Colorectal Cancer Stage IVNCT04149613
Predictive and Prognostic Value of Inflammatory Markers and microRNA in Stage IV Colorectal Cancer
An observational study of Colorectal Cancer Stage IV, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
This study investigates the predictive and prognostic values of inflammatory markers and microRNA in stage IV colorectal cancer. The expression of inflammatory markers and microRNA in plasma will be correlated with tumor location, with dietary patterns and with survival during treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Stage IV
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteLebanon
- Study dates
- 25 May 2018to 15 Jul 2026
- 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: Primary physicians will identify patients who are treatment naïve, stage IV colorectal cancer patients, and exclude the patients, who have a history of an inflammatory bowel disease, or an active systemic autoimmune disease, and who have a chronic / recent use of corticosteroids or on immunosuppressant drugs therapy. Recruitment will be done for patients admitted to the chemotherapy infusion unit at the Naef K. Basile Cancer Institution at the American University of Beirut Medical Center.
Who may be able to join
- Newly diagnosed Stage IV colorectal cancer
- Treatment naïve
- For the control group: adult individuals (above 18 years) with no cancer disease
Who cannot join
- Any disease or condition that may alter the inflammatory and immune status of subjects at baseline, such as:
- Diagnosis of inflammatory bowel disease such as ulcerative colitis and crohn's disease.
- Diagnosis of active systemic autoimmune disease
- Chronic / recent use of corticosteroids
- Use of immunosuppressant drugs
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the predictive and prognostic values of inflammatory markers and microRNA in stage IV colorectal cancer. The expression of inflammatory markers and microRNA in plasma will be correlated with tumor location, with dietary patterns and with survival during treatment.
Read the detailed description
Colorectal cancer (CRC) is responsible for 10% of the world-wide cancer incidence and mortality. Recent data have shown that tumors arising from different regions of the colon differ in their molecular characteristics which causes translate into a differential clinical outcome.Several studies described the role of microRNA expression in the initiation and progression of CRC and its response to different therapeutic strategies. Other studies have shown that systemic inflammation is a key determinant role of clinico-pathological outcomes in patients with CRC. We therefore aim to evaluate the expression of selected microRNA and inflammatory markers in patients with stage IV colorectal cancer and assess their correlation with tumor location, dietary patterns, survival rates, response to systemic chemotherapy and other clinic-pathological parameters. We believe that identifying a predictive and prognostic panel made up of circulating microRNA and inflammatory markers may perhaps explain the difference in outcome between right and left colon and perhaps impact the clinical practice in patients with stage IV colorectal cancer.
- Conditions
- Colorectal Cancer Stage IV
- Keywords
- biomarker, colorectal cancer, prognosis, prediction, microRNA, inflammation, dietary pattern
- Medical subject headings
- Colorectal Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal Cancer Patients | Newly diagnosed stage IV colorectal cancer patients | |
| Controls | cancer free |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of inflammatory markers
Level of C-reactive protein (CRP), Erythrocyte sedimentation rate (ESR), serum albumin, fibrinogen, haptoglobin, lymphocyte monocyte ratio (LMR), neutrophil lymphocyte ratio (NLR) and platelets lymphocytes ratio (PLR)
Measured: At diagnosis before chemotherapy
microRNA expression Level
miR-21, miR-19a, miR-155, miR-200c, miR-210, miR-126, miR-345, miR-31, miR-29a, miR-200b, and miR-203
Measured: At diagnosis before chemotherapy
Secondary outcomes (1)
Dietary pattern
Associations of dietary patterns (such as the Mediterranean diet and DII) with inflammatory markers, and microRNA expression
Measured: At diagnosis before chemotherapy and every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start25 May 2018
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Stage IVStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Temraz, American University of Beirut Medical Center
- Investigators
- Sally Temraz, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149613
- Sponsor's protocol ID
- Bio-2018-0041
- Status last verified
- Jul 2024
- First submitted
- 31 Oct 2019
- Last updated
- 31 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 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive and Prognostic Value of Inflammatory Markers and microRNA in Stage IV Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04149613
- Acronym / sponsor ID
- Bio-2018-0041
- Conditions
- Colorectal Cancer Stage IV
- Keywords
- biomarker, colorectal cancer, prognosis, prediction, microRNA, inflammation, dietary pattern
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 25 May 2018 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 4 Nov 2019 (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 investigates the predictive and prognostic values of inflammatory markers and microRNA in stage IV colorectal cancer. The expression of inflammatory markers and microRNA in plasma will be correlated with tumor location, with dietary patterns and with survival during treatment.
Detailed description
Colorectal cancer (CRC) is responsible for 10% of the world-wide cancer incidence and mortality. Recent data have shown that tumors arising from different regions of the colon differ in their molecular characteristics which causes translate into a differential clinical outcome.Several studies described the role of microRNA expression in the initiation and progression of CRC and its response to different therapeutic strategies. Other studies have shown that systemic inflammation is a key determinant role of clinico-pathological outcomes in patients with CRC. We therefore aim to evaluate the expression of selected microRNA and inflammatory markers in patients with stage IV colorectal cancer and assess their correlation with tumor location, dietary patterns, survival rates, response to systemic chemotherapy and other clinic-pathological parameters. We believe that identifying a predictive and prognostic panel made up of circulating microRNA and inflammatory markers may perhaps explain the difference in outcome between right and left colon and perhaps impact the clinical practice in patients with stage IV colorectal cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer Patients | – | –Newly diagnosed stage IV colorectal cancer patients |
| Controls | – | –cancer free |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary physicians will identify patients who are treatment naïve, stage IV colorectal cancer patients, and exclude the patients, who have a history of an inflammatory bowel disease, or an active systemic autoimmune disease, and who have a chronic / recent use of corticosteroids or on immunosuppressant drugs therapy. Recruitment will be done for patients admitted to the chemotherapy infusion unit at the Naef K. Basile Cancer Institution at the American University of Beirut Medical Center.
Key inclusion criteria (3 listed)
- Newly diagnosed Stage IV colorectal cancer
- Treatment naïve
- For the control group: adult individuals (above 18 years) with no cancer disease
Key exclusion criteria (5 listed)
- Any disease or condition that may alter the inflammatory and immune status of subjects at baseline, such as:
- Diagnosis of inflammatory bowel disease such as ulcerative colitis and crohn's disease.
- Diagnosis of active systemic autoimmune disease
- Chronic / recent use of corticosteroids
- Use of immunosuppressant drugs
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
Level of inflammatory markers
Time frame: At diagnosis before chemotherapy
Level of C-reactive protein (CRP), Erythrocyte sedimentation rate (ESR), serum albumin, fibrinogen, haptoglobin, lymphocyte monocyte ratio (LMR), neutrophil lymphocyte ratio (NLR) and platelets lymphocytes ratio (PLR)
microRNA expression Level
Time frame: At diagnosis before chemotherapy
miR-21, miR-19a, miR-155, miR-200c, miR-210, miR-126, miR-345, miR-31, miR-29a, miR-200b, and miR-203
1 secondary outcome
Dietary pattern
Time frame: At diagnosis before chemotherapy and every 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
Related trials for Colorectal Cancer Stage IV
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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.
Sally Temraz, MD principal investigator
American University of Beirut Medical Center
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 Stage IV, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 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: status not confirmed, as of the sponsor's last update on 31 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 Lebanon. 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?
Level of inflammatory markers (time frame: At diagnosis before chemotherapy). 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?
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 31 Jul 2024.