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Biomarkers for Diagnosis and Prognosis of Endometrial Carcinoma (BioEndoCar)

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ClinicalTrials.gov Identifier: NCT03553589
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborators:
University of Ljubljana, Faculty of Medicine
Medical University of Lublin
Information provided by (Responsible Party):
Andrea Romano, Academisch Ziekenhuis Maastricht

Brief 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.

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.


Condition or disease Intervention/treatment
Endometrial Cancer Other: Blood sampling

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.


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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Minimally and Non-invasive Methods for Early Detection and Progression of Endometrial Cancer
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Group/Cohort Intervention/treatment
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.
Other: Blood sampling
Blood sampling (10 mL) prior to standard care (e.g. surgery, medical treatment)

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.
Other: Blood sampling
Blood sampling (10 mL) prior to standard care (e.g. surgery, medical treatment)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Creation of a prognostic algorithm [ Time Frame: 2021 ]
    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.


Biospecimen Retention:   Samples Without DNA
serum samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women older than 18 years and able to sign the informed consent.
Criteria

Inclusion Criteria Cases:

  • endometrioid, serous, clear cell or mucinous endometrial cancer
  • dedifferentiated endometrial cancer
  • high grade or low grade endometrial cancer

Inclusion Criteria Controls:

  • benign uterine diseases, e.g. myoma uteri, prolapsed uterus
  • prophylactic hysterectomy for Lynch syndrome

Exclusion Criteria Cases:

  • atypical hyperplasia
  • other types of cancer
  • sarcoma uteri
  • previous diagnosis of endometrial cancer

Exclusion Criteria Controls:

  • any cancer
  • benign ovarian diseases
  • previous EC
  • pregnancy at the time of enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553589


Contacts
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Contact: Andrea Romano, Dr. +31 433881286 a.romano@maastrichtuniversity.nl
Contact: Roy Kruitwagen, Prof. Dr.

Locations
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Netherlands
Maastricht University Medical Centre Recruiting
Maastricht, Netherlands
Contact: Andrea Romano, dr.    +31 43 3881286    a.romano@maastrichtuniversity.nl   
Sub-Investigator: Roy Kruitwagen, Prof. dr.         
Maxima Medical Centre Not yet recruiting
Veldhoven, Netherlands
Contact: Marlies Bongers, Prof. dr.         
Poland
Lublin Medical University Recruiting
Lublin, Poland
Contact: Andrzej Semczuk, Prof    +48 81 7244262    andrzej.semczuk@umlub.pl   
Slovenia
Faculty of Medicine, University of Ljubljana Not yet recruiting
Ljubljana, Slovenia
Contact: Tea Lanišnik Rižner, Prof. dr.    +386 1543 7657    tea.lanisnik-rizner@mf.uni-lj.si   
University Medical Centre, Ljubljana Recruiting
Ljubljana, Slovenia
Contact: Špela Smrkolj, Prof. Dr.       spela.smrkolj@kclj.si   
Sponsors and Collaborators
Andrea Romano
University of Ljubljana, Faculty of Medicine
Medical University of Lublin
Investigators
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Principal Investigator: Andrea Romano Maastricht University Medical Centre
Study Chair: Tea Lanišnik Rižner, Prof. Dr. Faculty of Medicine, University of Ljubljana, Slovenia

Additional Information:
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Responsible Party: Andrea Romano, PhD. Assistant Professor, Academisch Ziekenhuis Maastricht
ClinicalTrials.gov Identifier: NCT03553589     History of Changes
Other Study ID Numbers: NL63773
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be discussed within the team, put planned

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrea Romano, Academisch Ziekenhuis Maastricht:
metabolomics
proteomics
early diagnosis
prognosis
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female