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Autophagy Bladder Cancer

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ClinicalTrials.gov Identifier: NCT03254888
Recruitment Status : Not yet recruiting
First Posted : August 21, 2017
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Shaimaa Ramadan, Assiut University

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 .

Condition or disease
Bladder Cancer

Detailed Description:
  • In Egypt, Bladder Cancer is the most prevalent malignancy among Egyptian males (16%) producing more than 7900 deaths annually . The majority of patients with bladder cancer about (70-80%) present with non-muscle invasive bladder cancer .
  • Autophagy is a highly conserved catabolic process that degrades cellular organelles and proteins to maintain cellular biosynthesis during stress ; cancer cells induced autophagy to counteract with anticancer therapy by helping them to evade apoptotic pathway .Autophagy is achieved by many autophagy-related genes .
  • Previous studies found that human bladder cancer cell lines exhibit high basal level of autophagic activity that may contribute to resistance to current anticancer treatment, so targeting basal autophagy may help to develop novel therapeutic strategies . Autophagy is potently induced by activating transcription factor 6(Endoplasmic Reticulum stress marker) , and Malondialdehyde (oxidative stress marker) .
  • Recently several studies demonstrated the role of autophagy in Bladder Cancer progression as evidenced by detection of microtubule associated protein and its relevance with muscle invasion beside its grade dependency . Autophagy was grade dependent process . Autophagy related gene 7 is a key protein involved in autophagosomes biogenesis, Knockdown of Autophagy related gene 7 induced apoptotic cell death in bladder cancer cell lines measured by increased caspase 3 level, Based on these previous studies autophagy plays a role in bladder cancer progression so interruption of its pathway may serve a novel target for future therapies.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Identification of Novel Autophagy Markers in Bladder Cancer Patients
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Group/Cohort
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)..



Primary Outcome Measures :
  1. autophagy marker [ Time Frame: baseline ]
    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.


Secondary Outcome Measures :
  1. stress markers [ Time Frame: baseline ]
    Relation between LC3A and muscle invasiveness in bladder cancer progression, and relation between levels of ATF6, activating transcription factor6 (ER stress marker) -MDA malondialdehyde (oxidative stress marker)-Caspase3 (apoptotic marker) in different study groups and bladder cancer development.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254888


Contacts
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Contact: MahaAli Essam-Eldeen Mohamed, lecturer 00201091570963 mahabadari@hotmail.com
Contact: Shaimaa Shakhoun 00201001143867 atashaimaa8@gmail.com

Locations
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Egypt
Assiut Not yet recruiting
Assiut, Egypt, 71111
Contact: Shaimaa Shakhoun    00201001143867    atashaimaa8@gmail.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Shaimaa Shakhoun Assiut

Publications of Results:

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Responsible Party: Shaimaa Ramadan, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03254888     History of Changes
Other Study ID Numbers: ABC
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases