Urinary Bladder CancerNCT04525781
Clinicoepidimiological Study and Clinical Outcome in Patients With Urinary Bladder Cancer
An observational study of Urinary Bladder Cancer, run by Assiut University.
Trial summary
To pinpoint the clinical ,epidimiological factors and clinical outcomes in urinary bladder cancer patients attending to our department during 5 years period between 2015-2019. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Urinary Bladder Cancer
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: study initialy including about 150 patients with urinary bladder cancer.
Who may be able to join
- age 18 :70
- Histologically proved urinary bladder carcinoma
Who cannot join
- Age less than 18 or more than 70
- Patient not documented having bladder carcinoma with biopsy [cysyoscopic or operative]
- Patient with synchronous or metachronous double primary
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinicoepidimiological Study and Clinical Outcome in Patients With Urinary Bladder Cancer at Assuit University Hospital From 2015 to 2019(Hospital Based Study)
To pinpoint the clinical ,epidimiological factors and clinical outcomes in urinary bladder cancer patients attending to our department during 5 years period between 2015-2019.
Read the detailed description
Bladder cancer is the ninth most common cancer throughout the world. The incidence of bladder cancer is three to four times greater in men than in women. However, women are diagnosed with more advanced disease at presentation and have less favorable outcomes after treatment. Statistical data show that between 2002 and 2012, worldwide, the number of bladder cancers increased from 375.000 to about 430.000 , while the mortality increased from 145.000 patients in 2002 up to 165.000 patients in 2012. In the United States, bladder cancer is the fourth most common cancer in males with an age-adjusted incidence rate of 37.3/100,000 person years (PY) using the US standard population.
In developed countries, over 90% of the bladder cancer cases diagnosed are transitional cell carcinoma (TCC), with squamous cell carcinoma (SCC), adenocarcinomas, and rare types of bladder cancer comprising the remaining 10% of bladder cancer cases.
Exposures to tobacco smoke, occupational toxins, and environmental sources of heavy metals such as arsenic are the major reported risk factors for TCC.
Unlike TCC, the main risk factors for SCC are not environmental exposures, but exposure to infectious agents. Age, smoking, tumor stage and the treatment modalities such as surgery and adjuvant chemotherapy were proved to affect the overall survival in patients with urinary bladder cancer. Our study may give an important evidence about clinical, epidemiological factors and clinical outcomes in urinary bladder cancer patients at Assuit University Hospital.
- Conditions
- Urinary Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of response in non muscle invasive,muscle invasive and metastatic bladder cancer.
Analysis of patients data including risk factors and treatment and detection of response in each stage.
Measured: baseline
Secondary outcomes (1)
Survival in bladder cancer in different stages
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study startOct 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Osama Abdelmaboud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525781
- Sponsor's protocol ID
- Urinary bladder cancer.
- Status last verified
- Aug 2020
- First submitted
- 20 Aug 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.
PubMed 15761078Dobruch J, Daneshmand S, Fisch M, Lotan Y, Noon AP, Resnick MJ, Shariat SF, Zlotta AR, Boorjian SA. Gender and Bladder Cancer: A Collaborative Review of Etiology, Biology, and Outcomes. Eur Urol. 2016 Feb;69(2):300-10. doi: 10.1016/j.eururo.2015.08.037. Epub 2015 Sep 4.
PubMed 26346676Murta-Nascimento C, Schmitz-Drager BJ, Zeegers MP, Steineck G, Kogevinas M, Real FX, Malats N. Epidemiology of urinary bladder cancer: from tumor development to patient's death. World J Urol. 2007 Jun;25(3):285-95. doi: 10.1007/s00345-007-0168-5.
PubMed 17530260Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
PubMed 25220842Malats N, Real FX. Epidemiology of bladder cancer. Hematol Oncol Clin North Am. 2015 Apr;29(2):177-89, vii. doi: 10.1016/j.hoc.2014.10.001.
PubMed 25836927Zhao M, He XL, Teng XD. Understanding the molecular pathogenesis and prognostics of bladder cancer: an overview. Chin J Cancer Res. 2016 Feb;28(1):92-8. doi: 10.3978/j.issn.1000-9604.2016.02.05.
PubMed 27041931Jemal A, Murray T, Ward E, Samuels A, Tiwari RC, Ghafoor A, Feuer EJ, Thun MJ. Cancer statistics, 2005. CA Cancer J Clin. 2005 Jan-Feb;55(1):10-30. doi: 10.3322/canjclin.55.1.10.
PubMed 15661684Lynch CF, Cohen MB. Urinary system. Cancer. 1995 Jan 1;75(1 Suppl):316-29. doi: 10.1002/1097-0142(19950101)75:1+3.0.co;2-t.
PubMed 8001003Golka K, Wiese A, Assennato G, Bolt HM. Occupational exposure and urological cancer. World J Urol. 2004 Feb;21(6):382-91. doi: 10.1007/s00345-003-0377-5. Epub 2003 Nov 26.
PubMed 14648102Chen CJ, Chuang YC, You SL, Lin TM, Wu HY. A retrospective study on malignant neoplasms of bladder, lung and liver in blackfoot disease endemic area in Taiwan. Br J Cancer. 1986 Mar;53(3):399-405. doi: 10.1038/bjc.1986.65.
PubMed 3964542Shokeir AA. Squamous cell carcinoma of the bladder: pathology, diagnosis and treatment. BJU Int. 2004 Jan;93(2):216-20. doi: 10.1111/j.1464-410x.2004.04588.x.
PubMed 14690486
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinicoepidimiological Study and Clinical Outcome in Patients With Urinary Bladder Cancer at Assuit University Hospital From 2015 to 2019(Hospital Based Study)
- ClinicalTrials.gov ID
- NCT04525781
- Acronym / sponsor ID
- Urinary bladder cancer.
- Conditions
- Urinary Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To pinpoint the clinical ,epidimiological factors and clinical outcomes in urinary bladder cancer patients attending to our department during 5 years period between 2015-2019.
Detailed description
Bladder cancer is the ninth most common cancer throughout the world. The incidence of bladder cancer is three to four times greater in men than in women. However, women are diagnosed with more advanced disease at presentation and have less favorable outcomes after treatment. Statistical data show that between 2002 and 2012, worldwide, the number of bladder cancers increased from 375.000 to about 430.000 , while the mortality increased from 145.000 patients in 2002 up to 165.000 patients in 2012. In the United States, bladder cancer is the fourth most common cancer in males with an age-adjusted incidence rate of 37.3/100,000 person years (PY) using the US standard population.
In developed countries, over 90% of the bladder cancer cases diagnosed are transitional cell carcinoma (TCC), with squamous cell carcinoma (SCC), adenocarcinomas, and rare types of bladder cancer comprising the remaining 10% of bladder cancer cases.
Exposures to tobacco smoke, occupational toxins, and environmental sources of heavy metals such as arsenic are the major reported risk factors for TCC.
Unlike TCC, the main risk factors for SCC are not environmental exposures, but exposure to infectious agents. Age, smoking, tumor stage and the treatment modalities such as surgery and adjuvant chemotherapy were proved to affect the overall survival in patients with urinary bladder cancer. Our study may give an important evidence about clinical, epidemiological factors and clinical outcomes in urinary bladder cancer patients at Assuit University Hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- study initialy including about 150 patients with urinary bladder cancer.
Key inclusion criteria (2 listed)
- age 18 :70
- Histologically proved urinary bladder carcinoma
Key exclusion criteria (3 listed)
- Age less than 18 or more than 70
- Patient not documented having bladder carcinoma with biopsy [cysyoscopic or operative]
- Patient with synchronous or metachronous double primary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
comparison of response in non muscle invasive,muscle invasive and metastatic bladder cancer.
Time frame: baseline
Analysis of patients data including risk factors and treatment and detection of response in each stage.
1 secondary outcome
Survival in bladder cancer in different stages
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Background: PubMed 15761078Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.
- Background: PubMed 26346676Dobruch J, Daneshmand S, Fisch M, Lotan Y, Noon AP, Resnick MJ, Shariat SF, Zlotta AR, Boorjian SA. Gender and Bladder Cancer: A Collaborative Review of Etiology, Biology, and Outcomes. Eur Urol. 2016 Feb;69(2):300-10. doi: 10.1016/j.eururo.2015.08.037. Epub 2015 Sep 4.
- Background: PubMed 17530260Murta-Nascimento C, Schmitz-Drager BJ, Zeegers MP, Steineck G, Kogevinas M, Real FX, Malats N. Epidemiology of urinary bladder cancer: from tumor development to patient's death. World J Urol. 2007 Jun;25(3):285-95. doi: 10.1007/s00345-007-0168-5.
- Background: PubMed 25220842Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
- Background: PubMed 25836927Malats N, Real FX. Epidemiology of bladder cancer. Hematol Oncol Clin North Am. 2015 Apr;29(2):177-89, vii. doi: 10.1016/j.hoc.2014.10.001.
- Background: PubMed 27041931Zhao M, He XL, Teng XD. Understanding the molecular pathogenesis and prognostics of bladder cancer: an overview. Chin J Cancer Res. 2016 Feb;28(1):92-8. doi: 10.3978/j.issn.1000-9604.2016.02.05.
- Background: PubMed 15661684Jemal A, Murray T, Ward E, Samuels A, Tiwari RC, Ghafoor A, Feuer EJ, Thun MJ. Cancer statistics, 2005. CA Cancer J Clin. 2005 Jan-Feb;55(1):10-30. doi: 10.3322/canjclin.55.1.10.
- Background: PubMed 8001003Lynch CF, Cohen MB. Urinary system. Cancer. 1995 Jan 1;75(1 Suppl):316-29. doi: 10.1002/1097-0142(19950101)75:1+3.0.co;2-t.
- Background: PubMed 14648102Golka K, Wiese A, Assennato G, Bolt HM. Occupational exposure and urological cancer. World J Urol. 2004 Feb;21(6):382-91. doi: 10.1007/s00345-003-0377-5. Epub 2003 Nov 26.
- Background: PubMed 3964542Chen CJ, Chuang YC, You SL, Lin TM, Wu HY. A retrospective study on malignant neoplasms of bladder, lung and liver in blackfoot disease endemic area in Taiwan. Br J Cancer. 1986 Mar;53(3):399-405. doi: 10.1038/bjc.1986.65.
- Background: PubMed 14690486Shokeir AA. Squamous cell carcinoma of the bladder: pathology, diagnosis and treatment. BJU Int. 2004 Jan;93(2):216-20. doi: 10.1111/j.1464-410x.2004.04588.x.
- Surveillance Epidemiology End Results. Cancer Stat Facts SheetLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rehab Osama Abdelmoboud (01064482770, Rehabosama620@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of response in non muscle invasive,muscle invasive and metastatic bladder cancer. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04525781, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.