Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
100 participants
OBSERVATIONAL
2018-01-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Identification of Prognostic Gene Mutations in Biliary Tract Cancer Using Whole Genome Sequencing
NCT03718897
Genomics and Prognosis in GI Cancers
NCT05767697
Circulating Free DNA Analysis in Gastrointestinal Cancer, Genitourinary Cancer, Rare Cancer
NCT02067754
Early Detection of Gastric Cancer Using Plasma Cell-free DNA Fragmentomics
NCT05269056
The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer
NCT05036486
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Of the multiple molecular alterations observed in GBC, it has not yet been possible to pinpoint which ones are the "driver" genes or controllers of the neoplastic process and to differentiate them from the "passenger" genes, those observed mainly in sporadic malignant tumors like GBC in which epigenetic alterations predominate. The most frequently mutated genes in GBC are: TP53 (41%), CDKN2A (28%) KRAS (19%), TERT (8%), CTNNB1 (8%) and PI3K (7%). The signalling pathway of the ERBB family is one of the most frequently mutated in GBC. These receptors participate in regulating cell proliferation, differentiation and survival. Their amplification mainly translates into protein over expression. The receptor HER2/NEU, after dimerization activates a large variety of downstream pathways such as RAS-RAF-MEK-ERK1/2 or PI3k-AKT-MTOR with great influence on cell proliferation. On the other hand, PTEN (phosphatase and tensin homolog) is a tumor suppressor gene that encodes a protein with phosphatase function that inactivates substrates like PI3K The absence of the PTEN functional protein permits the activation of PI3k with an even greater intensity than the activating mutation of PI3K itself. The uncontrolled production of PIP3 is one of the most important effectors of the PI3K/AKT pathway with mTOR stimulating protein synthesis that regulate apoptosis. The immunohistochemical expression of the PTEN protein is considered a good way to evaluate the functional state of the gene.
1. Comprehensive history and physical examination of the patients and all the details will be recorded in the preset proforma. All routine investigations as indicated including a biopsy to establish a diagnosis and CT/MRI/MRCP of the abdomen to measure the tumor dimensions and stage the disease before initiation of treatment will be recorded.
2. The archival tissue will be studied for expression of gene mutation by molecular analysis using Next Generation Sequencing. Patients treated between 2017-2020 where NGS information is available will also be included in retrospect. Their data will be extracted from the Medical records, and attempts will be made to contact them for follow-up.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Gallbladder Cancer
Patients with confirmed diagnosis of gallbladder cancer
Next generation sequencing
NGS is carried out on DNA isolated from paraffin embedded tissue
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Next generation sequencing
NGS is carried out on DNA isolated from paraffin embedded tissue
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Pregnant and lactating women
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Banaras Hindu University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Manoj Pandey
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Manoj Pandey, Ms, PhD
Role: PRINCIPAL_INVESTIGATOR
Banaras Hindu University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Banaras Hindu University
Varanasi, Uttar Pradesh, India
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Sanders G, Kingsnorth AN. Gallstones. BMJ. 2007 Aug 11;335(7614):295-9. doi: 10.1136/bmj.39267.452257.AD. No abstract available.
Hsing AW, Gao YT, Han TQ, Rashid A, Sakoda LC, Wang BS, Shen MC, Zhang BH, Niwa S, Chen J, Fraumeni JF Jr. Gallstones and the risk of biliary tract cancer: a population-based study in China. Br J Cancer. 2007 Dec 3;97(11):1577-82. doi: 10.1038/sj.bjc.6604047. Epub 2007 Nov 13.
Ishiguro S, Inoue M, Kurahashi N, Iwasaki M, Sasazuki S, Tsugane S. Risk factors of biliary tract cancer in a large-scale population-based cohort study in Japan (JPHC study); with special focus on cholelithiasis, body mass index, and their effect modification. Cancer Causes Control. 2008 Feb;19(1):33-41. doi: 10.1007/s10552-007-9067-8. Epub 2007 Sep 30.
Trajber HJ, Szego T, de Camargo HS Jr, Mester M, Marujo WC, Roll S. Adenocarcinoma of the gallbladder in two siblings. Cancer. 1982 Sep 15;50(6):1200-3. doi: 10.1002/1097-0142(19820915)50:63.0.co;2-a.
Weiss KM, Ferrell RE, Hanis CL, Styne PN. Genetics and epidemiology of gallbladder disease in New World native peoples. Am J Hum Genet. 1984 Nov;36(6):1259-78.
Begnami MD, Fukuda E, Fregnani JH, Nonogaki S, Montagnini AL, da Costa WL Jr, Soares FA. Prognostic implications of altered human epidermal growth factor receptors (HERs) in gastric carcinomas: HER2 and HER3 are predictors of poor outcome. J Clin Oncol. 2011 Aug 1;29(22):3030-6. doi: 10.1200/JCO.2010.33.6313. Epub 2011 Jun 27.
Tafe LJ, Tsongalis GJ. The human epidermal growth factor receptor 2 (HER2). Clin Chem Lab Med. 2011 Sep 15;50(1):23-30. doi: 10.1515/CCLM.2011.707.
Ocana A, Vera-Badillo F, Al-Mubarak M, Templeton AJ, Corrales-Sanchez V, Diez-Gonzalez L, Cuenca-Lopez MD, Seruga B, Pandiella A, Amir E. Activation of the PI3K/mTOR/AKT pathway and survival in solid tumors: systematic review and meta-analysis. PLoS One. 2014 Apr 28;9(4):e95219. doi: 10.1371/journal.pone.0095219. eCollection 2014.
Lavorato-Rocha AM, Anjos LG, Cunha IW, Vassallo J, Soares FA, Rocha RM. Immunohistochemical assessment of PTEN in vulvar cancer: best practices for tissue staining, evaluation, and clinical association. Methods. 2015 May;77-78:20-4. doi: 10.1016/j.ymeth.2014.12.017. Epub 2015 Jan 3.
Sakr RA, Barbashina V, Morrogh M, Chandarlapaty S, Andrade VP, Arroyo CD, Olvera N, King TA. Protocol for PTEN expression by immunohistochemistry in formalin-fixed paraffin-embedded human breast carcinoma. Appl Immunohistochem Mol Morphol. 2010 Jul;18(4):371-4. doi: 10.1097/PAI.0b013e3181d50bd5.
Djordjevic B, Hennessy BT, Li J, Barkoh BA, Luthra R, Mills GB, Broaddus RR. Clinical assessment of PTEN loss in endometrial carcinoma: immunohistochemistry outperforms gene sequencing. Mod Pathol. 2012 May;25(5):699-708. doi: 10.1038/modpathol.2011.208. Epub 2012 Feb 3.
Rajput M, Chigurupati S, Purwar R, Shukla M, Pandey M. MAP kinase and mammalian target of rapamycin are main pathways of gallbladder carcinogenesis: results from bioinformatic analysis of next generation sequencing data from a hospital-based cohort (NCT05404347). Mol Biol Rep. 2022 Nov;49(11):10153-10163. doi: 10.1007/s11033-022-07874-4. Epub 2022 Aug 26.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NGSGB1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.