Kidney Toxicity in Recurrent Epithelial Ovarian Carcinoma Patients

Background of Clinical Trial

Background of Clinical Trial 60 women with histologically-confirmed recurrent epithelial ovarian carcinoma were enrolled in this study and randomised to receive either Regimen A, B or C. Patients were required to be 18 –75 years of age, and to provide informed consent to participate in the study. At study entry, all patients were  required to have a measurable tumour documented radiologically, as well as adequate physiologic function and status (serum creatinine 0.7–1.3 mg/dL; urine volume 1.5-2.0 mg/kg/hour). The patients WHO performance status was required to be between 0-2 and expected survival ≥ 12 weeks.

Serum creatinine levels were assessed at the start of the study (baseline) and 48 hours after treatment with Regimen A, B or C. Urine volume was assessed regularly and data is given for one time point, 48 hours after chemotherapy treatment. For the purposes of this activity if a patient has a urine volume of < 0.5 mL/kg/hour at this one time point you can assume that this means they have acute kidney injury.

The key questions which the principal investigators require you to address in your report are:-

1) Were the baseline characteristics of the patients the same between the patients randomised to Regimen A, B or C?

2) What proportion of patients have acute kidney injury? Does this differ by regimen?

3) Does treatment with Regimen A, B, or C lead to a difference in serum creatinine levels and urine output?

4) What relationship exists, if any, between serum creatinine and urine output in the ovarian cancer patients?

5) Which regimen is the most appropriate treatment? Which regimen is the least appropriate? Why?

Your task

You a required to produce a coherent, concise, well presented and well-structured report which informs the principal investigators whether or not there is genuine evidence of difference in the kidney toxicity caused by Regimen A, B and C in the treatment of recurrent ovarian cancer patients. Further, you are required to report on whether there is any association between the serum creatinine levels and urine output.

This assignment has two parts:

1) An executive summary where you introduce the topic, present your analysis with supporting graphs and your conclusions. This is in the style of a mini lab report. Please see the rubric for how the sections will be marked. Graphs in this section should be made in Graphpad Prism. You cannot assume that the principal investigators understand statistical methods in detail and you will therefore have to summarise your findings in plain non-technical language.

2) A statistical report where you explain in detail which statistical tests you performed and your reasoning for choosing them.

The report should be a maximum of 6 pages it’s up to you how much to include in each of the above sections. However, be aware of the marking rubric so you know how many marks each section is worth. Minimum font size 11 Calibri. The reference List is not included in the page count. A cover page and table of contents are not required.

You are expected to:

• Introduce the problem and the questions being addressed. You need to cite and reference any materials you use.
• Please note this is not an opportunity for the MSc Clinical Biochemistry students to show off how much they know about creatinine. You need to introduce the topic properly but this is a statistics assignment. Students on all MSc programs can analyse this data with only a small amount of additional reading on the topic to complete their report!
• Present key graphs only for understanding the data – not every graph you produced in Minitab while analysing the dataset. This is why there is a page count rather than a word count for the assignment. Only include graphs which you fully format, label, and discuss in the text.
• Describe briefly the statistical tests you used and your justification for using them.
• Interpret and report the results of these tests correctly.
• Briefly discuss the results and formulate a conclusion, which may involve critiquing the original questions asked by the principal investigators and / or the methodology.
• Only report the appropriate statistical methods not how to operate Minitab.
• Be sure to cite and reference all materials according to University Guidelines – Harvard Cite

Them Right Format – See video on the module page in the assessment folder.