Colo-rectal CancerNCT04729855
Association of Autophagy-related Genes ,LncRNA and SNPs With Colorectal Cancer in Egyptian Population
An observational study of Colo-rectal Cancer, run by Esraa Hassan,MD at 1 site in Egypt.
Trial summary
1. Determination of expression level of HOTTIP and EIF4EBP1(Eukaryotic translation initiation factor 4E-binding protein 1) . 2. Investigation of the SNP HOTTIP rs1859168 and it's association with CRC susceptibility. 3. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- PBMCs and Tissue expression of HOTTIP ,EIF4EBP1 and serum SNP HOTTIP rs1859168
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2022to 20 Sep 2024
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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:-
Who may be able to join
- No sex predilection.
- Age (25-65 yr).
- Colorectal carcinoma confirmed by histopathological examination
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country.
About this study
- Determination of expression level of HOTTIP and EIF4EBP1(Eukaryotic translation initiation factor 4E-binding protein 1) .
- Investigation of the SNP HOTTIP rs1859168 and it's association with CRC susceptibility.
- Correlation of the expression of these genes with various stages of CRC to determine the prognostic value of each of them.
Read the detailed description
Colorectal cancer (CRC) is a common digestive tract tumor 1.It is the third leading cause of death in the world. Overall 5-year survival rate is less than 40%, and the occurrence is rising 2. However, the prognosis and therapy have not been significantly improved. Therefore, a proper selection of patients for aggressive treatment is necessary, new therapeutic and prognostic strategies are urgently needed 3.
Autophagy is a pathway for self-digestion, in which unwanted cytoplasmic components are recycled 4.In normal conditions, autophagy is essential for cellular homeostasis 5. Autophagy has dual roles in cancer cells, stimulation or suppression , with effects on progression and oncogenesis 6.Recent research established that autophagy is important target for controlling cancer depending on stage and type of tumor 7.Diverse molecular mechanisms contribute to cancer cells resistance to treatment 8.Among these mechanisms , autophagy appears to be critical 9.
EIF4EBP1 (Eukaryotic translation initiation factor 4E-binding protein 1) is encoded by EIF4EBP1 gene.It acts as an effector in mTOR (mammilian target of rapamycin) pathway which on activation ,EIF4EBP1 is phosphorylated promoting cell proliferation 10. Studies have suggested that EIF4EBP1 promotes carcinogenesis as in hepatocellular carcinoma .However, its role in CRC have not been elucidated 10.
Long non-coding RNAs (lncRNAs) are group of RNA , 200 nucleotides in length 11,. Expression of lncRNAs has been discovered in multiple tumors, acting as oncogenes. 'HOXA(hydrogenase transcriptional regulatory protein) transcript at the distal tip' (HOTTIP) has received attention lately.It is up-regulated in CRC tissue, regulating genes via epigenetic modification. Therefore, it might be a candidate for cancerization and therapy of CRC 12.
Expression of lncRNAs could be affected by single nucleotide polymorphisms (SNPs), the most common genetic variation in human genomes13. rs1859168 was reported as a potential functional polymorphism on HOTTIP that alters its expression level 14.. Also, it was recently reported that HOTTIP enhances interleukin 6 expression, which potentiates immune escape of cancer cells 15.
- Conditions
- Colo-rectal Cancer
- Being tested
- PBMCs and Tissue expression of HOTTIP ,EIF4EBP1 and serum SNP HOTTIP rs1859168
- Keywords
- Colorectal cancer, HOTTIP
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBMCs and Tissue expression of HOTTIP ,EIF4EBP1 and serum SNP HOTTIP rs1859168Diagnostic test
5 ml fresh blood sample, normal and CRC tissue
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Diagnostic Test: PBMCs and Tissue expression of HOTTIP ,EIF4EBP1 and serum SNP HOTTIP rs1859168 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
EIF4EBP
Estimation of expression level of EIF4EBP in peripheral blood mononuclear cells and tissue
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start15 Apr 2022
- Primary completion20 May 2023
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esraa Hassan,MD
- Sponsor type
- University, hospital or other
- Collaborators
- South Egypt Cancer Institute
- Responsible party
- Sponsor-investigator, Esraa Hassan,MD, Assiut University
- Investigators
- Esraa H Mohamed, Master, Principal investigator, Assistant lecturer of Medical Microbiology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729855
- Sponsor's protocol ID
- Esraa Hassan MD Protocol
- Status last verified
- Apr 2025
- First submitted
- 24 Jan 2021
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: all researchers will have access to individual patient data with preserving confidentiality
Publications
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.
PubMed 26496946Yang M, Zhao H, Guo L, Zhang Q, Zhao L, Bai S, Zhang M, Xu S, Wang F, Wang X, Zhao B. Autophagy-based survival prognosis in human colorectal carcinoma. Oncotarget. 2015 Mar 30;6(9):7084-103. doi: 10.18632/oncotarget.3054.
PubMed 25762626Katheder 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.
PubMed 28077876Rahman 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.
PubMed 28454606Uddin 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.
PubMed 29441009Avalos 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.
PubMed 25328887Abdullah 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.
PubMed 23369605Ojha 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.
PubMed 26309786Cha 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.
PubMed 25658620Bonasio 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.
PubMed 25251851Wang 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.
PubMed 21423168Lv 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.
PubMed 28342449Hu 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.
PubMed 28818070Shang 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.
PubMed 33272287
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Autophagy-related Genes ,LncRNA and SNPs With Colorectal Cancer in Egyptian Population
- ClinicalTrials.gov ID
- NCT04729855
- Acronym / sponsor ID
- Esraa Hassan MD Protocol
- Conditions
- Colo-rectal Cancer
- Keywords
- Colorectal cancer, HOTTIP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Esraa Hassan,MDUniversity, hospital or other
- Collaborators
- South Egypt Cancer Institute
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 29 Jan 2021 (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.
- Determination of expression level of HOTTIP and EIF4EBP1(Eukaryotic translation initiation factor 4E-binding protein 1) .
- Investigation of the SNP HOTTIP rs1859168 and it's association with CRC susceptibility.
- Correlation of the expression of these genes with various stages of CRC to determine the prognostic value of each of them.
Detailed description
Colorectal cancer (CRC) is a common digestive tract tumor 1.It is the third leading cause of death in the world. Overall 5-year survival rate is less than 40%, and the occurrence is rising 2. However, the prognosis and therapy have not been significantly improved. Therefore, a proper selection of patients for aggressive treatment is necessary, new therapeutic and prognostic strategies are urgently needed 3.
Autophagy is a pathway for self-digestion, in which unwanted cytoplasmic components are recycled 4.In normal conditions, autophagy is essential for cellular homeostasis 5. Autophagy has dual roles in cancer cells, stimulation or suppression , with effects on progression and oncogenesis 6.Recent research established that autophagy is important target for controlling cancer depending on stage and type of tumor 7.Diverse molecular mechanisms contribute to cancer cells resistance to treatment 8.Among these mechanisms , autophagy appears to be critical 9.
EIF4EBP1 (Eukaryotic translation initiation factor 4E-binding protein 1) is encoded by EIF4EBP1 gene.It acts as an effector in mTOR (mammilian target of rapamycin) pathway which on activation ,EIF4EBP1 is phosphorylated promoting cell proliferation 10. Studies have suggested that EIF4EBP1 promotes carcinogenesis as in hepatocellular carcinoma .However, its role in CRC have not been elucidated 10.
Long non-coding RNAs (lncRNAs) are group of RNA , 200 nucleotides in length 11,. Expression of lncRNAs has been discovered in multiple tumors, acting as oncogenes. 'HOXA(hydrogenase transcriptional regulatory protein) transcript at the distal tip' (HOTTIP) has received attention lately.It is up-regulated in CRC tissue, regulating genes via epigenetic modification. Therefore, it might be a candidate for cancerization and therapy of CRC 12.
Expression of lncRNAs could be affected by single nucleotide polymorphisms (SNPs), the most common genetic variation in human genomes13. rs1859168 was reported as a potential functional polymorphism on HOTTIP that alters its expression level 14.. Also, it was recently reported that HOTTIP enhances interleukin 6 expression, which potentiates immune escape of cancer cells 15.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colorectal cancer patients | – | Diagnostic Test: PBMCs and Tissue expression of HOTTIP ,EIF4EBP1 and serum SNP HOTTIP rs1859168Colorectal 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 |
| Healthy controls ( n = 30) | – | Diagnostic Test: PBMCs and Tissue expression of HOTTIP ,EIF4EBP1 and serum SNP HOTTIP rs1859168matched as regarding age and sex as much as possible with cases. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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:-
Key inclusion criteria (3 listed)
- No sex predilection.
- Age (25-65 yr).
- Colorectal carcinoma confirmed by histopathological examination
Key exclusion criteria (4 listed)
- -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.
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 |
|---|---|---|
| PBMCs and Tissue expression of HOTTIP ,EIF4EBP1 and serum SNP HOTTIP rs18591685 ml fresh blood sample, normal and CRC tissue | Diagnostic test | Healthy controls ( n = 30), colorectal cancer patients |
Primary outcome
HOTTIP gene expression
Time frame: 2 years
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.
1 secondary outcome
EIF4EBP
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Background: PubMed 26496946Chisanga 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.
- Background: PubMed 25762626Yang M, Zhao H, Guo L, Zhang Q, Zhao L, Bai S, Zhang M, Xu S, Wang F, Wang X, Zhao B. Autophagy-based survival prognosis in human colorectal carcinoma. Oncotarget. 2015 Mar 30;6(9):7084-103. doi: 10.18632/oncotarget.3054.
- Background: PubMed 28077876Katheder 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.
- Background: PubMed 28454606Rahman 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.
- Background: PubMed 29441009Uddin 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.
- Background: PubMed 25328887Avalos 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.
- Background: PubMed 23369605Abdullah 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.
- Background: PubMed 26309786Ojha 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.
- Background: PubMed 25658620Cha 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.
- Background: PubMed 25251851Bonasio 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.
- Background: PubMed 21423168Wang 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.
- Background: PubMed 28342449Lv 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.
- Individual participant dataSharing planned: Undecided. all researchers will have access to individual patient data with preserving confidentiality
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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.
Esraa H Mohamed, Master principal investigator
Assistant lecturer of Medical Microbiology and Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer, run by Esraa Hassan,MD at 1 site in Egypt.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HOTTIP gene expression (time frame: 2 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 NCT04729855, which also lists 14 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 30 Apr 2025.