Endometrial CancerBioEndoCarNCT03553589
Biomarkers for Diagnosis and Prognosis of Endometrial Carcinoma
An observational study of Endometrial Cancer, run by Andrea Romano at 5 sites in 3 countries.
Trial summary
Endometrial cancer (EC) is the most frequent gynecological malignancy but there is currently lack of both non-invasive diagnostic tools and novel markers to stratify patients based on their risk of future recurrence. Patient care could be improved by advances in these two aspects. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Blood sampling
- How many people
- 400 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 1 Oct 2018to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women older than 18 years and able to sign the informed consent.
Who may be able to join
- endometrioid, serous, clear cell or mucinous endometrial cancer
- dedifferentiated endometrial cancer
- high grade or low grade endometrial cancer
- benign uterine diseases, e.g. myoma uteri, prolapsed uterus
- prophylactic hysterectomy for Lynch syndrome
Who cannot join
- atypical hyperplasia
- other types of cancer
- sarcoma uteri
- previous diagnosis of endometrial cancer
- any cancer
- benign ovarian diseases
- previous EC
- pregnancy at the time of enrollment
Trial locations and contacts
5 sites in 3 countries.
Roy Kruitwagen, Prof. Dr. contact
5 sites in 3 countries
Netherlands2 sites, 2 recruiting
- Recruiting
Maastricht University Medical Centre
Maastricht
Andrea Romano, dr., +31 43 3881286, a.romano@maastrichtuniversity.nl
Roy Kruitwagen, Prof. dr.
- Not yet recruiting
Maxima Medical Centre
Veldhoven
Marlies Bongers, Prof. dr.
Slovenia2 sites, 2 recruiting
- Not yet recruiting
Faculty of Medicine, University of Ljubljana
Ljubljana
Tea Lanišnik Rižner, Prof. dr., +386 1543 7657, tea.lanisnik-rizner@mf.uni-lj.si
- Recruiting
University Medical Centre, Ljubljana
Ljubljana
Špela Smrkolj, Prof. Dr., spela.smrkolj@kclj.si
Poland1 site, 1 recruiting
- Recruiting
Lublin Medical University
Lublin
Andrzej Semczuk, Prof, +48 81 7244262, andrzej.semczuk@umlub.pl
About this study
Official title: Minimally and Non-invasive Methods for Early Detection and Progression of Endometrial Cancer
Endometrial cancer (EC) is the most frequent gynecological malignancy but there is currently lack of both non-invasive diagnostic tools and novel markers to stratify patients based on their risk of future recurrence. Patient care could be improved by advances in these two aspects.
In the present study, the investigators 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.
Read the detailed description
Rationale: 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 this project the investigators are addressing this lack of non-invasive diagnostic and prognostic biomarkers of EC.
Objective: the investigators aim to identify diagnostic serum metabolite and protein biomarker signatures for early detection of cancer in asymptomatic high-risk population and (secondary objective) prognostic biomarkers for selection of patients with poor prognosis.
- Conditions
- Endometrial Cancer
- Being tested
- Blood sampling
- Keywords
- metabolomics, proteomics, early diagnosis, prognosis
- Medical subject headings
- Endometrial Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Blood sampling (10 mL) prior to standard care (e.g. surgery, medical treatment)
| Study group | Role | What they receive |
|---|---|---|
| Cases | Women older than 18 years and diagnosed with endometrial cancer will be included. Blood sampling will be performed on all subjects and will be used for proteomics and metabolomics analyses. Receives: Other: Blood sampling | |
| controls | Women older than 18 years and with a benign endometrial disturbance will be included. Blood sampling will be performed on all subjects and will be used for proteomics and metabolomics analyses. Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a diagnostic algorithm
Blood metabolome and proteome will be analysed and bioinformatics/biostatistical analysis will be used to derive diagnostic 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.
Measured: 2020-2021
Secondary outcomes (1)
Creation of a prognostic algorithm
Blood metabolome and proteome will be analysed and bioinformatics/biostatistical analysis will be used to derive prognostic algorithms based on blood metabolites, proteins, clinical data at baseline and follow up information. Algorithms in the biomarker discovery study will be developed by comparing EC patients with low risk and high risk for cancer progression and recurrence.
Measured: 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start1 Oct 2018
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrea Romano
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine, Medical University of Lublin
- Responsible party
- Sponsor-investigator, Andrea Romano, Academisch Ziekenhuis Maastricht
- Investigators
- Andrea Romano, Principal investigator, Maastricht University Medical CentreTea Lanišnik Rižner, Prof. Dr., Study chair, Faculty of Medicine, University of Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553589
- Sponsor's protocol ID
- NL63773
- Acronym
- BioEndoCar
- Status last verified
- Dec 2018
- First submitted
- 30 May 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be discussed within the team, put planned
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally and Non-invasive Methods for Early Detection and Progression of Endometrial Cancer
- ClinicalTrials.gov ID
- NCT03553589
- Acronym / sponsor ID
- BioEndoCar / NL63773
- Conditions
- Endometrial Cancer
- Keywords
- metabolomics, proteomics, early diagnosis, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Andrea RomanoUniversity, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine, Medical University of Lublin
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endometrial cancer (EC) is the most frequent gynecological malignancy but there is currently lack of both non-invasive diagnostic tools and novel markers to stratify patients based on their risk of future recurrence. Patient care could be improved by advances in these two aspects.
In the present study, the investigators 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.
Detailed description
Rationale: 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 this project the investigators are addressing this lack of non-invasive diagnostic and prognostic biomarkers of EC.
Objective: the investigators aim to identify diagnostic serum metabolite and protein biomarker signatures for early detection of cancer in asymptomatic high-risk population and (secondary objective) prognostic biomarkers for selection of patients with poor prognosis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Blood samplingWomen older than 18 years and diagnosed with endometrial cancer will be included. Blood sampling will be performed on all subjects and will be used for proteomics and metabolomics analyses. |
| controls | – | Other: Blood samplingWomen older than 18 years and with a benign endometrial disturbance will be included. Blood sampling will be performed on all subjects and will be used for proteomics and metabolomics analyses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women older than 18 years and able to sign the informed consent.
Key inclusion criteria (5 listed)
- endometrioid, serous, clear cell or mucinous endometrial cancer
- dedifferentiated endometrial cancer
- high grade or low grade endometrial cancer
- benign uterine diseases, e.g. myoma uteri, prolapsed uterus
- prophylactic hysterectomy for Lynch syndrome
Key exclusion criteria (8 listed)
- atypical hyperplasia
- other types of cancer
- sarcoma uteri
- previous diagnosis of endometrial cancer
- any cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood sampling (10 mL) prior to standard care (e.g. surgery, medical treatment) | Other | Cases, controls |
Primary outcome
Creation of a diagnostic algorithm
Time frame: 2020-2021
Blood metabolome and proteome will be analysed and bioinformatics/biostatistical analysis will be used to derive diagnostic 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.
1 secondary outcome
Creation of a prognostic algorithm
Time frame: 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. To be discussed within the team, put planned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy Kruitwagen, Prof. Dr. contact
Andrea Romano principal investigator
Maastricht University Medical Centre
Tea Lanišnik Rižner, Prof. Dr. study chair
Faculty of Medicine, University of Ljubljana, Slovenia
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Andrea Romano at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands, Slovenia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Romano, Dr. (+31 433881286, a.romano@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of a diagnostic algorithm (time frame: 2020-2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.