NCT05404347

Brief Summary

Evidence suggests distinct models of molecular and pathologic progression, and a growing body of genetics data points to a heterogeneous collection of underlying mutations in key oncogenes and tumor suppressor genes. Although tumor genetics have been used to tailor individual treatment regimens and guide clinical decision making in other cancers, these principles have not been applied in gallbladder malignancy. Recent clinical trials with targeted therapies seem promising, although the relationships between subsets of patients with positive responses to therapy and tumor genetics remain unexplored.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress93%
Jan 2018Dec 2026

Study Start

First participant enrolled

January 1, 2018

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

9 years

First QC Date

May 31, 2022

Last Update Submit

August 9, 2024

Conditions

Gallbladder Cancer

Outcome Measures

Primary Outcomes (2)

  • Response to treatment

    Response to treatment in terms of chemotherapy

    1 year

  • Overall Survival

    Survival of patients from the date of diagnosis to closure of study or death which ever is earlier

    5 year

Secondary Outcomes (2)

  • PFS

    5 yers

  • RFS

    5 year

Study Arms (1)

Gallbladder Cancer

Patients with confirmed diagnosis of gallbladder cancer

Diagnostic Test: Next generation sequencing

Interventions

Next generation sequencingDIAGNOSTIC_TEST

NGS is carried out on DNA isolated from paraffin embedded tissue

Gallbladder Cancer

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with histologically confirmed diagnosis of gallbladder cancer irrespective of stage, being treated with palliative or curative intent with standard of care for that stage of carcinoma of the gallbladder

You may qualify if:

  • Treatment naïve patients with histologically proven carcinoma of the gallbladder.

You may not qualify if:

  • No histological evidence of malignancy
  • Pregnant and lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banaras Hindu University

Varanasi, Uttar Pradesh, 221005, India

RECRUITING

Related Publications (12)

  • Sanders G, Kingsnorth AN. Gallstones. BMJ. 2007 Aug 11;335(7614):295-9. doi: 10.1136/bmj.39267.452257.AD. No abstract available.

    PMID: 17690370BACKGROUND

  • 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.

    PMID: 18000509BACKGROUND

  • 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.

    PMID: 17906958BACKGROUND

  • 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.

    PMID: 7104965BACKGROUND

  • 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.

    PMID: 6517051BACKGROUND

  • 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.

    PMID: 21709195BACKGROUND

  • 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.

    PMID: 21919545BACKGROUND

  • 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.

    PMID: 24777052BACKGROUND

  • 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.

    PMID: 25562748BACKGROUND

  • 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.

    PMID: 20216404BACKGROUND

  • 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.

    PMID: 22301702BACKGROUND

  • 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.

    PMID: 36018415RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Paraffin embedded tissue

MeSH Terms

Conditions

Gallbladder Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Study Officials

  • Manoj Pandey, Ms, PhD

    Banaras Hindu University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manoj Pandey, MS, PhD

CONTACT

2361014mpandey66@bhu.ac.in

S K Singh, MD, DM

CONTACT

2361014mdean.ims@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 3, 2022

Study Start

January 1, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

Anonymized data will be made available on reasonable request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
3 months
Access Criteria
Request

Locations

IN(1)