoscopy with presence of colorectal adenoma detected. |
| Colorectal cancer | – | Procedure: Colon biopsiesPatients diagnosed with colorectal cancer and referred to surgical carcinoma resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants are patients with CRC that will undergo surgical tumor resection or patients referred for lower GI endoscopy.
Key inclusion criteria (16 listed)
- Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed
- Male or female, aged 18 years or above
- Referred to lower GI endoscopy. Referral reasons can be among others:
- Both self-referrals, referrals from external GP or specialists and internal referrals can be included.
- Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed
Key exclusion criteria (5 listed)
- Previous diagnosis of an inflammatory bowel disease
- Previous diagnosis of intestinal polyposis syndrome
- CRC patients
- Previous diagnosis of an inflammatory bowel disease
- Previous diagnosis of intestinal polyposis syndrome
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 |
|---|---|---|
| Colon biopsies | Procedure or surgery | Adenoma, Colorectal cancer, Healthy control |
Primary outcome
Differential host microbiome composition and abundance in healthy, adenoma and CRC patients and its correlation to CRC risk features and host genomic and transcriptomic components.
Time frame: 2 years
Host microbiome composition and abundance data will be generated from saliva, stool and colonic biopsies with amplicon-based 16S ribosomal RNA sequencing. This data will be correlated to CRC risk factors collected in a questionnaire covering lifestyle, diet and medical history as well as host genomic and transcriptomic profiling generated by targeted gene sequencing and microarray-based gene expression profiling.
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 27 Jan 2023.
- 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Adenoma and Carcinoma, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in 2 countries.
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 16 inclusion and 5 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 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. 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?
Differential host microbiome composition and abundance in healthy, adenoma and CRC patients and its correlation to CRC risk features and host genomic and transcriptomic components. (time frame: 2 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 27 Jan 2023.