Clinical trial NCT05850559: Assessment of the Diagnostic Role of Serum Insulin-like Growth Factor Binding Protein-3 as a Potential Biomarker for Colorectal Cancer (CRC) in Egypt
Official title: Assessment of the Diagnostic Role of Serum Insulin-like Growth Factor Binding Protein-3 as a Potential Biomarker for Colorectal Cancer (CRC) in Egypt
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colorectal Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A calculated minimum sample of 50 patients diagnosed with Colorectal cancer and 30 apparently healthy subject with matched age and sex as acontrol group.

Brief summary: 1. evaluation of diagnostic importance of insulin like growth factor binding protein3 in patient with recently diagnosed as Colorectal cancer
2. correlation between the diagnostic efficacy of insulin like growth factor binding protein 3 with routine marker carcinoembryonic antigen.

Detailed description: Colorectal Cancer is the third most common cancer diagnosed in the USA and the world's fourth most deadly cancer .the incidence and the mortality rate of colorectal cancer has decreased due to effective cancer screening measures.

Besides an ageing population and dietary habits of high-income countries, unfavourable risk factors such as obesity, lack of physical exercise, and smoking increase the risk of colorectal cancer.

The incidence of early-onset colorectal cancer diagnosed in patients under the age of 50 years- has been increasing around the world.

The insulin-like growth factor (IGF) system composed of two ligands, their receptors and regulatory proteins.

IGFBPs regulate the cell cycle, and the function of IGFBPs in transcriptional regulation, DNA damage repair and apoptosis induction suggest that they are closely associated with tumour development, progression, and therapy resistance.

Insulin-like growth factor peptides play important roles in regulating cell growth, cell differentiation, and apoptosis, and have been demonstrated to promote the development of colorectal cancer.

Researchers found that IGFBP3 has the potential to be used as early indicator for colorectal cancer diagnosis.

Moreover, IGFBP3 as a risk factor for carcinogenesis has been demonstrated in many cancers.

IGFBP3 as a tumour suppressor was reported to be down-regulated in some cancers. But some other publications showed its overexpression is associated with poor prognosis for several cancers including pancreatic endocrine neoplasms.

Meanwhile, epidemiological studies indicated that higher circulating IGFBP3 level were an increased risk of breast cancer.

Eligibility criteria: Inclusion Criteria:

1. Patients at South Egypt Cancer institute and diagnosed Colorectal cancer patients
2. Patients not went to surgery

Exclusion Criteria:

1. patients receive any anti-cancer therapy.
2. Patients diagnosed with other concomitante cancer or chronic diseases

Primary outcomes:
measure: Assessment of the Diagnostic Role of Serum Insulin-like Growth Factor Binding Protein-3 as a Potential Biomarker for Colorectal Cancer (CRC) in Egypt
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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citation: Pankaj J, Kumari JR, Kim W, Lee SA. Insulin-like Growth Factor-1, IGF-binding Protein-3, C-peptide and Colorectal Cancer: a Case-control Study. Asian Pac J Cancer Prev. 2015;16(9):3735-40. doi: 10.7314/apjcp.2015.16.9.3735.
citation: Naguib R, Abouegylah M, Sharkawy S, Fayed AA, Naguib H. Evaluation of Serum Levels of Insulin-Like Growth Factor 1 and Insulin-Like Growth Factor-Binding Protein 3 in Patients With Colorectal Cancer: A Case-Control Study. Cureus. 2021 Nov 25;13(11):e19881. doi: 10.7759/cureus.19881. eCollection 2021 Nov.