Clinical trial NCT00718367: Correlation of the Clinical Behaviour of Renal Cell Carcinoma (RCC) After Debulking Nephrectomy With Tumor Gene Expression in Nephrectomy Specimens
Official title: Correlation of the Clinical Behaviour of Renal Cell Carcinoma (RCC) After Debulking Nephrectomy With Tumor Gene Expression in Nephrectomy Specimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2008-07-18
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced RCC who had a cytoreductive nephrectomy done. Patients did not receive specific anti-cancer systemic therapy after the nephrectomy, except after clinical disease progression. Tumor samples available.

Brief summary: The objective of the study is to determine whether a specific immune microenvironment in the primary tumor is associated with a favorable clinical course after nephrectomy and in the absence of adjuvant treatment.

Detailed description: Renal cell carcinoma (RCC) is a tumor with clinically apparent immunologic phenomena, such as response to immunotherapies (interferon, interleukin-2, immune cellular therapy etc), spontaneous regression, and sometimes indolent behaviour. Nephrectomy itself influences the prognosis of advanced RCC patients as shown in 2 randomised trials, and could have an immune basis. We previously reported on the variability of clinical behaviour in advanced RCC patients who had not received systemic treatment after debulking nephrectomy (Debulking Nephrectomy Followed By A "Watch And Wait" Approach In Metastatic Renal Cell Carcinoma .Wong A, et al. Urol Oncol, in press). The clinical significance of this includes the avoidance of toxic systemic therapies after nephrectomy, or the possibility of using non-toxic vaccine approaches in metastatic patients after cytoreductive nephrectomy. In this research proposal we would like to analyse the immune related gene expression profile on nephrectomy tumor samples and correlate them with the clinical course of the patient after the nephrectomy. This will be an exploratory and retrospective study of 15 patients in whom debulking nephrectomy for advanced RCC had been done, who did not receive any adjuvant treatment, and in whom the clinical course had been monitored after the nephrectomy.

We will first carry out a feasibility study during which we will isolate RNA from 3 FFPE (formalin-fixed,paraffin-embedded) samples using commercially available RNA isolation kit and we will determine if their quality is compatible with quantitative polymerase chain reaction (qPCR) or microarray studies. Upon successful feasibility study, the analysis will be extended to 15 patients. RNA will be isolated from FFPE samples and the gene expression profiles will be evaluated by qPCR and/or microarray. Emphasis will be placed on the expression profile of immune-related genes. Finally, transcriptome analysis results will be extended at the protein and cell level using immunohistochemistry assays.

Eligibility criteria: Inclusion Criteria:

* Advanced RCC who had a cytoreductive nephrectomy done.
* Patients did not receive specific anti-cancer systemic therapy after the nephrectomy, except after clinical disease progression.
* Tumor samples available.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Alvin Seng Cheong Wong, MRCP, MB ChB
role: PRINCIPAL_INVESTIGATOR
affiliation: Tan Tock Seng Hospital
name: Sing Joo Chia
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kondo T, Nakazawa H, Ito F, Hashimoto Y, Osaka Y, Futatsuyama K, Toma H, Tanabe K. Favorable prognosis of renal cell carcinoma with increased expression of chemokines associated with a Th1-type immune response. Cancer Sci. 2006 Aug;97(8):780-6. doi: 10.1111/j.1349-7006.2006.00231.x.