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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04525781
Other study ID # Urinary bladder cancer.
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2020
Est. completion date December 2021

Study information

Verified date August 2020
Source Assiut University
Contact Rehab Osama Abdelmoboud
Phone 01064482770
Email Rehabosama620@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date December 2021
Est. primary completion date October 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- age 18 :70

- Histologically proved urinary bladder carcinoma

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (11)

Chen 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. — View Citation

Dobruch 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. Review. — View Citation

Ferlay 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. — View Citation

Golka K, Wiese A, Assennato G, Bolt HM. Occupational exposure and urological cancer. World J Urol. 2004 Feb;21(6):382-91. Epub 2003 Nov 26. Review. — View Citation

Jemal 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. Erratum in: CA Cancer J Clin. 2005 Jul-Aug;55(4):259. — View Citation

Lynch CF, Cohen MB. Urinary system. Cancer. 1995 Jan 1;75(1 Suppl):316-29. — View Citation

Malats 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. Review. — View Citation

Murta-Nascimento C, Schmitz-Dräger 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. Review. — View Citation

Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. — View Citation

Shokeir AA. Squamous cell carcinoma of the bladder: pathology, diagnosis and treatment. BJU Int. 2004 Jan;93(2):216-20. Review. — View Citation

Zhao 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. Review. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline
Secondary Survival in bladder cancer in different stages baseline
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