We aim to identify diagnostic serum metabolite and protein biomarker signatures for early detection of cancer in asymptomatic high-risk population and prognostic biomarkers for selection of patients with poor prognosis.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical data (via a case report form) and epidemiological data (via a
questionnaire) will be collected prospectively. Blood samples will be taken
before treatment. In case of hysterectomy, an endometrial biopsy will be
collected for immunohistochemical marker analyses.
Blood metabolome comprising over 850 metabolites will be analysed by UHPLC/MS,
ESI/MS/MS (e.g. chromatography tandem mass spectrometry). Blood proteome
including 900 different cancer-related proteins will be analysed in parallel
using high content antibody microarrays.
Bioinformatics/biostatistical analysis will be used to derive diagnostic and
prognostic algorithms based on blood metabolites, proteins and clinical data.
Algorithms in the biomarker discovery study will be developed by comparing EC
and patients with benign uterine pathologies and by comparing EC patients with
low risk and high risk for cancer progression and recurrence.
Secondary outcome
Not Applicable
Background summary
Endometrial cancer (EC) is the most frequent gynaecological malignancy in the
developed world. Optimal treatment of EC depends on early diagnostics and
pre-operative stratification to appropriately select the extent of surgery and
to plan further therapeutic approach. Currently, invasive endometrial histology
is the gold standard for diagnosis, as there are no valid non-invasive methods
available, and patient stratification is based on histopathology and surgical
findings. There is a great need for efficient and reliable screening test for
asymptomatic women with high risk of EC including Lynch syndrome patients and
tamoxifen treated patients. In addition, a prognostic test is needed to
stratify pre-operatively EC patients with high risk of progression in need of
radical surgery together with adjuvant chemo/ratio therapy from EC patients
with good prognosis. In our project we are addressing this lack of non-invasive
diagnostic and prognostic biomarkers of EC.
Study objective
We aim to identify diagnostic serum metabolite and protein biomarker signatures
for early detection of cancer in asymptomatic high-risk population and
prognostic biomarkers for selection of patients with poor prognosis.
Study design
Prospective observational case / control study. Serum from women diagnosed with
EC (200) and controls (200) will be analysed using non-targeted and targeted
metabolomics and semi-targeted proteomics approaches. Subjects will also fill a
life-style questionnaire.
Study burden and risks
The burden for subjects enrolled is minimal, being the only intervention a
blood sampling (10 mL) and giving information about life-style via a
questionnaire. The expected benefits are the discovery of diagnostic biomarker
signatures for early diagnosis and for development of screening test, and the
discovery of prognostic biomarkers for pre-surgical selection of EC patients
with poor prognosis. Thus, this would lead to early diagnosis of EC
non-invasively and improved treatment outcomes for the high-risk patients,
likely decreasing the cases of under and over treatment. Thus the balance
benefits / burdens is positive.
P Debyelaan 25
Maastricht 6229 HX
NL
P Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Cases:
- Being older than 18 year
- Diagnosis of endometrial cancer (endometrioid, serous, clear cell or mucinous; dedifferentiated; high grade or low grade)
- Patients must have signed an approved informed consent;Controls:
- Being older than 18 year
- Being diagnosed with a benign gynaecological disease, e.g. myoma uteri, prolapsed uterus, or undergoing hysterectomy as prophylactic measure (Lynch syndrome)
- Controls will be enrolled if they are-matched with cases (benign disorders may occur more frequently than EC at young age
- Subjects must have signed an approved informed consent
Exclusion criteria
Cases:
- Being younger than 18 year
- Diagnosis of atypical hyperplasia, other types of cancer, sarcoma uteri
- Previous diagnosis of EC
- Being pregnant at the moment of enrollment
- Inability to approve the informed consent form;Controls:
- Being younger than 18 year
- Being diagnosed with a benign ovarian diseases
- Being diagnosed with any malignancy
- Previous diagnosis of EC
- Being pregnant at the moment of enrollment
- Inability to approve the informed consent form
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 | NL63773.068.17 |