NCT03254888

Brief Summary

• Bladder cancer is the most common malignancy of the urinary tract. It represents the 7th most commonly diagnosed cancer in male population worldwide and drops to the 11th when both genders are considered . According to the American cancer society's estimates of bladder cancer in 2017, the number of the new cases of bladder cancer is 79,030, and the mortality figures reached 16,870 .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
3.3 years until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

August 17, 2017

Last Update Submit

July 7, 2020

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • autophagy marker

    differences in the level of Atg7(autophagy marker) in Low Grade bladder cancer and High Grade bladder cancer groups in comparison with safety margin and healthy control group.

    baseline

Secondary Outcomes (1)

  • stress markers

    baseline

Study Arms (4)

Low Grade group

• 50 tumor tissue samples from patients with Low Grade Bladder Cancer undergoing either trans urethral resection of bladder tumor or Radical Cystectomy , The followings markers must be estimated : 1. Autophagy markers: * ( Atg7) level using (quantitative real time polymerase chain reaction). * (LC3A)level using immunohistochemistry . 2. ER-stress marker: (ATF6) level using ELISA(Enzyme Linked Immuno sorbent Assay) 3. Oxidative stress Marker:(MDA)using chemical method 4. Apoptotic marker:(caspase 3) using(quantitative real time polymerase chain reaction) .

High Grade group

• 50 tumor tissue samples from patients with High Grade Bladder Cancer undergoing either trans urethral resection of bladder tumor or Radical Cystectomy, The followings markers must be estimated : 1. Autophagy markers: * ( Atg7) level using (quantitative real time polymerase chain reaction). * (LC3A)level using immunohistochemistry . 2. ER-stress marker: (ATF6) level using ELISA(Enzyme Linked Immuno sorbent Assay) 3. Oxidative stress Marker:(MDA)using chemical method 4. Apoptotic marker:(caspase 3) using (quantitative real time polymerase chain reaction) .

Safety margin group

• 50 normal bladder urothelial tissue samples from the safety margin around the tumor(0.5cm to the tumor), The followings markers must be estimated : 1. Autophagy markers: * ( Atg7) level using (quantitative real time polymerase chain reaction). * (LC3A)level using immunohistochemistry . 2. ER-stress marker: (ATF6) level using ELISA(Enzyme Linked Immuno sorbent Assay) 3. Oxidative stress Marker:(MDA)using chemical method 4. Apoptotic marker:(caspase 3) using (quantitative real time polymerase chain reaction).

Control group

• 50 (age and sex matched )control The followings markers must be estimated : 1. Autophagy markers: * ( Atg7) level using (quantitative real time polymerase chain reaction). * (LC3A)level using immunohistochemistry . 2. ER-stress marker: (ATF6) level using ELISA(Enzyme Linked Immuno sorbent Assay) 3. Oxidative stress Marker:(MDA)using chemical method 4. Apoptotic marker:(caspase 3) using (quantitative real time polymerase chain reaction)..

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with confirmed bladder cancer (histopathologically) having LGBC(Low Grade bladder cancer) undergoing either TUR(transurethral resection of Bladder Tumour) or Radical Cystectomy and patients having HGBC(High Grade bladder cancer) undergoing either TUR(transurethral resection of Bladder Tumour) or Radical cystectomy. Healthy controls\[age and gender matched\](with no previous history of gross hematuria, urolithiasis, or active urinary tract infection)

You may qualify if:

  • )patients confirmed histopathologically to have bladder cancer. 2) Both sexes. 3) Patients who will accept to participate in the study.

You may not qualify if:

  • Patients with past history of Bladder Cancer with previous chemotherapy or any other types of cancer in the last 5 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut

Asyut, 71111, Egypt

Location

Related Publications (10)

  • Woldu SL, Bagrodia A, Lotan Y. Guideline of guidelines: non-muscle-invasive bladder cancer. BJU Int. 2017 Mar;119(3):371-380. doi: 10.1111/bju.13760. Epub 2017 Jan 24.

    PMID: 28058776RESULT

  • Mathew R, Karantza-Wadsworth V, White E. Assessing metabolic stress and autophagy status in epithelial tumors. Methods Enzymol. 2009;453:53-81. doi: 10.1016/S0076-6879(08)04004-4.

    PMID: 19216902RESULT

  • Kondo Y, Kanzawa T, Sawaya R, Kondo S. The role of autophagy in cancer development and response to therapy. Nat Rev Cancer. 2005 Sep;5(9):726-34. doi: 10.1038/nrc1692.

    PMID: 16148885RESULT

  • Mizushima N. Autophagy: process and function. Genes Dev. 2007 Nov 15;21(22):2861-73. doi: 10.1101/gad.1599207.

    PMID: 18006683RESULT

  • Lin YC, Lin JF, Wen SI, Yang SC, Tsai TF, Chen HE, Chou KY, Hwang TI. Inhibition of High Basal Level of Autophagy Induces Apoptosis in Human Bladder Cancer Cells. J Urol. 2016 Apr;195(4 Pt 1):1126-35. doi: 10.1016/j.juro.2015.10.128. Epub 2015 Oct 28.

    PMID: 26519656RESULT

  • Maiuri MC, Zalckvar E, Kimchi A, Kroemer G. Self-eating and self-killing: crosstalk between autophagy and apoptosis. Nat Rev Mol Cell Biol. 2007 Sep;8(9):741-52. doi: 10.1038/nrm2239.

    PMID: 17717517RESULT

  • Yang ZJ, Chee CE, Huang S, Sinicrope FA. The role of autophagy in cancer: therapeutic implications. Mol Cancer Ther. 2011 Sep;10(9):1533-41. doi: 10.1158/1535-7163.MCT-11-0047. Epub 2011 Aug 30.

    PMID: 21878654RESULT

  • Sivridis E, Koukourakis MI, Mendrinos SE, Touloupidis S, Giatromanolaki A. Patterns of autophagy in urothelial cell carcinomas--the significance of "stone-like" structures (SLS) in transurethral resection biopsies. Urol Oncol. 2013 Oct;31(7):1254-60. doi: 10.1016/j.urolonc.2011.12.016. Epub 2012 Jan 24.

    PMID: 22281431RESULT

  • Ojha R, Singh SK, Bhattacharyya S, Dhanda RS, Rakha A, Mandal AK, Jha V. Inhibition of grade dependent autophagy in urothelial carcinoma increases cell death under nutritional limiting condition and potentiates the cytotoxicity of chemotherapeutic agent. J Urol. 2014 Jun;191(6):1889-98. doi: 10.1016/j.juro.2014.01.006. Epub 2014 Jan 15.

    PMID: 24440234RESULT

  • Mukhopadhyay S, Sinha N, Das DN, Panda PK, Naik PP, Bhutia SK. Clinical relevance of autophagic therapy in cancer: Investigating the current trends, challenges, and future prospects. Crit Rev Clin Lab Sci. 2016 Aug;53(4):228-52. doi: 10.3109/10408363.2015.1135103. Epub 2016 Feb 16.

    PMID: 26743568RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Shaimaa Shakhoun

    Assiut

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MahaAli Essam-Eldeen Mohamed, lecturer

CONTACT

00201091570963mahabadari@hotmail.com

Shaimaa Shakhoun

CONTACT

00201001143867atashaimaa8@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 21, 2017

Study Start

December 1, 2020

Primary Completion

October 1, 2021

Study Completion

December 31, 2021

Last Updated

July 8, 2020

Record last verified: 2020-07

Locations

EG(1)