Biomarkers for Diagnosis and Prognosis of Endometrial Carcinoma (BioEndoCar)

December 3, 2018 updated by: Andrea Romano

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Roy Kruitwagen, Prof. Dr.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Recruiting
        • Maastricht University Medical Centre
        • Contact:
        • Sub-Investigator:
          • Roy Kruitwagen, Prof. dr.
      • Veldhoven, Netherlands
        • Not yet recruiting
        • Maxima Medical Centre
        • Contact:
          • Marlies Bongers, Prof. dr.
  • Poland
      • Lublin, Poland
        • Recruiting
        • Lublin Medical University
        • Contact:
  • Slovenia
      • Ljubljana, Slovenia
        • Not yet recruiting
        • Faculty of Medicine, University of Ljubljana
        • Contact:
      • Ljubljana, Slovenia
        • Recruiting
        • University Medical Centre, Ljubljana
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women older than 18 years and able to sign the informed consent.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2020-2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrea Romano

Collaborators

Medical University of Lublin
University of Ljubljana, Faculty of Medicine

Investigators

  • Principal Investigator: Andrea Romano, Maastricht University Medical Centre
  • Study Chair: Tea Lanišnik Rižner, Prof. Dr., Faculty of Medicine, University of Ljubljana, Slovenia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

May 30, 2018

First Submitted That Met QC Criteria

May 30, 2018

First Posted (Actual)

June 12, 2018

Study Record Updates

Last Update Posted (Actual)

December 5, 2018

Last Update Submitted That Met QC Criteria

December 3, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL63773

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

To be discussed within the team, put planned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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