Hepatocellular CarcinomaNCT04767750
Role of LncRNA H19 in The Regulation of IGF-1R Expression
An observational study of Hepatocellular Carcinoma and Type 2 Diabetes, run by Mansoura University at 2 sites in Egypt.
Trial summary
Hepatocellular carcinoma (HCC) is a common cancer that poses a heavy economic burden on the healthcare system. In Egypt, it is the most common cause of mortality and morbidity-related cancer. Diabetes mellitus (DM) is a metabolic disorder characterized by hyperglycemia. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma, Type 2 Diabetes, Cancer
- What is being tested?
- Blood sample collection
- How many people
- 101 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2020to 4 Apr 2022
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This case-control study will be conducted in the Department of Medical Biochemistry and Molecular Biology, Faculty of Medicine, Mansoura University. Blood samples will be obtained from 24 HCC patients and 24 HCC \& T2DM patients at the Gastroenterology Center, Mansoura University as well as from 26 T2DM patients at the Specialized Medical Hospital, Mansoura University in the period from December 2020 to December 2021. The study will include 101 patients divided into 4 groups: Group I: 24 HCC patients Group II: 26 T2DM patients Group III: 24 HCC \& T2DM patients Group IV: 27 age and gender-matched healthy control volunteers. Written informed consent will be obtained from all individuals.
Who may be able to join
- Patients aged 40 years or older with a confirmed diagnosis of HCC through triphasic CT and/or dynamic MRI (European Association for the Study of the Liver, 2012).
- Clinically diagnosed T2DM patients aged 40 years or older frequenting Mansoura Specialized Medical Hospital.
- Patients aged 40 years or older with a confirmed diagnosis of HCC through triphasic CT and/or dynamic MRI and who are clinically diagnosed to have T2DM.
Who cannot join
- Patients who underwent previous cancer-directed treatment (radiation and/or chemotherapy).
- Patients with any other systemic disease (Renal disease, other primary tumors).
- T2DM cases (group II):
- Patients with previous or current malignancies.
- Patients with diabetic complications (Diabetic retinopathy, neuropathy, nephropathy).
- Patients with other systemic diseases.
Show all 12Show fewer
- HCC \& T2DM cases (group III):
- Patients who underwent previous cancer-directed treatment (radiation and/or chemotherapy).
- Patients with any other systemic disease.
- Controls (group IV):
- Apparently healthy, age, and gender-matched subjects.
- No history of malignant disease, diabetes, or HCV.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Gastroenterology Center, Mansoura University
Al Mansurah, Dakahliya, 35516
Specialized Medical Hospital, Mansoura University
Al Mansurah, Dakahliya, 35516
About this study
Official title: Role of LncRNA H19 in The Regulation of IGF-1R Expression: A Possible Association Between Type 2 Diabetes and Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is a common cancer that poses a heavy economic burden on the healthcare system. In Egypt, it is the most common cause of mortality and morbidity-related cancer. Diabetes mellitus (DM) is a metabolic disorder characterized by hyperglycemia. Cancer and type II diabetes (T2DM), the world's two most prevalent diseases, share many overlapping risk factors and predisposing pathological conditions. The exact mechanisms linking those two diseases are yet to be fully understood.
In this study, the investigators aim to assess the relationship between Long Non-Coding RNA (lncRNA) H19 and Insulin-Like Growth Factor 1 Receptor (IGF-1R) mRNA gene expressions in the blood samples of HCC \& T2DM patients to investigate the probability of the presence of a pathophysiological link between HCC and DM that may become a therapeutic target for both diseases. To the investigator's knowledge, there is currently no human research study investigating both H19 and IGF-1R in both DM and cancer.
Read the detailed description
Hepatocellular carcinoma (HCC) is a common cancer that poses a heavy economic burden on the healthcare system. It represents the fourth and sixth most common cancer in Egypt and worldwide respectively. Globally, HCC is the fourth most common cause of death from cancer. It was estimated to be responsible for nearly 9.1% of the total deaths in 2012 (746,000 deaths). In Egypt, it is the most common cause of cancer-related mortality, and morbidity (32.35% of the total cancer deaths, mortality data were derived from the World Health Organization (WHO)). The leading risk factor in developing HCC in Egypt is hepatitis C virus (HCV).
Diabetes mellitus (DM) is a metabolic disorder characterized by hyperglycemia, which may be caused by insufficient insulin secretion, insulin resistance, or augmented glucagon production. Cancer and type II diabetes (T2DM), The world's two most prevalent diseases, share many overlapping risk factors and predisposing pathological conditions. Although the T2DM-cancer co-existence has been noted for many decades, the exact mechanisms linking these diseases are yet to be fully understood.
Insulin-Like Growth Factor-1 Receptor (IGF-1R) is a member of the insulin and IGF family. It coordinates a complex downstream signaling network through which it plays essential roles in the regulation of cell growth, proliferation, and survival as well as in glucose homeostasis. IGF-1R plays a crucial role in many tumor-related courses, such as tumor growth and metastasis in addition to drug resistance. The IGF-1R dysregulated signaling pathways in cancer and DM have been reported to be controlled at different levels by non-coding RNAs.
Non-coding RNAs (ncRNAs) are a large category of RNAs that usually do not participate in protein encoding but have a wide range of biological functions through regulation of protein expression and functions. The two most researched classes of ncRNAs are microRNAs (miRNAs) and the long non-coding RNAs (lncRNAs). H19 is a lncRNA that is found to be overexpressed in many solid tumors including HCC. The relationship between H19 and IGF-1R expression levels in addition to the dysregulation of H19 in DM are still inconsistent in literature, warranting further investigations. Ghazal et al. noted that H19 levels are directly proportional to IGF-1R expression levels in women with endometriosis (Ghazal et al., 2015). This is conflicting with Farzi-Molan et al. who remarked the reverse relation between IGF-1R \& H19 during the differentiation of Bone Marrow Mesenchymal Stem Cells (BMSCs) to neural cells
- Conditions
- Hepatocellular Carcinoma, Type 2 Diabetes, Cancer
- Being tested
- Blood sample collection
- Keywords
- LncRNA H19, IGF-1R
- Medical subject headings
- Carcinoma, Hepatocellular, Diabetes Mellitus, Type 2, Neoplasms, Insulin-Like Growth Factor I, Resistance To
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionOther
5ml of peripheral blood samples will be collected into tubes containing EDTA from all subjects and the following procedures will be performed:
- Peripheral blood mononuclear cells (PBMCs) will be isolated from blood samples.
- Total RNA extraction from PBMCs by Trizol reagent and spin column.
- Reverse transcription to cDNA.
- The expression levels of lncRNA H19, IGF-1R mRNA and GAPDH gene (control gene) will be determined by Real-Time Quantitative PCR
| Study group | Role | What they receive |
|---|---|---|
| HCC patients | Measure lncRNA H19 and IGF-1R mRNA gene expression levels in the collected blood samples. Receives: Other: Blood sample collection | |
| T2DM patients | Measure lncRNA H19 and IGF-1R mRNA gene expression levels in the collected blood samples. Receives: Other: Blood sample collection | |
| HCC & T2DM patients | Measure lncRNA H19 and IGF-1R mRNA gene expression levels in the collected blood samples. Receives: Other: Blood sample collection | |
| Controls | Measure lncRNA H19 and IGF-1R mRNA gene expression levels in the collected blood samples. Receives: Other: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the gene expression levels of LncRNA H19 & IGF-1R mRNA, normalized to the housekeeping gene GAPDH expression level, in HCC and T2DM in comparison with healthy controls using Real-Time Quantitative PCR (by the 2^-ΔΔCT method).
To assess if there is a correlation between lncRNA H19 and IGF-1R mRNA gene expressions in the blood samples of HCC \& T2DM patients to investigate the probability of the presence of a pathophysiological link between HCC and DM:
- To measure the IGF-1R mRNA and lncRNA H19 expression levels in HCC \& T2DM patients in comparison with healthy controls.
- To investigate whether lncRNA H19 and IGF-1R mRNA expression levels affect one another.
- To compare IGF-1R and lncRNA H19 expression levels in HCC associated with T2DM patients in contrast with sole affection with HCC or T2DM.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Jan 2020
- Primary completion30 Jan 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noura MS Shehabeldin, M.B.B.Ch, Principal investigator, Faculty of Medicine, Mansoura University.Mohamed AA Zahran, M.D., Study director, Faculty of Medicine, Mansoura University.Heba K Mohamed, M.D., Study chair, Faculty of Medicine, Mansoura University.Nora M Hussein, M.D., Study chair, Faculty of Medicine, Mansoura University.Ahmed Shehta, M.D., Study chair, Gastroenterology Center, Mansoura UniversityHelmy Ezzat, M.D., Study chair, Gastroenterology Center, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767750
- Sponsor's protocol ID
- MS.20.10.26
- Status last verified
- Feb 2021
- First submitted
- 21 Dec 2020
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen B, Li J, Chi D, Sahnoune I, Calin S, Girnita L, Calin GA. Non-Coding RNAs in IGF-1R Signaling Regulation: The Underlying Pathophysiological Link between Diabetes and Cancer. Cells. 2019 Dec 14;8(12):1638. doi: 10.3390/cells8121638.
PubMed 31847392Chitnis MM, Yuen JS, Protheroe AS, Pollak M, Macaulay VM. The type 1 insulin-like growth factor receptor pathway. Clin Cancer Res. 2008 Oct 15;14(20):6364-70. doi: 10.1158/1078-0432.CCR-07-4879.
PubMed 18927274Ding J, Li C, Tang J, Yi C, Liu JY, Qiu M. Higher Expression of Proteins in IGF/IR Axes in Colorectal Cancer is Associated with Type 2 Diabetes Mellitus. Pathol Oncol Res. 2016 Oct;22(4):773-9. doi: 10.1007/s12253-016-0065-6. Epub 2016 May 2.
PubMed 27138191Fabbri M, Girnita L, Varani G, Calin GA. Decrypting noncoding RNA interactions, structures, and functional networks. Genome Res. 2019 Sep;29(9):1377-1388. doi: 10.1101/gr.247239.118. Epub 2019 Aug 21.
PubMed 31434680Farzi-Molan A, Babashah S, Bakhshinejad B, Atashi A, Fakhr Taha M. Down-regulation of the non-coding RNA H19 and its derived miR-675 is concomitant with up-regulation of insulin-like growth factor receptor type 1 during neural-like differentiation of human bone marrow mesenchymal stem cells. Cell Biol Int. 2018 Aug;42(8):940-948. doi: 10.1002/cbin.10960. Epub 2018 Mar 30.
PubMed 29512257Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
PubMed 25220842Forner A, Reig M, Bruix J. Hepatocellular carcinoma. Lancet. 2018 Mar 31;391(10127):1301-1314. doi: 10.1016/S0140-6736(18)30010-2. Epub 2018 Jan 5.
PubMed 29307467Ghazal S, McKinnon B, Zhou J, Mueller M, Men Y, Yang L, Mueller M, Flannery C, Huang Y, Taylor HS. H19 lncRNA alters stromal cell growth via IGF signaling in the endometrium of women with endometriosis. EMBO Mol Med. 2015 Aug;7(8):996-1003. doi: 10.15252/emmm.201505245.
PubMed 26089099Global Burden of Disease Liver Cancer Collaboration; Akinyemiju T, Abera S, Ahmed M, Alam N, Alemayohu MA, Allen C, Al-Raddadi R, Alvis-Guzman N, Amoako Y, Artaman A, Ayele TA, Barac A, Bensenor I, Berhane A, Bhutta Z, Castillo-Rivas J, Chitheer A, Choi JY, Cowie B, Dandona L, Dandona R, Dey S, Dicker D, Phuc H, Ekwueme DU, Zaki MS, Fischer F, Furst T, Hancock J, Hay SI, Hotez P, Jee SH, Kasaeian A, Khader Y, Khang YH, Kumar A, Kutz M, Larson H, Lopez A, Lunevicius R, Malekzadeh R, McAlinden C, Meier T, Mendoza W, Mokdad A, Moradi-Lakeh M, Nagel G, Nguyen Q, Nguyen G, Ogbo F, Patton G, Pereira DM, Pourmalek F, Qorbani M, Radfar A, Roshandel G, Salomon JA, Sanabria J, Sartorius B, Satpathy M, Sawhney M, Sepanlou S, Shackelford K, Shore H, Sun J, Mengistu DT, Topor-Madry R, Tran B, Ukwaja KN, Vlassov V, Vollset SE, Vos T, Wakayo T, Weiderpass E, Werdecker A, Yonemoto N, Younis M, Yu C, Zaidi Z, Zhu L, Murray CJL, Naghavi M, Fitzmaurice C. The Burden of Primary Liver Cancer and Underlying Etiologies From 1990 to 2015 at the Global, Regional, and National Level: Results From the Global Burden of Disease Study 2015. JAMA Oncol. 2017 Dec 1;3(12):1683-1691. doi: 10.1001/jamaoncol.2017.3055.
PubMed 28983565Hashad D, Elbanna A, Ibrahim A, Khedr G. Evaluation of the Role of Circulating Long Non-Coding RNA H19 as a Promising Novel Biomarker in Plasma of Patients with Gastric Cancer. J Clin Lab Anal. 2016 Nov;30(6):1100-1105. doi: 10.1002/jcla.21987. Epub 2016 May 17.
PubMed 27184562Huang JY, Wang SY, Lin Y, Yi HC, Niu JJ. The Diagnostic Performance of lncRNAs from Blood Specimens in Patients with Hepatocellular Carcinoma: A Meta-Analysis. Lab Med. 2021 Jan 4;52(1):64-73. doi: 10.1093/labmed/lmaa050.
PubMed 32700735Ibrahim 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 25328522European Association For The Study Of The Liver; European Organisation For Research And Treatment Of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2012 Apr;56(4):908-43. doi: 10.1016/j.jhep.2011.12.001. No abstract available.
PubMed 22424438Matouk IJ, DeGroot N, Mezan S, Ayesh S, Abu-lail R, Hochberg A, Galun E. The H19 non-coding RNA is essential for human tumor growth. PLoS One. 2007 Sep 5;2(9):e845. doi: 10.1371/journal.pone.0000845.
PubMed 17786216Pollak M. The insulin and insulin-like growth factor receptor family in neoplasia: an update. Nat Rev Cancer. 2012 Feb 16;12(3):159-69. doi: 10.1038/nrc3215.
PubMed 22337149
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of LncRNA H19 in The Regulation of IGF-1R Expression: A Possible Association Between Type 2 Diabetes and Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04767750
- Acronym / sponsor ID
- MS.20.10.26
- Conditions
- Hepatocellular Carcinoma, Type 2 Diabetes, Cancer
- Keywords
- LncRNA H19, IGF-1R
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 23 Feb 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.
Hepatocellular carcinoma (HCC) is a common cancer that poses a heavy economic burden on the healthcare system. In Egypt, it is the most common cause of mortality and morbidity-related cancer. Diabetes mellitus (DM) is a metabolic disorder characterized by hyperglycemia. Cancer and type II diabetes (T2DM), the world's two most prevalent diseases, share many overlapping risk factors and predisposing pathological conditions. The exact mechanisms linking those two diseases are yet to be fully understood.
In this study, the investigators aim to assess the relationship between Long Non-Coding RNA (lncRNA) H19 and Insulin-Like Growth Factor 1 Receptor (IGF-1R) mRNA gene expressions in the blood samples of HCC \& T2DM patients to investigate the probability of the presence of a pathophysiological link between HCC and DM that may become a therapeutic target for both diseases. To the investigator's knowledge, there is currently no human research study investigating both H19 and IGF-1R in both DM and cancer.
Detailed description
Hepatocellular carcinoma (HCC) is a common cancer that poses a heavy economic burden on the healthcare system. It represents the fourth and sixth most common cancer in Egypt and worldwide respectively. Globally, HCC is the fourth most common cause of death from cancer. It was estimated to be responsible for nearly 9.1% of the total deaths in 2012 (746,000 deaths). In Egypt, it is the most common cause of cancer-related mortality, and morbidity (32.35% of the total cancer deaths, mortality data were derived from the World Health Organization (WHO)). The leading risk factor in developing HCC in Egypt is hepatitis C virus (HCV).
Diabetes mellitus (DM) is a metabolic disorder characterized by hyperglycemia, which may be caused by insufficient insulin secretion, insulin resistance, or augmented glucagon production. Cancer and type II diabetes (T2DM), The world's two most prevalent diseases, share many overlapping risk factors and predisposing pathological conditions. Although the T2DM-cancer co-existence has been noted for many decades, the exact mechanisms linking these diseases are yet to be fully understood.
Insulin-Like Growth Factor-1 Receptor (IGF-1R) is a member of the insulin and IGF family. It coordinates a complex downstream signaling network through which it plays essential roles in the regulation of cell growth, proliferation, and survival as well as in glucose homeostasis. IGF-1R plays a crucial role in many tumor-related courses, such as tumor growth and metastasis in addition to drug resistance. The IGF-1R dysregulated signaling pathways in cancer and DM have been reported to be controlled at different levels by non-coding RNAs.
Non-coding RNAs (ncRNAs) are a large category of RNAs that usually do not participate in protein encoding but have a wide range of biological functions through regulation of protein expression and functions. The two most researched classes of ncRNAs are microRNAs (miRNAs) and the long non-coding RNAs (lncRNAs). H19 is a lncRNA that is found to be overexpressed in many solid tumors including HCC. The relationship between H19 and IGF-1R expression levels in addition to the dysregulation of H19 in DM are still inconsistent in literature, warranting further investigations. Ghazal et al. noted that H19 levels are directly proportional to IGF-1R expression levels in women with endometriosis (Ghazal et al., 2015). This is conflicting with Farzi-Molan et al. who remarked the reverse relation between IGF-1R \& H19 during the differentiation of Bone Marrow Mesenchymal Stem Cells (BMSCs) to neural cells
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HCC patients | – | Other: Blood sample collectionMeasure lncRNA H19 and IGF-1R mRNA gene expression levels in the collected blood samples. |
| T2DM patients | – | Other: Blood sample collectionMeasure lncRNA H19 and IGF-1R mRNA gene expression levels in the collected blood samples. |
| HCC & T2DM patients | – | Other: Blood sample collectionMeasure lncRNA H19 and IGF-1R mRNA gene expression levels in the collected blood samples. |
| Controls | – | Other: Blood sample collectionMeasure lncRNA H19 and IGF-1R mRNA gene expression levels in the collected blood samples. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This case-control study will be conducted in the Department of Medical Biochemistry and Molecular Biology, Faculty of Medicine, Mansoura University. Blood samples will be obtained from 24 HCC patients and 24 HCC \& T2DM patients at the Gastroenterology Center, Mansoura University as well as from 26 T2DM patients at the Specialized Medical Hospital, Mansoura University in the period from December 2020 to December 2021. The study will include 101 patients divided into 4 groups: Group I: 24 HCC patients Group II: 26 T2DM patients Group III: 24 HCC \& T2DM patients Group IV: 27 age and gender-matched healthy control volunteers. Written informed consent will be obtained from all individuals.
Key inclusion criteria (3 listed)
- Patients aged 40 years or older with a confirmed diagnosis of HCC through triphasic CT and/or dynamic MRI (European Association for the Study of the Liver, 2012).
- Clinically diagnosed T2DM patients aged 40 years or older frequenting Mansoura Specialized Medical Hospital.
- Patients aged 40 years or older with a confirmed diagnosis of HCC through triphasic CT and/or dynamic MRI and who are clinically diagnosed to have T2DM.
Key exclusion criteria (12 listed)
- Patients who underwent previous cancer-directed treatment (radiation and/or chemotherapy).
- Patients with any other systemic disease (Renal disease, other primary tumors).
- Patients with previous or current malignancies.
- Patients with diabetic complications (Diabetic retinopathy, neuropathy, nephropathy).
- Patients with other systemic 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 |
|---|---|---|
| Blood sample collection5ml of peripheral blood samples will be collected into tubes containing EDTA from all subjects and the following procedures will be performed: * Peripheral blood mononuclear cells (PBMCs) will be isolated from blood samples. * Total RNA extraction from PBMCs by Trizol reagent and spin column. * Reverse transcription to cDNA. * The expression levels of lncRNA H19, IGF-1R mRNA and GAPDH gene (control gene) will be determined by Real-Time Quantitative PCR | Other | Controls, HCC & T2DM patients, HCC patients, T2DM patients |
Primary outcome
Measurement of the gene expression levels of LncRNA H19 & IGF-1R mRNA, normalized to the housekeeping gene GAPDH expression level, in HCC and T2DM in comparison with healthy controls using Real-Time Quantitative PCR (by the 2^-ΔΔCT method).
Time frame: baseline
To assess if there is a correlation between lncRNA H19 and IGF-1R mRNA gene expressions in the blood samples of HCC \& T2DM patients to investigate the probability of the presence of a pathophysiological link between HCC and DM: * To measure the IGF-1R mRNA and lncRNA H19 expression levels in HCC \& T2DM patients in comparison with healthy controls. * To investigate whether lncRNA H19 and IGF-1R mRNA expression levels affect one another. * To compare IGF-1R and lncRNA H19 expression levels in HCC associated with T2DM patients in contrast with sole affection with HCC or T2DM.
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 7 Apr 2022.
- Background: PubMed 31847392Chen B, Li J, Chi D, Sahnoune I, Calin S, Girnita L, Calin GA. Non-Coding RNAs in IGF-1R Signaling Regulation: The Underlying Pathophysiological Link between Diabetes and Cancer. Cells. 2019 Dec 14;8(12):1638. doi: 10.3390/cells8121638.
- Background: PubMed 18927274Chitnis MM, Yuen JS, Protheroe AS, Pollak M, Macaulay VM. The type 1 insulin-like growth factor receptor pathway. Clin Cancer Res. 2008 Oct 15;14(20):6364-70. doi: 10.1158/1078-0432.CCR-07-4879.
- Background: PubMed 27138191Ding J, Li C, Tang J, Yi C, Liu JY, Qiu M. Higher Expression of Proteins in IGF/IR Axes in Colorectal Cancer is Associated with Type 2 Diabetes Mellitus. Pathol Oncol Res. 2016 Oct;22(4):773-9. doi: 10.1007/s12253-016-0065-6. Epub 2016 May 2.
- Background: PubMed 31434680Fabbri M, Girnita L, Varani G, Calin GA. Decrypting noncoding RNA interactions, structures, and functional networks. Genome Res. 2019 Sep;29(9):1377-1388. doi: 10.1101/gr.247239.118. Epub 2019 Aug 21.
- Background: PubMed 29512257Farzi-Molan A, Babashah S, Bakhshinejad B, Atashi A, Fakhr Taha M. Down-regulation of the non-coding RNA H19 and its derived miR-675 is concomitant with up-regulation of insulin-like growth factor receptor type 1 during neural-like differentiation of human bone marrow mesenchymal stem cells. Cell Biol Int. 2018 Aug;42(8):940-948. doi: 10.1002/cbin.10960. Epub 2018 Mar 30.
- Background: PubMed 25220842Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
- Background: PubMed 29307467Forner A, Reig M, Bruix J. Hepatocellular carcinoma. Lancet. 2018 Mar 31;391(10127):1301-1314. doi: 10.1016/S0140-6736(18)30010-2. Epub 2018 Jan 5.
- Background: PubMed 26089099Ghazal S, McKinnon B, Zhou J, Mueller M, Men Y, Yang L, Mueller M, Flannery C, Huang Y, Taylor HS. H19 lncRNA alters stromal cell growth via IGF signaling in the endometrium of women with endometriosis. EMBO Mol Med. 2015 Aug;7(8):996-1003. doi: 10.15252/emmm.201505245.
- Background: PubMed 28983565Global Burden of Disease Liver Cancer Collaboration; Akinyemiju T, Abera S, Ahmed M, Alam N, Alemayohu MA, Allen C, Al-Raddadi R, Alvis-Guzman N, Amoako Y, Artaman A, Ayele TA, Barac A, Bensenor I, Berhane A, Bhutta Z, Castillo-Rivas J, Chitheer A, Choi JY, Cowie B, Dandona L, Dandona R, Dey S, Dicker D, Phuc H, Ekwueme DU, Zaki MS, Fischer F, Furst T, Hancock J, Hay SI, Hotez P, Jee SH, Kasaeian A, Khader Y, Khang YH, Kumar A, Kutz M, Larson H, Lopez A, Lunevicius R, Malekzadeh R, McAlinden C, Meier T, Mendoza W, Mokdad A, Moradi-Lakeh M, Nagel G, Nguyen Q, Nguyen G, Ogbo F, Patton G, Pereira DM, Pourmalek F, Qorbani M, Radfar A, Roshandel G, Salomon JA, Sanabria J, Sartorius B, Satpathy M, Sawhney M, Sepanlou S, Shackelford K, Shore H, Sun J, Mengistu DT, Topor-Madry R, Tran B, Ukwaja KN, Vlassov V, Vollset SE, Vos T, Wakayo T, Weiderpass E, Werdecker A, Yonemoto N, Younis M, Yu C, Zaidi Z, Zhu L, Murray CJL, Naghavi M, Fitzmaurice C. The Burden of Primary Liver Cancer and Underlying Etiologies From 1990 to 2015 at the Global, Regional, and National Level: Results From the Global Burden of Disease Study 2015. JAMA Oncol. 2017 Dec 1;3(12):1683-1691. doi: 10.1001/jamaoncol.2017.3055.
- Background: PubMed 27184562Hashad D, Elbanna A, Ibrahim A, Khedr G. Evaluation of the Role of Circulating Long Non-Coding RNA H19 as a Promising Novel Biomarker in Plasma of Patients with Gastric Cancer. J Clin Lab Anal. 2016 Nov;30(6):1100-1105. doi: 10.1002/jcla.21987. Epub 2016 May 17.
- Background: PubMed 32700735Huang JY, Wang SY, Lin Y, Yi HC, Niu JJ. The Diagnostic Performance of lncRNAs from Blood Specimens in Patients with Hepatocellular Carcinoma: A Meta-Analysis. Lab Med. 2021 Jan 4;52(1):64-73. doi: 10.1093/labmed/lmaa050.
- Background: PubMed 25328522Ibrahim 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.
- Abudeif, A. (2019) 'Epidemiology and Risk Factors of Hepatocellular Carcinoma in Egypt', Sohag Medical Journal. Sohag University; Faculty of Medicine, 23(3), pp. 8-12.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
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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.
Noura MS Shehabeldin, M.B.B.Ch principal investigator
Faculty of Medicine, Mansoura University.
Mohamed AA Zahran, M.D. study director
Faculty of Medicine, Mansoura University.
Heba K Mohamed, M.D. study chair
Faculty of Medicine, Mansoura University.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Type 2 Diabetes, run by Mansoura University at 2 sites 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 12 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 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Measurement of the gene expression levels of LncRNA H19 & IGF-1R mRNA, normalized to the housekeeping gene GAPDH expression level, in HCC and T2DM in comparison with healthy controls using Real-Time Quantitative PCR (by the 2^-ΔΔCT method). (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 NCT04767750, which also lists 21 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 7 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.