Colorectal CancerNCT05779553
Evaluation of Serum Tumor Endothelial Marker1 as a Potential Biomarker for Colorectal Cancer Diagnosis and Cancer Progression
An observational study of Colorectal Cancer, run by Assiut University.
Trial summary
Aim of work 1. measurement level of serumTEM1 in CRC patients by ng/ml using ELISA kits . 2. find relation between serum TEM1 level and staging of CRC patients . 3. measurement of serum CEA , CA19-9 levels by ng/ml so we can can compare their levels with serum TEM1 level in CRC patients . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Tumor Endothelial Marker 1 ( TEM1 ) by ELISA kits
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: * Fifty patients who were diagnosed by (lower endoscopy, multislice CT abdomen or histopathology analysis of the lesion), tumor staging was classified according to the American Joint Committee on Cancer Staging,TNM staging classification. * Patients did not receive any chemotherapy or undergo surgical treatment * Forty apparently healthy individuals with matched age and sex are included in this study as a control group for comparison
Who may be able to join
- 1-newly diagnosed CRC patients.
Who cannot join
- chemotherapy
- radiotherapy
- surgical treatment
- heart failure
- angina
- liver cirrhosis
- renal cell carcinoma
- gastric cancer.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Serum Tumor Endothelial Marker 1 as a Potential Biomarker for Colorectal Cancer Diagnosis and Cancer Progression
Aim of work
- measurement level of serumTEM1 in CRC patients by ng/ml using ELISA kits .
- find relation between serum TEM1 level and staging of CRC patients .
- measurement of serum CEA , CA19-9 levels by ng/ml so we can can compare their levels with serum TEM1 level in CRC patients .
Read the detailed description
Colorectal cancer (CRC) is a serious health problem, a challenge for research, and a model for studying the molecular mechanisms involved in its development. Colorectal cancer is the third most common cancer in the world with approximately 1.4 million new cases and almost 700,000 associated deaths reported per year. The incidence, morbidity, and mortality rates of CRC are expected to increase due to population aging and profound adverse effects of many life style-related factors.
Tumor growth is dependent on the complex and multistage angiogenesis. Tumor blood vessels are characterized with abnormal morphology and function compared to normal blood vessels. Except for disorganized structure, abnormal basement membrane, and increased leakiness, tumor vascular cells express unique protein named (Tumor endothelial marker 1 (TEM1)- endothialin-CD248) .
Tumor endothelial marker is a transmembrane glycoprotein which expression is significantly higher in tumor vasculature (5-,10-, and 20-fold) compared to the vessels of healthy tissues. It was suggested TEMs could discriminate between tumor and nontumor vascular cells.
Tissue overexpression of TEM1 was found in patients with CRC compared to healthy controls as well as in rectal cancer tissues when comparing tumor, lymph nodes, metastasis (TNM) stage I with other stages: TNM II, III, IV , Although the biology of TEM1 is intensely studied, including clinical studies with anti-TEM1 molecules, Only one study (2020) determined the potential usefulness of serum TEM1 in CRC. Pietrzyk (2020) revealed that TEM1 demonstrated higher levels in the serum of the patients with CRC than healthy individuals and reported that TEM1 could act as a potential diagnostic, progression, and prognostic serum biomarker for patients with CRC. Most commonly used serum markers for diagnosis and monitoring of CRC are carcinoembryonic antigen (CEA) and carbohydrate antigen 19-9 (Ca 19-9). However, these markers show insufficient sensitivity, especially at early stages of CRC. Therefore, finding sensitive and specific, noninvasive, serum biomarkers is a prerequisite for early CRC diagnosis.
- Conditions
- Colorectal Cancer
- Being tested
- Tumor Endothelial Marker 1 ( TEM1 ) by ELISA kits
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Endothelial Marker 1 ( TEM1 ) by ELISA kitsDiagnostic test
measurement of serum TEM1 in CRC patients, its relation to staging and comparing the diagnostic performance of serum TEM1 with serum CEA and CA19-9 for diagnosis of CRC. and Early detection of CRC patient
| Study group | Role | What they receive |
|---|---|---|
| Group (1)(patient group): | who are 50 newly diagnosed patient with colorectal cancer, who will be admitted at South Egypt Cancer Inistitute and Assiut University Hospital during 2023.
Patients group will be furtherly subclassified according to the American Joint Committee on Cancer Staging,TNM staging classification Receives: Diagnostic Test: Tumor Endothelial Marker 1 ( TEM1 ) by ELISA kits | |
| Group (2) (control group) | 40 apparently healthy individuals with matched age and sex are included in this study as a control group for comparison. Receives: Diagnostic Test: Tumor Endothelial Marker 1 ( TEM1 ) by ELISA kits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor endothelial marker 1 in colorectal cancer
- measurement level of serumTEM1 in CRC patients by ng/ml using ELISA kits .
- measurement of serum CEA , CA19-9 levels by ng/ml
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Emad Abdel Azeem Kamel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779553
- Sponsor's protocol ID
- HIJHN
- Status last verified
- Mar 2023
- First submitted
- 14 Jan 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Tumor Endothelial Marker 1 as a Potential Biomarker for Colorectal Cancer Diagnosis and Cancer Progression
- ClinicalTrials.gov ID
- NCT05779553
- Acronym / sponsor ID
- HIJHN
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Mar 2023 (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.
Aim of work
- measurement level of serumTEM1 in CRC patients by ng/ml using ELISA kits .
- find relation between serum TEM1 level and staging of CRC patients .
- measurement of serum CEA , CA19-9 levels by ng/ml so we can can compare their levels with serum TEM1 level in CRC patients .
Detailed description
Colorectal cancer (CRC) is a serious health problem, a challenge for research, and a model for studying the molecular mechanisms involved in its development. Colorectal cancer is the third most common cancer in the world with approximately 1.4 million new cases and almost 700,000 associated deaths reported per year. The incidence, morbidity, and mortality rates of CRC are expected to increase due to population aging and profound adverse effects of many life style-related factors.
Tumor growth is dependent on the complex and multistage angiogenesis. Tumor blood vessels are characterized with abnormal morphology and function compared to normal blood vessels. Except for disorganized structure, abnormal basement membrane, and increased leakiness, tumor vascular cells express unique protein named (Tumor endothelial marker 1 (TEM1)- endothialin-CD248) .
Tumor endothelial marker is a transmembrane glycoprotein which expression is significantly higher in tumor vasculature (5-,10-, and 20-fold) compared to the vessels of healthy tissues. It was suggested TEMs could discriminate between tumor and nontumor vascular cells.
Tissue overexpression of TEM1 was found in patients with CRC compared to healthy controls as well as in rectal cancer tissues when comparing tumor, lymph nodes, metastasis (TNM) stage I with other stages: TNM II, III, IV , Although the biology of TEM1 is intensely studied, including clinical studies with anti-TEM1 molecules, Only one study (2020) determined the potential usefulness of serum TEM1 in CRC. Pietrzyk (2020) revealed that TEM1 demonstrated higher levels in the serum of the patients with CRC than healthy individuals and reported that TEM1 could act as a potential diagnostic, progression, and prognostic serum biomarker for patients with CRC. Most commonly used serum markers for diagnosis and monitoring of CRC are carcinoembryonic antigen (CEA) and carbohydrate antigen 19-9 (Ca 19-9). However, these markers show insufficient sensitivity, especially at early stages of CRC. Therefore, finding sensitive and specific, noninvasive, serum biomarkers is a prerequisite for early CRC diagnosis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (1)(patient group): | – | Diagnostic Test: Tumor Endothelial Marker 1 ( TEM1 ) by ELISA kitswho are 50 newly diagnosed patient with colorectal cancer, who will be admitted at South Egypt Cancer Inistitute and Assiut University Hospital during 2023. Patients group will be furtherly subclassified according to the American Joint Committee on Cancer Staging,TNM staging classification |
| Group (2) (control group) | – | Diagnostic Test: Tumor Endothelial Marker 1 ( TEM1 ) by ELISA kits40 apparently healthy individuals with matched age and sex are included in this study as a control group for comparison. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Fifty patients who were diagnosed by (lower endoscopy, multislice CT abdomen or histopathology analysis of the lesion), tumor staging was classified according to the American Joint Committee on Cancer Staging,TNM staging classification. * Patients did not receive any chemotherapy or undergo surgical treatment * Forty apparently healthy individuals with matched age and sex are included in this study as a control group for comparison
Key inclusion criteria (1 listed)
- 1-newly diagnosed CRC patients.
Key exclusion criteria (8 listed)
- chemotherapy
- radiotherapy
- surgical treatment
- heart failure
- angina
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 |
|---|---|---|
| Tumor Endothelial Marker 1 ( TEM1 ) by ELISA kitsmeasurement of serum TEM1 in CRC patients, its relation to staging and comparing the diagnostic performance of serum TEM1 with serum CEA and CA19-9 for diagnosis of CRC. and Early detection of CRC patient | Diagnostic test | Group (1)(patient group):, Group (2) (control group) |
Primary outcome
Tumor endothelial marker 1 in colorectal cancer
Time frame: baseline
1. measurement level of serumTEM1 in CRC patients by ng/ml using ELISA kits . 2. measurement of serum CEA , CA19-9 levels by ng/ml
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Assiut University.
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 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: opening soon, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esraa Emad Abdel Azeem Kamel, master (01067089314, esraaemad1995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor endothelial marker 1 in colorectal cancer (time frame: baseline). 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 22 Mar 2023.