CHAPTER SEVEN 7.0 CONCLUSION AND RECOMMENDATIONS 7.1 CONCLUSION
Urinary markers, BTA and Survivin, have sensitivity and specificity of 98.9%, 98.9% and 13.6%, 4.5% respectively while their positive and negative predictive values (PPV and NPV) were 81.7%, 80.2% and 75.0%, 50.0% respectively. They are therefore effective in the diagnosis of bladder carcinoma. Survivin and BTA correlated with grade and stage of bladder carcinoma respectively. There were high false positive results (100%) in patients with haematuria from other urologic conditions and patients with benign prostatic hyperplasia.
The commonest histopathological type of bladder carcinoma in the present study was squamous cell type which was found in 59.5% of patients. Other histopathological types were transitional cell carcinoma and adenocarcinoma in 38.1% and 2.4% of patients respectively.
4. The markers should not be used alone in patients with haematuria from other urologic conditions. This is due to high false positive results which can be as high as 100%.
5. There is need to establish reference values for these markers in our environment for healthy volunteers, bladder carcinoma, other urologic malignancies and benign genito-urinary conditions.
6. There is need for large and long term multicentre randomised control trials in our environment to determine clearly the effectiveness of BTA and Survivin in the diagnosis of bladder carcinoma.
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APPENDIX A ETHICAL APPROVAL
APPENDIX B INFORMED CONSENT
My name is Dr. Abubakar Sadiq Muhammad, a senior registrar in urology division, department of surgery, Usmanu Danfodiyo University Teaching Hospital, Sokoto. I am carrying out a research on the effectiveness of urinary molecular markers (BTA TRAK, Survivin) in diagnosis of bladder cancer under supervision of Prof. Mungadi with assistance from other Doctors in his team, in the urology unit, department of surgery, Usmanu Danfodiyo University Teaching Hospital, Sokoto.
Purpose of research:
To find out the effectiveness of urinary molecular markers the diagnosis of bladder cancer.
Procedure of the research:
All Patients under urology care being investigated for bladder cancer that satisfies the inclusion criteria will be recruited for the study. Urine sample will be taken for cytology and assays for molecular markers. Cystoscopy and biopsy will then be done under regional or general anaesthesia by competent doctors. The tissue will be examined by a histopathologist for diagnosis. We are expected to recruit at least 50 patients in 12 months. You will be informed of the result of the research during your follow up or by communicating through your contact if need arises.
Risks:
Urinary markers assay is harmless. In cystoscopy and biopsy there might be discomfort, pain and bleeding which are self-limiting. You may have urinary tract infection, urethral stricture if urethra is traumatised. Precautions will be taken to avoid that. We have not witness bothersome complications in the past. In case of any complication the hospital will take full responsibility of your treatment.
Cost to the participant of joining the research:
Your participation in this research will not cost you additional expenses other than that of your normal care. For healthy volunteers it will not cost anything.
Benefits:
It will guide and corroborate your cystoscopy and biopsy findings. After curative treatment urinary markers can be used for follow up to reduce number and cost of cystoscopies. It can be used to screen your family or community with significant risk for development of bladder carcinoma.
Confidentiality:
Your name will not be used in the results or reports from this study.
Voluntariness:
Your participation is entirely voluntary. You may withdraw at any time of the study it will not affect your treatment in this hospital.
Conflict of interest:
There is none to declare.
Statement of person giving informed consent:
I have read the description of the research or have had it translated into language I understand. I have also talked it over with my doctor to my satisfaction. I understand that my participation is voluntary. I know enough about the purpose, methods, risks and benefits of the research to judge that I want to take part in it. I understand that I may freely stop being part of this research at any time.
Name...Date...
.
Signature...
Witness...sign ...Date...
APPENDIX C PRO FORMA
(A) BIODATA
Name... Age... Hospital no...
Sex... Marital status... Occupation...
Address... Phone number...
(B) HISTORY
Haematuria LUTS Necroturia Lower abdominal swelling Weight loss Anorexia
Drugs- cyclophosphamide, analgesic abuse Risk -
Schistosomiasis Smoking Others
(C) EXAMINATION
Pallor Cachexia DRE- prostate enlargement Abdomen- bladder mass
(D)
(E) INVESTIGATIONS
Urine – analysis MCS
Blood- FBC PSA Radiology – abdominal USG Others
(F) CYSTOSCOPY + BIOPSY
Cystoscopy Biopsy
(G) DIAGNOSIS / GRADE Positive Histological TCC SCC Others
Grade (WHO 1973) I II III (H) Comparison of Histological diagnosis with Urine molecular markers
Negative Positive Histology
TCC SCC
Others
Cytology (atypical, suspicious, positive) BTA TRAK
Survivin