Colorectal CancerNCT06748339
Gut Microbiome and Colorectal Cancer
An observational study of Colorectal Cancer, run by Heliopolis University at 1 site in Egypt.
Trial summary
Colorectal cancer (CRC) is reported to be the third leading cause of cancer deaths worldwide, and its prevalence is steadily rising in developing countries. It can be considered a marker of socioeconomic development and a marker of significant changes in food habits and lifestyle. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 17 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 12 newly diagnosed CRC patiens vs 6 healthy voulnteers
Who may be able to join
- Age of 40 years to 80 years
- Patients with a newly diagnosed CRC
Who cannot join
- Patients with previously known CRC
- Pregnancy or Lactation
- Abdominal surgery within/up to 6 months prior to sample collection
- Antibiotics, corticosteroids, or probiotics up to three months prior to sample collection
- History of other types of cancer
- Subjects on a special diet
- Diabetes, liver, or kidney diseases
- CRC patients who used enema or underwent colonoscopy up to one week before sample collection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gut Microbiome Dyspiosis in Colorectal Cancer Egyptian Patients
Colorectal cancer (CRC) is reported to be the third leading cause of cancer deaths worldwide, and its prevalence is steadily rising in developing countries. It can be considered a marker of socioeconomic development and a marker of significant changes in food habits and lifestyle. In Egypt, CRC represents the seventh most common cancer. It is the third most reported cancer in males and the fifth most common cancer in females. microbiome dysbiosis may be involved in the pathogensis and thus pose a therapeutic target
Read the detailed description
Many reports suggested the role of westernized dietary lifestyles, including high consumption of red meats, animal fats, and cholesterol-rich foods, as well as smoking, decreased physical activity, obesity, diabetes, alcohol consumption, or smoking, in CRC development. These changes in lifestyle are called the external factors, which are now linked to changes in the inner gut microenvironments, mainly the microbiomes. Our aim is to investigate the the changes in microbiome profile in relation to clinical, pathological and lifestyle factors
- Conditions
- Colorectal Cancer
- Being tested
- no intervention
- Keywords
- CRC, microbiome
- 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 interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| contol group | 6 healthy participants Receives: Other: no intervention | |
| CRC group | 12 newly diagnosed CRC patients Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of food and lifestyle on microbiome
correlation between food and lifestyle with microbiome profiles
Measured: "through study completion, an average of 1 year"
microbiome profile and CRC pathogensis
correlation between microbiome profile and CRC pathogensis
Measured: "through study completion, an average of 1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jan 2024
- Primary completion17 Sep 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heliopolis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara mostafa ElAdawy, Heliopolis University
- Investigators
- sara M eladwy, Principal investigator, Heliopolis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748339
- Sponsor's protocol ID
- HU.REC.H10-2024
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients' information will be assigned codes. no need to reveal it
Publications
Baas FS, Brusselaers N, Nagtegaal ID, Engstrand L, Boleij A. Navigating beyond associations: Opportunities to establish causal relationships between the gut microbiome and colorectal carcinogenesis. Cell Host Microbe. 2024 Aug 14;32(8):1235-1247. doi: 10.1016/j.chom.2024.07.008.
PubMed 39146796
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiome Dyspiosis in Colorectal Cancer Egyptian Patients
- ClinicalTrials.gov ID
- NCT06748339
- Acronym / sponsor ID
- HU.REC.H10-2024
- Conditions
- Colorectal Cancer
- Keywords
- CRC, microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Heliopolis UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 17 Sep 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 27 Dec 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.
Colorectal cancer (CRC) is reported to be the third leading cause of cancer deaths worldwide, and its prevalence is steadily rising in developing countries. It can be considered a marker of socioeconomic development and a marker of significant changes in food habits and lifestyle. In Egypt, CRC represents the seventh most common cancer. It is the third most reported cancer in males and the fifth most common cancer in females. microbiome dysbiosis may be involved in the pathogensis and thus pose a therapeutic target
Detailed description
Many reports suggested the role of westernized dietary lifestyles, including high consumption of red meats, animal fats, and cholesterol-rich foods, as well as smoking, decreased physical activity, obesity, diabetes, alcohol consumption, or smoking, in CRC development. These changes in lifestyle are called the external factors, which are now linked to changes in the inner gut microenvironments, mainly the microbiomes. Our aim is to investigate the the changes in microbiome profile in relation to clinical, pathological and lifestyle factors
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| contol group | – | Other: no intervention6 healthy participants |
| CRC group | – | Other: no intervention12 newly diagnosed CRC patients |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 12 newly diagnosed CRC patiens vs 6 healthy voulnteers
Key inclusion criteria (2 listed)
- Age of 40 years to 80 years
- Patients with a newly diagnosed CRC
Key exclusion criteria (8 listed)
- Patients with previously known CRC
- Pregnancy or Lactation
- Abdominal surgery within/up to 6 months prior to sample collection
- Antibiotics, corticosteroids, or probiotics up to three months prior to sample collection
- History of other types of cancer
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 interventionno intervention | Other | CRC group, contol group |
Primary outcome
The effect of food and lifestyle on microbiome
Time frame: "through study completion, an average of 1 year"
correlation between food and lifestyle with microbiome profiles
microbiome profile and CRC pathogensis
Time frame: "through study completion, an average of 1 year"
correlation between microbiome profile and CRC pathogensis
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 Dec 2024.
- Background: PubMed 39146796Baas FS, Brusselaers N, Nagtegaal ID, Engstrand L, Boleij A. Navigating beyond associations: Opportunities to establish causal relationships between the gut microbiome and colorectal carcinogenesis. Cell Host Microbe. 2024 Aug 14;32(8):1235-1247. doi: 10.1016/j.chom.2024.07.008.
- Navigating beyond associations: Opportunities to establish causal relationships between the gut microbiome and colorectal carcinogenesisLink provided by the sponsor.
- Individual participant dataSharing planned: No. Patients' information will be assigned codes. no need to reveal it
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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.
sara M eladwy principal investigator
Heliopolis University
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 Colorectal Cancer, run by Heliopolis University at 1 site in Egypt.
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 8 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 Dec 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 Egypt. 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?
The effect of food and lifestyle on microbiome (time frame: "through study completion, an average of 1 year"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06748339, which also lists 1 linked publication.
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 Dec 2024.