Colorectal CancerNCT05850559
Assessment of the Diagnostic Role of Serum Insulin-like Growth Factor Binding Protein-3 as a Potential Biomarker for Colorectal Cancer (CRC) in Egypt
An observational study of Colorectal Cancer, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- evaluation of diagnostic importance of insulin like growth factor binding protein3 in patient with recently diagnosed as Colorectal cancer
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2023to 1 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Patients at South Egypt Cancer institute and diagnosed Colorectal cancer patients
- Patients not went to surgery
Who cannot join
- patients receive any anti-cancer therapy.
- Patients diagnosed with other concomitante cancer or chronic diseases
Trial locations and contacts
No sites are listed yet.
About this study
- evaluation of diagnostic importance of insulin like growth factor binding protein3 in patient with recently diagnosed as Colorectal cancer
- correlation between the diagnostic efficacy of insulin like growth factor binding protein 3 with routine marker carcinoembryonic antigen.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- evaluation of diagnostic importance of insulin like growth factor binding protein3 in patient with recently diagnosed as Colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of diagnostic importance of insulin like growth factor binding protein3 in patient with recently diagnosed as Colorectal cancerDiagnostic test
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start5 Oct 2023 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebat Allah Galal Eldin Mabady, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850559
- Sponsor's protocol ID
- ELISA and colorectal cancer
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31884074Pankaj 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.
PubMed 25987030Naguib 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.
PubMed 34858769
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05850559
- Acronym / sponsor ID
- ELISA and colorectal cancer
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- evaluation of diagnostic importance of insulin like growth factor binding protein3 in patient with recently diagnosed as Colorectal cancer
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients at South Egypt Cancer institute and diagnosed Colorectal cancer patients
- Patients not went to surgery
Key exclusion criteria (2 listed)
- patients receive any anti-cancer therapy.
- Patients diagnosed with other concomitante cancer or chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluation of diagnostic importance of insulin like growth factor binding protein3 in patient with recently diagnosed as Colorectal cancerevaluation of diagnostic importance of insulin like growth factor binding protein3 in patient with recently diagnosed as Colorectal cancer by Enzyme-linked immunosorbent assay (ELISA | Diagnostic test | – |
Primary outcome
Assessment of the Diagnostic Role of Serum Insulin-like Growth Factor Binding Protein-3 as a Potential Biomarker for Colorectal Cancer (CRC) in Egypt
Time frame: Baseline
measure level of insulin like growth factor binding protein3 in serum in patients of egypt recently diagnosed as Colorectal cancer by useing ELISA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 31884074Murphy 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.
- Background: PubMed 25987030Pankaj 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.
- Background: PubMed 34858769Naguib 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hebat allah Galal Mabady, resident (01069497743, hebaalah594@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05850559, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.