AzTrials
AzTrials

Colorectal CancerNCT04728139

Assessment of Glypican 3 as Apredictive Marker in Colorectal Cancer Patients

A study testing glypican 3 in people with Colorectal Cancer, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Evaluation Of Glypican 3 in serum of colorectal cancer patients . Correlation between Glypican 3 and clinicopathological characteristics of colorectal cancer . Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Colorectal Cancer
What is being tested?
glypican 3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
Mar 2022to Oct 2024
Phase
Interventional
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Patients with colorectal cancer and admitted to south egypt cancer institute .

Who cannot join

  • Other malignant diseases .
  • Patients received chemotherapy for colorectal cancer .

Trial locations and contacts

No sites are listed yet.

Reham Hany Mohammed contact

01118441744

rehamhany809@gmail.com

Hosney Badrawy Hamed contact

01060664976

BadranH@yahoo.com

About this study

Official title: Assessment of Glypican 3 as a Predictive Marker in Colorectal Cancer Patients

  • Evaluation Of Glypican 3 in serum of colorectal cancer patients .
  • Correlation between Glypican 3 and clinicopathological characteristics of colorectal cancer .
Read the detailed description

Colorectal cancer (CRC) is the third most common malignancy and the fourth most prominent cause of cancer-related deaths worldwide. Also it is the 7th commonest cancer in Egypt, representing 3.47% of male cancers and 3% of female cancers.The Glypicans , a family of proteins classified as HSPGs (heparan sulfate proteoglycan) , have been shown to interact with a number of growth factors and modulate growth factor activity and are linked to the xtracellular side of cell membrane by a glycosylphosphatidylinositol (GPI) anchor . Members of this large family of transmembrane proteins have been identified in both mammals and drosophila: 6 glypicans (GPC-1 through GPC-6) in mammals, and two others in the fly .Glypican-3 (GPC3) as one of this family is a protein of about 70 kD . It has multiple sugar chains and heparan sulfate modification sites . These proteins (Glypicans) participate in organ development by modulating extracellular growth signals and morphogen gradient formation, and are involved in human overgrowth and skeletal dysplasia problems .In some cancers, they are highly expressed, associated with tumorigenesis, and regulating angiogenesis for cancer progression and invasion . Abnormal expression of glypicans has been noted in multiple types of cancer. For examples, GPC-1 expression was found to be increased in breast cancer tissues and ovarian malignant tumors .GPC-2 is associated with neuroblastoma .Expression of GPC-3 was found in high-grade urothelial carcinoma and also reported in some non-CNS tumors of the brain.There have been several reports about the clinical usefulness of the N-terminal form of GPC3. Enzyme-linked immunosorbent assay methods capable of detecting the N-terminal form of GPC3 . A study of colorectal cancer tissue speciment shows a correlation between expression of GPC3 with the clinicopathologic variables such as the level of differentiation, GPC3 was found to be expressed in ( 42.8% ) of the well-differentiated tumors, and (50%) of the moderately differentiated tumors, (75%) of the moderately and poorly differentiated tumors .Therefore, it was found that the expression of GPC3 was correlated with the pathological grade of the tumors .

Being tested
glypican 3
Keywords
glypican 3
Medical subject headings
Colorectal Neoplasms, Simpson-Golabi-Behmel syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • glypican 3Diagnostic test

    Assessment of glypican 3 presence in colorectal cancer patients using ELISA

Study groups in NCT04728139
Study groupRoleWhat they receive
patients with colorecta cancerActive comparatorNot described
Receives: Diagnostic Test: glypican 3
healthy individualsNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of Glypican 3 role as a predictive and diagnostic marker of colorectal marker .

    measurment of GLYPICAN 3 level in serum of colorectal patients using ELISA method

    Measured: 3 years

Secondary outcomes (1)

  1. Addition of Glypican 3 to the routine markers of colorectal cancer . - Correlatin of this marker with the disease pathology and management procedures .

    measurment of GLYPICAN 3 level in serum of colorectal patients using ELISA method

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2021
  2. Study startMar 2022 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionOct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04728139
Sponsor's protocol ID
colorectal cancer
Status last verified
Jan 2022
First submitted
13 Sep 2020
Last updated
13 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Terzic J, Grivennikov S, Karin E, Karin M. Inflammation and colon cancer. Gastroenterology. 2010 Jun;138(6):2101-2114.e5. doi: 10.1053/j.gastro.2010.01.058.

    PubMed 20420949

  • Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.

    PubMed 25328522

  • Ijaz B, Formentin E, Ronci B, Locato V, Barizza E, Hyder MZ, Lo Schiavo F, Yasmin T. Salt tolerance in indica rice cell cultures depends on a fine tuning of ROS signalling and homeostasis. PLoS One. 2019 Apr 30;14(4):e0213986. doi: 10.1371/journal.pone.0213986. eCollection 2019.

    PubMed 31039145

  • Filmus J, Selleck SB. Glypicans: proteoglycans with a surprise. J Clin Invest. 2001 Aug;108(4):497-501. doi: 10.1172/JCI13712. No abstract available.

    PubMed 11518720

  • Shirakawa H, Kuronuma T, Nishimura Y, Hasebe T, Nakano M, Gotohda N, Takahashi S, Nakagohri T, Konishi M, Kobayashi N, Kinoshita T, Nakatsura T. Glypican-3 is a useful diagnostic marker for a component of hepatocellular carcinoma in human liver cancer. Int J Oncol. 2009 Mar;34(3):649-56. doi: 10.3892/ijo_00000190.

    PubMed 19212669

  • Sarrazin S, Lamanna WC, Esko JD. Heparan sulfate proteoglycans. Cold Spring Harb Perspect Biol. 2011 Jul 1;3(7):a004952. doi: 10.1101/cshperspect.a004952.

    PubMed 21690215

  • Fico A, Maina F, Dono R. Fine-tuning of cell signaling by glypicans. Cell Mol Life Sci. 2011 Mar;68(6):923-9. doi: 10.1007/s00018-007-7471-6. Epub 2011 Feb 22.

    PubMed 18087675

  • Matsuda K, Maruyama H, Guo F, Kleeff J, Itakura J, Matsumoto Y, Lander AD, Korc M. Glypican-1 is overexpressed in human breast cancer and modulates the mitogenic effects of multiple heparin-binding growth factors in breast cancer cells. Cancer Res. 2001 Jul 15;61(14):5562-9.

    PubMed 11454708

  • Davies EJ, Blackhall FH, Shanks JH, David G, McGown AT, Swindell R, Slade RJ, Martin-Hirsch P, Gallagher JT, Jayson GC. Distribution and clinical significance of heparan sulfate proteoglycans in ovarian cancer. Clin Cancer Res. 2004 Aug 1;10(15):5178-86. doi: 10.1158/1078-0432.CCR-03-0103.

    PubMed 15297422

  • Bosse KR, Raman P, Zhu Z, Lane M, Martinez D, Heitzeneder S, Rathi KS, Kendsersky NM, Randall M, Donovan L, Morrissy S, Sussman RT, Zhelev DV, Feng Y, Wang Y, Hwang J, Lopez G, Harenza JL, Wei JS, Pawel B, Bhatti T, Santi M, Ganguly A, Khan J, Marra MA, Taylor MD, Dimitrov DS, Mackall CL, Maris JM. Identification of GPC2 as an Oncoprotein and Candidate Immunotherapeutic Target in High-Risk Neuroblastoma. Cancer Cell. 2017 Sep 11;32(3):295-309.e12. doi: 10.1016/j.ccell.2017.08.003.

    PubMed 28898695

  • Aleksikova RIa. [On the morbidity of school-children in senior classes of Leningrad boarding schools]. Zdravookhr Ross Fed. 1965 Nov;9(11):11-3. No abstract available. Russian.

    PubMed 4225756

  • Chan ES, Pawel BR, Corao DA, Venneti S, Russo P, Santi M, Sullivan LM. Immunohistochemical expression of glypican-3 in pediatric tumors: an analysis of 414 cases. Pediatr Dev Pathol. 2013 Jul-Aug;16(4):272-7. doi: 10.2350/12-06-1216-OA.1. Epub 2013 Mar 26.

    PubMed 23530909

  • Haruyama Y, Yorita K, Yamaguchi T, Kitajima S, Amano J, Ohtomo T, Ohno A, Kondo K, Kataoka H. High preoperative levels of serum glypican-3 containing N-terminal subunit are associated with poor prognosis in patients with hepatocellular carcinoma after partial hepatectomy. Int J Cancer. 2015 Oct 1;137(7):1643-51. doi: 10.1002/ijc.29518. Epub 2015 Apr 6.

    PubMed 25784484

Questions about this trial

What is this clinical trial studying?

A study testing glypican 3 in people with 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 1 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 13 Jan 2022. 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 Reham Hany Mohammed (01118441744, rehamhany809@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Glypican 3 role as a predictive and diagnostic marker of colorectal marker . (time frame: 3 years). 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 NCT04728139, which also lists 13 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 13 Jan 2022.

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