Assessment of the Diagnostic Role of Serum Insulin-like Growth Factor Binding Protein-3 as a Potential Biomarker for Colorectal Cancer (CRC) in Egypt

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05850559
• Other study ID #: ELISA and colorectal cancer
• Status: Not yet recruiting
• Start date: October 5, 2023
• Est. completion date: October 1, 2026

Study information

• Verified date: April 2023
• Source: Assiut University
• Contact: Hebat allah Galal Mabady, resident
• Phone: 01069497743
• Email: hebaalah594[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2025
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• evaluation of diagnostic importance of insulin like growth factor binding protein3 in patient with recently diagnosed as Colorectal cancer
evaluation of diagnostic importance of insulin like growth factor binding protein3 in patient with recently diagnosed as Colorectal cancer by Enzyme-linked immunosorbent assay (ELISA

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Murphy N, Carreras-Torres R, Song M, Chan AT, Martin RM, Papadimitriou N, Dimou N, Tsilidis KK, Banbury B, Bradbury KE, Besevic J, Rinaldi S, Riboli E, Cross AJ, Travis RC, Agnoli C, Albanes D, Berndt SI, Bezieau S, Bishop DT, Brenner H, Buchanan DD, Onland-Moret NC, Burnett-Hartman A, Campbell PT, Casey G, Castellvi-Bel S, Chang-Claude J, Chirlaque MD, de la Chapelle A, English D, Figueiredo JC, Gallinger SJ, Giles GG, Gruber SB, Gsur A, Hampe J, Hampel H, Harrison TA, Hoffmeister M, Hsu L, Huang WY, Huyghe JR, Jenkins MA, Keku TO, Kuhn T, Kweon SS, Le Marchand L, Li CI, Li L, Lindblom A, Martin V, Milne RL, Moreno V, Newcomb PA, Offit K, Ogino S, Ose J, Perduca V, Phipps AI, Platz EA, Potter JD, Qu C, Rennert G, Sakoda LC, Schafmayer C, Schoen RE, Slattery ML, Tangen CM, Ulrich CM, van Duijnhoven FJB, Van Guelpen B, Visvanathan K, Vodicka P, Vodickova L, Vymetalkova V, Wang H, White E, Wolk A, Woods MO, Wu AH, Zheng W, Peters U, Gunter MJ. Circulating Levels of Insulin-like Growth Factor 1 and Insulin-like Growth Factor Binding Protein 3 Associate With Risk of Colorectal Cancer Based on Serologic and Mendelian Randomization Analyses. Gastroenterology. 2020 Apr;158(5):1300-1312.e20. doi: 10.1053/j.gastro.2019.12.020. Epub 2019 Dec 27. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the Diagnostic Role of Serum Insulin-like Growth Factor Binding Protein-3 as a Potential Biomarker for Colorectal Cancer (CRC) in Egypt	measure level of insulin like growth factor binding protein3 in serum in patients of egypt recently diagnosed as Colorectal cancer by useing ELISA	Baseline