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NCT Number: NCT05779553

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

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 .

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1-newly diagnosed CRC patients.

Exclusion criteria

  • chemotherapy
  • radiotherapy
  • surgical treatment
  • heart failure
  • angina
  • liver cirrhosis
  • renal cell carcinoma
  • gastric cancer.

Treatment and study plan

Tumor Endothelial Marker 1 ( TEM1 ) by ELISA kits

Diagnostic 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

Primary outcomes

  1. Tumor endothelial marker 1 in colorectal cancer

    Time frame: baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Esraa Emad Abdel Azeem Kamel, master

CONTACT

[email protected]

01067089314

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Evaluation of Serum Tumor Endothelial Marker 1 as a Potential Biomarker for Colorectal Cancer Diagnosis and Cancer Progression

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 22, 2023
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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