NCT03553589

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
3 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 12, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

December 5, 2018

Status Verified

December 1, 2018

Enrollment Period

2.7 years

First QC Date

May 30, 2018

Last Update Submit

December 3, 2018

Conditions

Endometrial Cancer

Keywords

metabolomicsproteomicsearly diagnosisprognosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    2020-2021

Secondary Outcomes (1)

  • Creation of a prognostic algorithm

    2021

Study Arms (2)

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

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

Interventions

Blood samplingOTHER

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

Casescontrols

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Maastricht University Medical Centre

Maastricht, Netherlands

RECRUITING

Maxima Medical Centre

Veldhoven, Netherlands

NOT YET RECRUITING

Lublin Medical University

Lublin, Poland

RECRUITING

Faculty of Medicine, University of Ljubljana

Ljubljana, Slovenia

NOT YET RECRUITING

University Medical Centre, Ljubljana

Ljubljana, Slovenia

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples

MeSH Terms

Conditions

Endometrial NeoplasmsDisease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Andrea Romano

    Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

  • Tea Lanišnik Rižner, Prof. Dr.

    Faculty of Medicine, University of Ljubljana, Slovenia

    STUDY CHAIR

Central Study Contacts

Andrea Romano, Dr.

CONTACT

+31 433881286a.romano@maastrichtuniversity.nl

Roy Kruitwagen, Prof. Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD. Assistant Professor

Study Record Dates

First Submitted

May 30, 2018

First Posted

June 12, 2018

Study Start

October 1, 2018

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

December 5, 2018

Record last verified: 2018-12

Locations

NL(2)PL(1)SL(2)