NCT03467308

Brief Summary

Colorectal cancer (CRC) is the third most commonly diagnosed cancer and the second leading cause of cancer-related death worldwide. In Egypt, CRC constitutes 4.2% of all cancers with median age is 50 years old.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

May 11, 2020

Status Verified

May 1, 2020

Enrollment Period

1.8 years

First QC Date

February 20, 2018

Last Update Submit

May 7, 2020

Conditions

Colorectal Cancer

Keywords

colorectal cancerTIGARTRIM59

Outcome Measures

Primary Outcomes (2)

  • Measure TIGAR in the study groups.

    Measure TIGAR expression in colorectal cancer patients and risky group patients.

    1 YEAR

  • Measure TRIM59 in the study groups.

    Measure TRIM59 expression in colorectal cancer patients and risky group patients.

    1Year

Secondary Outcomes (1)

  • Targeting new prognostic and therapeutic markers for colorectal cancer.

    1 year

Study Arms (2)

Colorectal cancer patients

50 Patients confirmed histopathologically to have early stages of colorectal cancer.

Genetic: Markers in tissue samples: (TIGAR , TRIM59, P53, AKT, GSH)

Risky group

20 risky patients (those with ulcerative colitis, chron's disease, familial adenomatous polyposis).

Genetic: Markers in tissue samples: (TIGAR , TRIM59, P53, AKT, GSH)

Interventions

Markers in tissue samples: (TIGAR , TRIM59, P53, AKT, GSH)GENETIC

The followings markers will be investigated in tissue samples: 1. TIGAR expression using quantitative real-time polymerase chain reaction (q Rt PCR) and immunohistochemistry. 2. TRIM59 expression using quantitative real-time polymerase chain reaction (q Rt PCR) and immunohistochemistry. P53 expression using immunohistochemistry. P53 nuclear localization is essential for its normal function in growth inhibition or induction of apoptosis. * Akt expression using western blot. * GSH using chemical methods.

Colorectal cancer patientsRisky group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* All Patients confirmed histopathologically to have early stages of colorectal cancer admitted to General Surgery Department -Assiut University Hospital for CRC resection. * Risky group patients (including those with ulcerative colitis, chron's disease, familial adenomatous polyposis) undergoing diagnostic colonoscopy.

You may qualify if:

  • All Patients confirmed histopathologically to have early stages of colorectal cancer.
  • Risky group patients (including those with ulcerative colitis, chron's disease, familial adenomatous polyposis).

You may not qualify if:

  • Patients with previous history of CRC treated with chemotherapy or presence of other types of cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University- faculty of medicine -Medical biochemistry department

Asyut, 71111, Egypt

Location

Related Publications (9)

  • Yang J, Wen J, Tian T, Lu Z, Wang Y, Wang Z, Wang X, Yang Y. GLUT-1 overexpression as an unfavorable prognostic biomarker in patients with colorectal cancer. Oncotarget. 2017 Feb 14;8(7):11788-11796. doi: 10.18632/oncotarget.14352.

    PMID: 28052033BACKGROUND

  • Cheung EC, Athineos D, Lee P, Ridgway RA, Lambie W, Nixon C, Strathdee D, Blyth K, Sansom OJ, Vousden KH. TIGAR is required for efficient intestinal regeneration and tumorigenesis. Dev Cell. 2013 Jun 10;25(5):463-77. doi: 10.1016/j.devcel.2013.05.001. Epub 2013 May 30.

    PMID: 23726973BACKGROUND

  • Won KY, Lim SJ, Kim GY, Kim YW, Han SA, Song JY, Lee DK. Regulatory role of p53 in cancer metabolism via SCO2 and TIGAR in human breast cancer. Hum Pathol. 2012 Feb;43(2):221-8. doi: 10.1016/j.humpath.2011.04.021. Epub 2011 Aug 4.

    PMID: 21820150BACKGROUND

  • Zhao M, Fan J, Liu Y, Yu Y, Xu J, Wen Q, Zhang J, Fu S, Wang B, Xiang L, Feng J, Wu J, Yang L. Oncogenic role of the TP53-induced glycolysis and apoptosis regulator in nasopharyngeal carcinoma through NF-kappaB pathway modulation. Int J Oncol. 2016 Feb;48(2):756-64. doi: 10.3892/ijo.2015.3297. Epub 2015 Dec 17.

    PMID: 26691054BACKGROUND

  • Zhou Z, Ji Z, Wang Y, Li J, Cao H, Zhu HH, Gao WQ. TRIM59 is up-regulated in gastric tumors, promoting ubiquitination and degradation of p53. Gastroenterology. 2014 Nov;147(5):1043-54. doi: 10.1053/j.gastro.2014.07.021. Epub 2014 Jul 18.

    PMID: 25046164BACKGROUND

  • Liang J, Xing D, Li Z, Shen J, Zhao H, Li S. TRIM59 is upregulated and promotes cell proliferation and migration in human osteosarcoma. Mol Med Rep. 2016 Jun;13(6):5200-6. doi: 10.3892/mmr.2016.5183. Epub 2016 Apr 25.

    PMID: 27121462BACKGROUND

  • Zhan W, Han T, Zhang C, Xie C, Gan M, Deng K, Fu M, Wang JB. TRIM59 Promotes the Proliferation and Migration of Non-Small Cell Lung Cancer Cells by Upregulating Cell Cycle Related Proteins. PLoS One. 2015 Nov 24;10(11):e0142596. doi: 10.1371/journal.pone.0142596. eCollection 2015.

    PMID: 26599082BACKGROUND

  • Sun Y, Ji B, Feng Y, Zhang Y, Ji D, Zhu C, Wang S, Zhang C, Zhang D, Sun Y. TRIM59 facilitates the proliferation of colorectal cancer and promotes metastasis via the PI3K/AKT pathway. Oncol Rep. 2017 Jul;38(1):43-52. doi: 10.3892/or.2017.5654. Epub 2017 May 22.

    PMID: 28534983BACKGROUND

  • Ahmad R, Alam M, Hasegawa M, Uchida Y, Al-Obaid O, Kharbanda S, Kufe D. Targeting MUC1-C inhibits the AKT-S6K1-elF4A pathway regulating TIGAR translation in colorectal cancer. Mol Cancer. 2017 Feb 2;16(1):33. doi: 10.1186/s12943-017-0608-9.

    PMID: 28153010BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissue samples and normal intestinal tissue samples from the safety margin around the tumor

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Genes, p53Glutathione

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Genes, Tumor SuppressorGenes, NeoplasmGenesGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGenes, RecessiveOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Asmaa Alaaeldeen Kamal, MD (PhD student)

    Assiut University

    PRINCIPAL INVESTIGATOR

  • Ragaa Hamdy Salama, Professor (MD)

    Assiut University

    STUDY DIRECTOR

  • Maha Ali Essam al-Din, lecturer (MD)

    Assiut University

    STUDY DIRECTOR

  • Marwa AbdelHafiz Abdel Hassan, lecturer (MD)

    Assiut University

    STUDY DIRECTOR

  • Ahmed Ali Abdel Motelb, lecturer (MD)

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2018

First Posted

March 16, 2018

Study Start

March 1, 2018

Primary Completion

January 1, 2020

Study Completion

April 1, 2020

Last Updated

May 11, 2020

Record last verified: 2020-05

Locations

EG(1)