The primary objective is to get a comprehensive insight in the role of body composition features in RCC, and how these are related to patient-, tumour- and lifestyle-related factors, circulating biomarkers, and recurrence and survival.The research…
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoints are cross-sectional area and mean radiodensity of SM,
VAT, and APF at baseline.
The main study parameters are patient and tumour characteristics, dietary and
physical activity habits, and circulating concentrations of biomarkers (in
total 18 parameters, e.g. age, sex, tumour stage, and energy intake).
Secondary outcome
Secondary study endpoints are cross-sectional areas and mean radiodensity of
SAT, IMAT, and TAT at baseline, cross-sectional areas and mean radiodensity of
all body composition features at follow-up, and changes in cross-sectional
areas and mean radiodensity of all body composition features per year.
Secondary study parameters are other patient and tumour characteristics,
dietary and physical activity habits, and circulating concentrations of
biomarkers.
Background summary
In the Netherlands, over 2300 men and women are diagnosed with renal cell
cancer (RCC) annually.
Excess body weight, expressed as body mass index (BMI) >=25 kg/m2, is an
important risk factor for RCC. More than 60% of RCC patients present with
excess body weight and suffer from obesity-related comorbidities. In contrast,
excess body weight has been associated with improved recurrence-free,
cancer-specific, and overall survival in RCC patients.
However, BMI cannot distinguish between amount and quality of adipose tissue
and skeletal muscle (SM), nor between visceral (VAT) and subcutaneous adipose
tissue (SAT) and adherent perinephric fat (APF). In patients with other cancer
types, recent studies showed that preoperative low SM mass, low SM quality, and
high VAT mass were better predictors of prognosis than BMI. And that these were
associated with worse overall survival, independent of BMI. Potential
mechanisms underlying this association are unfavourable circulating
concentrations of VAT-derived pro-inflammatory and pro-tumorigenic adipokines
(e.g. adiponectin, leptin). These molecules have been associated with a
low-grade systemic inflammation and with worse overall survival in these
patients.
We hypothesize that body composition features better predict RCC prognosis than
BMI, and are potential targets for tertiary prevention. To date, this has not
been adequately studied. In order to develop tertiary prevention trials for RCC
patients, we need to get a comprehensive insight in the role of body
composition features in RCC, and how these are related to patient-, tumour- and
lifestyle-related factors, circulating biomarkers, and recurrence and survival.
Our ultimate aim is to provide RCC patients with personalized advice about
weight management to improve their prognosis.
Study objective
The primary objective is to get a comprehensive insight in the role of body
composition features in RCC, and how these are related to patient-, tumour- and
lifestyle-related factors, circulating biomarkers, and recurrence and survival.
The research questions include:
1. Are patient and tumour characteristics associated with body composition
features in RCC?
2. What are the lifestyle habits of RCC patients, and are they associated with
body composition features?
3. Are circulating adipokines associated with body composition features in RCC?
4. Are body composition features associated with cancer recurrence and survival
in RCC, and is this association independent of BMI?
Study design
To answer the research questions, a prospective cohort study will be conducted.
Participants will be asked twice (~4 months and ~10 months after diagnosis):
- to fill in questionnaires (general, diet, physical activity)
- to wear an accelerometer (7 days)
- to donate blood in their own hospital. We will try to organize the blood
collection at the same time as the follow-up appointments, so participants do
not need to visit the hospital an extra time.
CT scans will be obtained from the treating physicians. Relevant information on
clinical data (e.g. tumour characteristics, surgery, therapy) will be obtained
from the medical files and the NCR.
To answer research questions 1 and 4, also a historical cohort study will be
conducted. For that study, which does not fall under the WMO, another protocol
has been written which has been approved by CMO Arnhem-Nijmegen [CMO 2015-1822
].
Study burden and risks
This study does not involve any clinical treatment or intervention. The only
risks associated with participation in this study are confined to the normal
risks of taking blood samples (risk of fainting and of bruising). Since the
drawing of blood will be done by professionals, risks are low. The burden for
participants includes, at two time points: 1) filling out a general
questionnaire and a questionnaire about dietary intake (estimated time required
about 1,5-2 hours per time point), 2) wearing an accelerometer for 7
consecutive days, and 3) donating blood samples. This study can therefore be
classified as a negligible risk study (negligible risk of harm and negligible
severity of harm).
Geert Grooteplein Noord 21
Nijmegen 6525 EZ
NL
Geert Grooteplein Noord 21
Nijmegen 6525 EZ
NL
Listed location countries
Age
Inclusion criteria
- Stage I-III RCC, diagnosed from 2017
- Aged between 18 and 75 years at diagnosis
- Able to communicate in Dutch, to read and understand the patient information and informed consent form
- Able to fill out questionnaires, and to visit the hospital to donate blood samples
Exclusion criteria
Patients diagnosed with another type of cancer in the 5 years before RCC diagnosis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59329.091.16 |