Endometrial CancerPRSTEC_multiprNCT07368205
Preoperative Risk Stratification in Endometrial Cancer for Tailoring Lymph Node Staging
An observational study of Endometrial Cancer, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial summary
The goal of this observational study is to evaluaty the accuracy of current risk stratification of patients with endometrial cancer and to redefine lymph node staging recommendations based on real-world clinical data. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- How many people
- 350 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Feb 2026to Feb 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with histologicaly confirmed endometrial cancer.
Who may be able to join
- Women ≥18 years with newly diagnosed endometrial cancer (any histology)
- Undergoing primary surgical management
- Preoperative expert ultrasound, CT scan (could be waived in low risk cases)
- Preoperatively early-stage (stage I-II) of EC
- SLN mapping attempted intraoperatively
- FFPE tumor tissue available for molecular and IHC testing from biopsy
- Signed informed consent with the participation in the study
Who cannot join
- Neoadjuvant treatment
- Recurrent or metastatic disease at diagnosis
- Inadequate imaging or tissue samples
- Cancer synchronous duplicity
- Prior oncological treatment within the last five years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Hradec Kralove
Hradec Králové
Petra Bretova, +420777679238, bretova.petra@gmail.com
About this study
Official title: Preoperative Risk Stratification in Endometrial Cancer Using Expert Ultrasound and Molecular Classification for Tailoring Lymph Node Staging: Multicentric Prospective Observational Study
The goal of this observational study is to evaluaty the accuracy of current risk stratification of patients with endometrial cancer and to redefine lymph node staging recommendations based on real-world clinical data. The main question it aims to answer is:
Is there any group of patients who doesn't need lymph node staging for proper indication of adjuvant treatment? Participants are note taking any intervention. They are treated according to current standard of care and followed 3-years after primary surgery.
- Conditions
- Endometrial Cancer
- Being tested
- No Intervention: Observational Cohort
- Keywords
- endometrial cancer, molecular classification, expert ultrasonography, lymph node staging
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of preoperative risk stratification
Measured: From enrollment to the first follow-up visit at 4 weeks after surgery.
Determination of specific groups for whom: 1) lymph node staging is crucial for changing risk category and adjuvant treatment decisions, and 2) lymph node staging could be safely omitted
Measured: From enrollment to the first follow-up visit at 4 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start15 Feb 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368205
- Sponsor's protocol ID
- 202511P08
- Acronym
- PRSTEC_multipr
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bretova P, Ndukwe MI, Sirak I, Bizzarri N, Fruhauf F, Sukhin V, Laco J, Haviger J, Havigerova JM, Kummel J, Havelka P, Zikan M, Luptakova I, Muzykiewicz K, Novak Z, Cibula D. Pre-operative risk stratification in apparent early-stage endometrial cancer using expert ultrasound and molecular classification: a multi-center prospective observational study (PRSTEC_multipro/CEEGOG EX-07). Int J Gynecol Cancer. 2026 Jul 31:104891. doi: 10.1016/j.ijgc.2026.104891. Online ahead of print.
PubMed 42629310
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Risk Stratification in Endometrial Cancer Using Expert Ultrasound and Molecular Classification for Tailoring Lymph Node Staging: Multicentric Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07368205
- Acronym / sponsor ID
- PRSTEC_multipr / 202511P08
- Conditions
- Endometrial Cancer
- Keywords
- endometrial cancer, molecular classification, expert ultrasonography, lymph node staging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 26 Jan 2026 (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.
The goal of this observational study is to evaluaty the accuracy of current risk stratification of patients with endometrial cancer and to redefine lymph node staging recommendations based on real-world clinical data. The main question it aims to answer is:
Is there any group of patients who doesn't need lymph node staging for proper indication of adjuvant treatment? Participants are note taking any intervention. They are treated according to current standard of care and followed 3-years after primary surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologicaly confirmed endometrial cancer.
Key inclusion criteria (7 listed)
- Women ≥18 years with newly diagnosed endometrial cancer (any histology)
- Undergoing primary surgical management
- Preoperative expert ultrasound, CT scan (could be waived in low risk cases)
- Preoperatively early-stage (stage I-II) of EC
- SLN mapping attempted intraoperatively
Key exclusion criteria (5 listed)
- Neoadjuvant treatment
- Recurrent or metastatic disease at diagnosis
- Inadequate imaging or tissue samples
- Cancer synchronous duplicity
- Prior oncological treatment within the last five years
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 |
|---|---|---|
| No Intervention: Observational CohortNo intervention | Other | – |
Primary outcome
The accuracy of preoperative risk stratification
Time frame: From enrollment to the first follow-up visit at 4 weeks after surgery.
Determination of specific groups for whom: 1) lymph node staging is crucial for changing risk category and adjuvant treatment decisions, and 2) lymph node staging could be safely omitted
Time frame: From enrollment to the first follow-up visit at 4 weeks after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 42629310Bretova P, Ndukwe MI, Sirak I, Bizzarri N, Fruhauf F, Sukhin V, Laco J, Haviger J, Havigerova JM, Kummel J, Havelka P, Zikan M, Luptakova I, Muzykiewicz K, Novak Z, Cibula D. Pre-operative risk stratification in apparent early-stage endometrial cancer using expert ultrasound and molecular classification: a multi-center prospective observational study (PRSTEC_multipro/CEEGOG EX-07). Int J Gynecol Cancer. 2026 Jul 31:104891. doi: 10.1016/j.ijgc.2026.104891. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by University Hospital Hradec Kralove at 1 site in Czechia.
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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of preoperative risk stratification (time frame: From enrollment to the first follow-up visit at 4 weeks after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07368205, which also lists 1 linked publication.
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 22 May 2026.