NCT04729855

Brief Summary

  1. 1.Determination of expression level of HOTTIP and EIF4EBP1(Eukaryotic translation initiation factor 4E-binding protein 1) .
  2. 2.Investigation of the SNP HOTTIP rs1859168 and it's association with CRC susceptibility.
  3. 3.Correlation of the expression of these genes with various stages of CRC to determine the prognostic value of each of them.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

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

January 24, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 15, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2024

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

1.1 years

First QC Date

January 24, 2021

Last Update Submit

April 27, 2025

Conditions

Keywords

Colorectal cancer, HOTTIP

Outcome Measures

Primary Outcomes (1)

  • HOTTIP gene expression

    Estimation of expression level of HOTTIP in peripheral blood mononuclear cells and tissue aiming to use as possible less invasive prognostic markers for colorectal cancer.

    2 years

Secondary Outcomes (1)

  • EIF4EBP

    2 years

Study Arms (2)

colorectal cancer patients

Colorectal cancer patients( n = 30 ) from stage I-III with the following criteria:- a. Inclusion criteria: * No sex predilection. * Age (25-65 yr). * Colorectal carcinoma confirmed by histopathological examination

Diagnostic Test: PBMCs and Tissue expression of HOTTIP ,EIF4EBP1 and serum SNP HOTTIP rs1859168

Healthy controls ( n = 30)

matched as regarding age and sex as much as possible with cases.

Diagnostic Test: PBMCs and Tissue expression of HOTTIP ,EIF4EBP1 and serum SNP HOTTIP rs1859168

Interventions

5 ml fresh blood sample, normal and CRC tissue

Healthy controls ( n = 30)colorectal cancer patients

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy controls ( n = 30) matched as regarding age and sex as much as possible with cases. -Colorectal cancer patients( n = 30 ) from stage I-III with the following criteria:-

You may qualify if:

  • No sex predilection.
  • Age (25-65 yr).
  • Colorectal carcinoma confirmed by histopathological examination

You may not qualify if:

  • patients who received any treatment.
  • Cases with other organ cancers.
  • History of chemotherapy and radiotherapy.
  • Systemic diseases such as renal failure, diabetes mellitus, and hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (14)

  • Chisanga D, Keerthikumar S, Pathan M, Ariyaratne D, Kalra H, Boukouris S, Mathew NA, Al Saffar H, Gangoda L, Ang CS, Sieber OM, Mariadason JM, Dasgupta R, Chilamkurti N, Mathivanan S. Colorectal cancer atlas: An integrative resource for genomic and proteomic annotations from colorectal cancer cell lines and tissues. Nucleic Acids Res. 2016 Jan 4;44(D1):D969-74. doi: 10.1093/nar/gkv1097. Epub 2015 Oct 22.

    PMID: 26496946BACKGROUND
  • Vorobiova OA. [Participation of the supraoptic nucleus of the anterior hypothalamus in controlling the gonadotropic functions of the pituitary]. Fiziol Zh. 1974 May-Jun;20(3):334-8. No abstract available. Ukrainian.

    PMID: 4466671BACKGROUND
  • Katheder NS, Khezri R, O'Farrell F, Schultz SW, Jain A, Rahman MM, Schink KO, Theodossiou TA, Johansen T, Juhasz G, Bilder D, Brech A, Stenmark H, Rusten TE. Microenvironmental autophagy promotes tumour growth. Nature. 2017 Jan 19;541(7637):417-420. doi: 10.1038/nature20815. Epub 2017 Jan 11.

    PMID: 28077876BACKGROUND
  • Rahman MA, Rhim H. Therapeutic implication of autophagy in neurodegenerative diseases. BMB Rep. 2017 Jul;50(7):345-354. doi: 10.5483/bmbrep.2017.50.7.069.

    PMID: 28454606BACKGROUND
  • Uddin MS, Stachowiak A, Mamun AA, Tzvetkov NT, Takeda S, Atanasov AG, Bergantin LB, Abdel-Daim MM, Stankiewicz AM. Autophagy and Alzheimer's Disease: From Molecular Mechanisms to Therapeutic Implications. Front Aging Neurosci. 2018 Jan 30;10:04. doi: 10.3389/fnagi.2018.00004. eCollection 2018.

    PMID: 29441009BACKGROUND
  • Avalos Y, Canales J, Bravo-Sagua R, Criollo A, Lavandero S, Quest AF. Tumor suppression and promotion by autophagy. Biomed Res Int. 2014;2014:603980. doi: 10.1155/2014/603980. Epub 2014 Sep 18.

    PMID: 25328887BACKGROUND
  • Abdullah LN, Chow EK. Mechanisms of chemoresistance in cancer stem cells. Clin Transl Med. 2013 Jan 17;2(1):3. doi: 10.1186/2001-1326-2-3.

    PMID: 23369605BACKGROUND
  • Ojha R, Bhattacharyya S, Singh SK. Autophagy in Cancer Stem Cells: A Potential Link Between Chemoresistance, Recurrence, and Metastasis. Biores Open Access. 2015 Jan 1;4(1):97-108. doi: 10.1089/biores.2014.0035. eCollection 2015.

    PMID: 26309786BACKGROUND
  • Cha YL, Li PD, Yuan LJ, Zhang MY, Zhang YJ, Rao HL, Zhang HZ, Zheng XF, Wang HY. EIF4EBP1 overexpression is associated with poor survival and disease progression in patients with hepatocellular carcinoma. PLoS One. 2015 Feb 6;10(2):e0117493. doi: 10.1371/journal.pone.0117493. eCollection 2015.

    PMID: 25658620BACKGROUND
  • Bonasio R, Shiekhattar R. Regulation of transcription by long noncoding RNAs. Annu Rev Genet. 2014;48:433-55. doi: 10.1146/annurev-genet-120213-092323. Epub 2014 Sep 18.

    PMID: 25251851BACKGROUND
  • Wang KC, Yang YW, Liu B, Sanyal A, Corces-Zimmerman R, Chen Y, Lajoie BR, Protacio A, Flynn RA, Gupta RA, Wysocka J, Lei M, Dekker J, Helms JA, Chang HY. A long noncoding RNA maintains active chromatin to coordinate homeotic gene expression. Nature. 2011 Apr 7;472(7341):120-4. doi: 10.1038/nature09819. Epub 2011 Mar 20.

    PMID: 21423168BACKGROUND
  • Lv Z, Xu Q, Yuan Y. A systematic review and meta-analysis of the association between long non-coding RNA polymorphisms and cancer risk. Mutat Res Rev Mutat Res. 2017 Jan-Mar;771:1-14. doi: 10.1016/j.mrrev.2016.10.002. Epub 2016 Nov 5.

    PMID: 28342449BACKGROUND
  • Hu P, Qiao O, Wang J, Li J, Jin H, Li Z, Jin Y. rs1859168 A > C polymorphism regulates HOTTIP expression and reduces risk of pancreatic cancer in a Chinese population. World J Surg Oncol. 2017 Aug 17;15(1):155. doi: 10.1186/s12957-017-1218-0.

    PMID: 28818070BACKGROUND
  • Shang A, Wang W, Gu C, Chen C, Zeng B, Yang Y, Ji P, Sun J, Wu J, Lu W, Sun Z, Li D. Correction to: Long non-coding RNA HOTTIP enhances IL-6 expression to potentiate immune escape of ovarian cancer cells by upregulating the expression of PD-L1 in neutrophils. J Exp Clin Cancer Res. 2020 Dec 4;39(1):272. doi: 10.1186/s13046-020-01755-z.

    PMID: 33272287BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

EDTA (ethylene diamine tetra acetic acid)coated fresh blood sample

MeSH Terms

Conditions

Colonic NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Esraa H Mohamed, Master

    Assistant lecturer of Medical Microbiology and Immunology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

January 24, 2021

First Posted

January 29, 2021

Study Start

April 15, 2022

Primary Completion

May 20, 2023

Study Completion

September 20, 2024

Last Updated

April 30, 2025

Record last verified: 2025-04

Locations