Prevalence of somatic and germline mutations in patients with Primary or relapsed endometrial carcinomas

Prevalence of somatic and germline mutations in patients with Primary or relapsed endometrial carcinomas - AGO-TR 2

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030300

Enrollment

400

Registered

2022-11-03

Start date

2023-03-29

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C54.1

Interventions

Group 1: 200 patients with advanced stage (> T1 and/or N+) or recurrent carcinoma will be included. The aim of this prospective translational study is to investigate the prevalence of different germl

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Signed written informed consent. 2. Patients = 18 years with primary or any relapsed endometrial carcinomas (all subtypes), diagnosed or treated within the last 6 months. 3. Available tumor samples (tumor tissue sample of primary diagnosis and/or relapsed disease if available). For early stage disease 1st priority sample: tumor from hysterectomy specimen. If not sufficient tumor load is present 2nd priority sample: tumor from dilation and curettage (D&C). For relapsed patients, tumor sample from time of relapse would be preferred.

Exclusion criteria

Exclusion criteria: 1. Non-invasive carcinomas or precancerous lesions. (History of prior malignancy is allowed). 2. No available tumor sample 3. Missing informed consent 4. Any medical condition preventing informed consent 5. Failure to consent to registration, not willing to storageallow storage or handling of personal information, blood or tumor samples, or not willing to participate in assessment of family history.

Design outcomes

Primary

Measure	Time frame
• Detection of genetic germline and somatic mutations in patients with endometrial cancers	—

Secondary

Measure	Time frame
• DNA and IHC-analysis to classify into tumor subgroups (p53, POLE, MMR, Copy number high and low) • Correlation of genetic germline and somatic mutations, cancer treatment, progression free and overall survival and development of secondary malignancies • Evaluation of quality of life using validated questionnaires (EORTC QLQ-30 and its module EN24) • Family history of hereditary cancer syndromes using tools for BRCA and HNPCC • Evaluation of PD1 /PDL1 tumor expression • Estimation of the frequency and prognostic relevance of L1-CAM and HER2 expression in all patients and patients with serous histology, respectively • Quantification of MLH1 promotor methylation • Detection of HRD phenotype • Description of genetic differences between primary and relapsed tumor samples	—

Measure

Time frame

• DNA and IHC-analysis to classify into tumor subgroups (p53, POLE, MMR, Copy number high and low) • Correlation of genetic germline and somatic mutations, cancer treatment, progression free and overall survival and development of secondary malignancies • Evaluation of quality of life using validated questionnaires (EORTC QLQ-30 and its module EN24) • Family history of hereditary cancer syndromes using tools for BRCA and HNPCC • Evaluation of PD1 /PDL1 tumor expression • Estimation of the frequency and prognostic relevance of L1-CAM and HER2 expression in all patients and patients with serous histology, respectively • Quantification of MLH1 promotor methylation • Detection of HRD phenotype • Description of genetic differences between primary and relapsed tumor samples

—

Countries

Germany

Contacts

Public ContactYvonne Treffner

AGO Research GmbH

ytreffner@ago-ovar.de0201 95 98 12 0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026