Clinical trial · Observational
Implication of Long Non-coding RNA HOTTIP Haplotype on Liver Cancer Metastasis
Implication of Long Non-coding RNA HOTTIP Haplotype
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hepatocellular carcinoma (HCC) represents the fourth common cancer and the most common cause of mortality-caused and morbidity-related cancer. Different reports implied several lncRNAs role in the progression and metastasis of HCC such as Homeobox A (HOXA) transcript at the distal tip (HOTTIP). Dysregulation of HOTTIP is associated with various malignancies including HCC, affecting survival and prognosis of cancer patients. HOTTIP promoted HCC cell proliferation/metastasis and might act as an oncogenic-lncRNA in HCC. Genetic variations such as single-nucleotide polymorphisms (SNPs), when inherited together, as a group, known as haplotypes. Haplotypes can alter the expression of coding genes and the protein non-coding genes like lncRNAs, therefore, affecting the disease course, including liver, a hypothesis to be addressed. Only few studies have focused on the polymorphisms of the onco-lncRNA HOTTIP gene. A study found that specific HOTTIP SNPs have the potential to be biomarkers for HCC risk and prognosis, where one haplotype of HOTTIP "rs17501292-rs2067087-rs17427960" showed a 1.91-fold increased risk of HCC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Non-metastatic HCC group
- description
- 129 HCC patients attending the Faculty of Medicine, Ain Shams University Hospital, males and females (according to availability), diagnosed with primary HCC receiving any type of therapy (neoadjuvant or radiotherapy). Criteria for HCC diagnosis following the ASU hospital role relying on AFP level and CT scan or the fine needle biopsy. Groups to be matched socioeconomically, in age range, residence.
- label
- Metastatic HCC group
- description
- 69 HCC patients attending the Faculty of Medicine, Ain Shams University Hospital, males and females (according to availability), diagnosed with primary HCC receiving any type of therapy (neoadjuvant or radiotherapy). Criteria for HCC diagnosis following the ASU hospital role relying on AFP level and CT scan or the fine needle biopsy. Groups to be matched socioeconomically, in age range, residence.
Primary outcomes (1)
- measure
- Primary outcome
- timeFrame
- 29 months
- description
- By the end of the current study, investigators will have elucidated the association of polymorphisms of SNPs (rs17501292\& rs2067087) in the lncRNA HOTTIP with HCC metastasis risk by comparing the two group of patients together using logistic regression. Additionally, investigators will assess prognosis in metastatic and non-metastatic primary HCC patients in liquid biopsy samples by using APRI score as an indicator of the prognosis. Finally, by using Kaplan-Meier curve, the overall survival of each group will be compared and related with each SNP polymorph.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * HCC patients attending the Faculty of Medicine, Ain Shams University Hospital, with 1:1 or 1:2 ratio for the HCC groups metastatic vs non metastatic HCC groups (according to clinical evidence/relevance and/or availability). Group 1; non-metastatic HCC patients, Group 2; metastatic HCC patients, diagnosed with primary HCC receiving any type of therapy (neoadjuvant or radiotherapy). Eligibility criterion are adult age and male/female 1:1 according to availability. Criteria for HCC diagnosis following the ASU hospital role relying on AFP level and CT scan or the fine needle biopsy. Groups to be matched socioeconomically, in age range, residence (case-controlled study). Exclusion Criteria: * HCC patients who have history of liver transplantation, have other cancer types at the time of selection, presented by renal insufficiency, and thyroid dysfunction will be excluded from the study. Additionally, patients with incomplete data or histopathology diagnosis.
References
Publications (12)
- BACKGROUNDRashed WM, Kandeil MAM, Mahmoud MO, Ezzat S. Hepatocellular Carcinoma (HCC) in Egypt: A comprehensive overview. J Egypt Natl Canc Inst. 2020 Jan 16;32(1):5. doi: 10.1186/s43046-020-0016-x. PMID 32372179
- BACKGROUNDTomimaru Y, Eguchi H, Nagano H, Wada H, Kobayashi S, Marubashi S, Tanemura M, Tomokuni A, Takemasa I, Umeshita K, Kanto T, Doki Y, Mori M. Circulating microRNA-21 as a novel biomarker for hepatocellular carcinoma. J Hepatol. 2012 Jan;56(1):167-75. doi: 10.1016/j.jhep.2011.04.026. Epub 2011 Jul 13. PMID 21749846
- BACKGROUNDGeorge J, Patel T. Noncoding RNA as therapeutic targets for hepatocellular carcinoma. Semin Liver Dis. 2015 Feb;35(1):63-74. doi: 10.1055/s-0034-1397350. Epub 2015 Jan 29. PMID 25632936
- BACKGROUNDTsang FH, Au SL, Wei L, Fan DN, Lee JM, Wong CC, Ng IO, Wong CM. Long non-coding RNA HOTTIP is frequently up-regulated in hepatocellular carcinoma and is targeted by tumour suppressive miR-125b. Liver Int. 2015 May;35(5):1597-606. doi: 10.1111/liv.12746. Epub 2015 Jan 27. PMID 25424744
- BACKGROUNDLian Y, Cai Z, Gong H, Xue S, Wu D, Wang K. HOTTIP: a critical oncogenic long non-coding RNA in human cancers. Mol Biosyst. 2016 Oct 18;12(11):3247-3253. doi: 10.1039/c6mb00475j. PMID 27546609
- BACKGROUNDDong SS, He WM, Ji JJ, Zhang C, Guo Y, Yang TL. LDBlockShow: a fast and convenient tool for visualizing linkage disequilibrium and haplotype blocks based on variant call format files. Brief Bioinform. 2021 Jul 20;22(4):bbaa227. doi: 10.1093/bib/bbaa227. PMID 33126247
- BACKGROUNDHu Z, Chen J, Tian T, Zhou X, Gu H, Xu L, Zeng Y, Miao R, Jin G, Ma H, Chen Y, Shen H. Genetic variants of miRNA sequences and non-small cell lung cancer survival. J Clin Invest. 2008 Jul;118(7):2600-8. doi: 10.1172/JCI34934.