The primary objective of this study is to compare the profile of MicroRNA*s in the urine and blood of lung cancer patients with the profile of MicroRNA*s in the urine and blood of non-lung cancer patients with similar symptoms and with that of…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are microRNA sequencing data (read-counts per
microRNA) derived from next generation
sequencing of the small RNA fractions of blood and urine. The sequencing data
will be correlated to clinical parameters:
diagnosed with lung cancer (CT, histopathology), suspected of having lung
cancer but not diagnosed (CT, possibly histopathology),
not-suspected of lung cancer or any other disease.
Secondary outcome
Measurements of volatile organic compounds (VOCs) resulting from the electronic
nose technology. With the primary outcomes and the secondary outcomes a
predictive model will be developed to predict the probability for having lung
cancer.
Background summary
microRNAs regulate the expression of multiple genes to control cellular
processes. They are generally involved in maintaining homeostasis. There are
~2500 microRNAs and their expression profile changes with the onset of
disease. For instance specific microRNAs are higher or lower expressed in
specific types of tumors, dilated hearts and activated immune cells. MicroRNAs
are secreted by cells into the circulation and disease-associated microRNAs can
thus be found in body fluids such as blood and urine. Based on these facts, it
is our hypothesis that the microRNA profiles in blood and urine can be used as
a personalized monitoring system of health to detect the presence of lung
cancer.
Study objective
The primary objective of this study is to compare the profile of MicroRNA*s in
the urine and blood of lung cancer patients with the profile of MicroRNA*s in
the urine and blood of non-lung cancer patients with similar symptoms and with
that of healthy volunteers.
Key questions to be answered by this study are:
-> Can lung Can lung cancer- associated microRNAs can be found at elevated
levels in the urine of patients?
-> Are lung cancer-associated microRNA profiles in urine similar to lung
cancer-associated microRNA profiles in blood?
-> Are urine and/or blood reliable sources of microRNAs for the diagnosis of
lung cancer. Which of the microRNA profiles (blood or urine) has the better
diagnostic value.
Study design
Pilot study in maximal 75 patients suspected of lung cancer and 25 healthy
volunteers.
Study burden and risks
Volunteers are asked to collect one urine sample (50ml) and one blood sample of
10 ml. There are no known risks
associated with urine collection. There are some known risks or adverse effects
to blood sample collection like
hematoma which can cause discomfort and pain. The overall burden for subjects
is considered low in this study.
Drienerloolaan 5
Enschede 7522NB
NL
Drienerloolaan 5
Enschede 7522NB
NL
Listed location countries
Age
Inclusion criteria
maximal 75 patients with a suspicion of lung cancer (in order to obtain 25 patients with lungcancer stage 3 / 4 and 25 patients with a negative diagnosis)
- between 45-80 years of age
Exclusion criteria
Patients; known other than lung cancer malignity, urinary tract infection
Controls: known other than lung cancer malignity, no suspicion of lung cancer malignicy, pneumonia, urinary tract infection
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 | NL64386.044.18 |