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Endometrial Cancer, Endometrial NeoplasmNCT07006103

Precision Medicine Applied to the Study of Endometrial Cancer: Application of NGS for Molecular Classification

An observational study of Endometrial Cancer, Endometrial Neoplasm, run by Hospital Italiano de Buenos Aires.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

In recent years, knowledge about cancer biology has expanded significantly. The study of gene expression profiles has revealed the heterogeneous nature and potential reclassification of the various tumor subtypes based on specific genetic alterations. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer, Endometrial Neoplasm
How many people
400 participants
Where
No sites listed yet
Study dates
Jun 2025to Dec 2026
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 of Hospital Italiano de Buenos Aires. Section of Pathological Anatomy, Sequencing and Gynecological Oncology, and the "Norberto Quirno" Center for Medical Education and Clinical Research (CEMIC). Service of Pathological Anatomy, Molecular Pathology, Gynecology, Institute of Oncology, and Institute of Precision Medicine.

Who may be able to join

  • Patients over 18 years of age with a diagnosis of EC diagnosed by histological biopsy and surgically treated sequentially in the participating centers in the last 5 years with clinical follow-up.
  • Patients over 18 years of age, diagnosed with CE III-IV by histological biopsy, not susceptible to surgical treatment in each institution during the last 5 years in clinical follow-up. Cases with a diagnosis of carcinosarcoma (a rare subtype of endometrial carcinoma with sarcomatous transdifferentiation) are included.
  • Material blocks fixed in formalin and embedded in paraffin with a tumor volume in the paraffin block of at least 1 cm3

Who cannot join

  • The following uterine neoplasms will be excluded:
  • Biphasic tumors (epithelial-mesenchymal) such as adenosarcoma.
  • Mesenchymal neoplasms such as endometrial stromal sarcoma and leiomyosarcomas.
  • Others: primary lymphoproliferative processes of the uterine body; neuroendocrine tumors; Gestational trophoblastic disease, secondary lesions either of the genital tract (example: cervical carcinomas with extension to the endometrium) or of distant sites (breast cancer metastasis).
  • Patients with synchronous endometrial and ovarian carcinoma
  • For technical reasons, they will be excluded
Show all 12Show fewer
  • tumors smaller than 0.2 cm in which sufficient material cannot be obtained for immunohistochemical and molecular biology determinations.
  • Tumors with severe artifacts due to poor processing, such as autolysis.
  • Samples with low-quality DNA
  • Patients operated on outside participating centers.
  • Patients under 18 years of age.
  • Patients with primary non-surgical treatments (neoadjuvant chemotherapy).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Hernan García Rivello MD, PhD contact

+54 11 4959 0200 ext. 9210

hernan.garciarivello@hospitalitaliano.org.ar

Romina Albite D Bsc, Phd contact

+54 11 4959 0200 ext. 5168

romina.albite@hospitalitaliano.org.ar

About this study

Official title: Precision Medicine Applied to Endometrial Cancer (EC)

In recent years, knowledge about cancer biology has expanded significantly. The study of gene expression profiles has revealed the heterogeneous nature and potential reclassification of the various tumor subtypes based on specific genetic alterations. This is of great importance since it allows a therapeutic approach more directed to the intrinsic characteristics of each tumor (precision medicine).

Integrating clinicopathological information with molecular classification could provide new guidelines when approaching patients with EC, both in preoperative assessment and in adjuvant treatment and surveillance.

Read more

The application of molecular classification in endometrial carcinomas shows a subgroup of patients with an excellent prognosis, corresponding to the POLEmut subgroup that could be reclassified with eventual therapeutic de-escalation.

The clinical guidelines for the management of patients with endometrial cancer proposed by ESGO/ESTRO/ESP in 2020 recommend the use of this new classification, and warn that clinical management may be modified by the molecular classification in scenarios where adjuvant chemotherapy is considered (high-grade/high-risk disease).

Keywords
endometrial cancer, molecular classification, POLEmut subgroup
Medical subject headings
Endometrial Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distribution of Endometrial Cancer Molecular Subtypes Identified by Immunohistochemistry and POLE Sequencing

    Proportion of patients in each of the four molecular subtypes of endometrial cancer (POLE-ultramutated, microsatellite instability hypermutated, copy-number low, copy-number high) determined using immunohistochemistry for MMR proteins and TP53, and NGS-based sequencing of the POLE gene.

    Measured: At study inclusion (retrospective evaluation of cases from the last 5 years). Units: Percentage of patients per subtype

Secondary outcomes (2)

  1. Association Between Molecular Subtypes and Histological Risk Categories.

    Proportion of patients with low- versus high-risk histological types within each molecular subtype.

    Measured: At study inclusion (retrospective evaluation of cases from the last 5 years).

  2. Time to Recurrence by Molecular Subtype

    Time (in months) from diagnosis to first documented relapse, stratified by molecular subtype.

    Measured: At study inclusion (retrospective evaluation of cases from the last 5 years).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionJul 2025 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Retrospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07006103
Sponsor's protocol ID
6760
Status last verified
Jun 2025
First submitted
16 May 2025
Last updated
8 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Stelloo E, Nout RA, Osse EM, Jurgenliemk-Schulz IJ, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Nijman HW, Putter H, Bosse T, Creutzberg CL, Smit VT. Improved Risk Assessment by Integrating Molecular and Clinicopathological Factors in Early-stage Endometrial Cancer-Combined Analysis of the PORTEC Cohorts. Clin Cancer Res. 2016 Aug 15;22(16):4215-24. doi: 10.1158/1078-0432.CCR-15-2878. Epub 2016 Mar 22.

    PubMed 27006490

  • Talhouk A, McConechy MK, Leung S, Yang W, Lum A, Senz J, Boyd N, Pike J, Anglesio M, Kwon JS, Karnezis AN, Huntsman DG, Gilks CB, McAlpine JN. Confirmation of ProMisE: A simple, genomics-based clinical classifier for endometrial cancer. Cancer. 2017 Mar 1;123(5):802-813. doi: 10.1002/cncr.30496. Epub 2017 Jan 6.

    PubMed 28061006

  • Hoang LN, Kinloch MA, Leo JM, Grondin K, Lee CH, Ewanowich C, Kobel M, Cheng A, Talhouk A, McConechy M, Huntsman DG, McAlpine JN, Soslow RA, Gilks CB. Interobserver Agreement in Endometrial Carcinoma Histotype Diagnosis Varies Depending on The Cancer Genome Atlas (TCGA)-based Molecular Subgroup. Am J Surg Pathol. 2017 Feb;41(2):245-252. doi: 10.1097/PAS.0000000000000764.

    PubMed 28079598

  • Kobel M, Nelson GS. Letter in response to: McAlpine J, Leon-Castillo A, Bosse T. The rise of a novel classification system for endometrial carcinoma; integration of molecular subclasses. J Pathol 2018; 244: 538-549. J Pathol. 2018 Jun;245(2):249-250. doi: 10.1002/path.5068. Epub 2018 Apr 16. No abstract available.

    PubMed 29512840

  • Cancer Genome Atlas Research Network; Kandoth C, Schultz N, Cherniack AD, Akbani R, Liu Y, Shen H, Robertson AG, Pashtan I, Shen R, Benz CC, Yau C, Laird PW, Ding L, Zhang W, Mills GB, Kucherlapati R, Mardis ER, Levine DA. Integrated genomic characterization of endometrial carcinoma. Nature. 2013 May 2;497(7447):67-73. doi: 10.1038/nature12113.

    PubMed 23636398

  • Bendifallah S, Canlorbe G, Collinet P, Arsene E, Huguet F, Coutant C, Hudry D, Graesslin O, Raimond E, Touboul C, Darai E, Ballester M. Just how accurate are the major risk stratification systems for early-stage endometrial cancer? Br J Cancer. 2015 Mar 3;112(5):793-801. doi: 10.1038/bjc.2015.35. Epub 2015 Feb 12.

    PubMed 25675149

  • Imai K, Kato H, Katayama K, Nakanishi K, Kawano A, Iura A, Konnai K, Onose R, Hirahara F, Miyagi E. A preoperative risk-scoring system to predict lymph node metastasis in endometrial cancer and stratify patients for lymphadenectomy. Gynecol Oncol. 2016 Aug;142(2):273-7. doi: 10.1016/j.ygyno.2016.06.004. Epub 2016 Jun 15.

    PubMed 27268220

  • Bokhman JV. Two pathogenetic types of endometrial carcinoma. Gynecol Oncol. 1983 Feb;15(1):10-7. doi: 10.1016/0090-8258(83)90111-7.

    PubMed 6822361

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

Questions about this trial

What is this clinical trial studying?

An observational study of Endometrial Cancer, Endometrial Neoplasm, run by Hospital Italiano de Buenos Aires.

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 3 inclusion and 12 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: opening soon, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Hernan García Rivello MD, PhD (+54 11 4959 0200 ext. 9210, hernan.garciarivello@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distribution of Endometrial Cancer Molecular Subtypes Identified by Immunohistochemistry and POLE Sequencing (time frame: At study inclusion (retrospective evaluation of cases from the last 5 years). Units: Percentage of patients per subtype). 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 NCT07006103, which also lists 9 linked publications.

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 8 Jun 2025.

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