Evaluation of Serum Tumor Endothelial Marker1 as a Potential Biomarker for Colorectal Cancer Diagnosis and Cancer Progression

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05779553
• Collaborator: (none)
• Enrollment: 90
• Anticipated Duration (Months): 44

Study Details

Study Description

Brief 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 .

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Diagnostic Test: Tumor Endothelial Marker 1 ( TEM1 ) by ELISA kits

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

• Study Type: Observational
• Anticipated Enrollment: 90 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Evaluation of Serum Tumor Endothelial Marker 1 as a Potential Biomarker for Colorectal Cancer Diagnosis and Cancer Progression
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Feb 1, 2026
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
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	Diagnostic Test: Tumor Endothelial Marker 1 ( TEM1 ) by ELISA kits; 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
Group (2) (control group) 40 apparently healthy individuals with matched age and sex are included in this study as a control group for comparison.	Diagnostic Test: Tumor Endothelial Marker 1 ( TEM1 ) by ELISA kits; 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

Outcome Measures

Primary Outcome Measures

1. Tumor endothelial marker 1 in colorectal cancer [baseline]

   measurement level of serumTEM1 in CRC patients by ng/ml using ELISA kits . measurement of serum CEA , CA19-9 levels by ng/ml

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1-newly diagnosed CRC patients.

Exclusion Criteria:

1. chemotherapy

2. radiotherapy

3. surgical treatment

4. heart failure

5. angina

6. liver cirrhosis

7. renal cell carcinoma

8. gastric cancer.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Esraa Emad Abdel Azeem Kamel, Assiut lecturer, Assiut University
• ClinicalTrials.gov Identifier: NCT05779553
• Other Study ID Numbers: HIJHN
• First Posted: Mar 22, 2023
• Last Update Posted: Mar 22, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colorectal Neoplasms; Disease Progression

Study Results

No Results Posted as of Mar 22, 2023