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

March 20, 2023 updated by: Esraa Emad Abdel Azeem Kamel, Assiut University

Evaluation of Serum Tumor Endothelial Marker 1 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 .

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

February 1, 2026

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

January 14, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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