MRI Radiomics Combined With Pathomics on the Prediction of Molecular Classification and Prognosis of Endometrial Cancer

NCT ID: NCT06126393

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2027-06-30

Brief Summary

Molecular typing provides accurate information for the diagnosis, treatment and prognosis prediction of endometrial cancer, which has important clinical significance. However, due to its high cost and complicated process, it is difficult to be widely used in clinical practice. Based on the artificial intelligence method, this study fused the characteristics of MRI radiomics and pathomics, combined with the clinical pathological information, built a model to predict the molecular typing and prognosis, analyzed the biological characteristics of endometrial cancer from the multi-scale level, guided the personalized and precise diagnosis and treatment, in order to improve the prognosis of patients.

Detailed Description

In this project, 150 cases of endometrial cancer were retrospectively collected, and 200 cases of endometrial cancer will be prospectively collected. All patients were pathologically confirmed and underwent Promise molecular typing. Before treatment, all patients completed abdominal MRI. Based on artificial intelligence technology, image features were extracted from magnetic resonance imaging, pathological features were extracted from pathological data, and clinical pathological data were collected at the same time. The treatment effect, recurrence and metastasis of patients were followed up, and the five-year survival rate and five-year progression free survival rate were calculated. It is proposed to focus on the following research:

1. Construction of molecular typing and prognosis prediction model of endometrial cancer based on magnetic resonance imaging Radiomics

2. Construction of molecular typing and prognosis prediction model of endometrial cancer based on pathomics.

3. Construction of a prediction model for molecular typing of endometrial cancer by integrating pathomics and radiomics.

Conditions

Endometrial Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

POLE Mut

The POLE gene mutation detection was performed, and the mutation Changes were classified as POLE mutation.

next generation sequencing AND Immunohistochemical examination

Intervention Type: DIAGNOSTIC_TEST

First, the mismatch repair (MMR) proteins were detected by immunohistochemistry, and the deletion of one or more proteins was classified as d-MMR subtype; Then the POLE gene mutation detection was performed, and the mutation Changes were classified as POLE mutation; Finally, p53 was detected by immunohistochemistry, and p53 mutant (p53 abn) and p53 wild-type (p53wt) were distinguished.

dMMR

The mismatch repair (MMR) proteins were detected by immunohistochemistry, and the deletion of one or more proteins was classified as d-MMR subtype

next generation sequencing AND Immunohistochemical examination

Intervention Type: DIAGNOSTIC_TEST

First, the mismatch repair (MMR) proteins were detected by immunohistochemistry, and the deletion of one or more proteins was classified as d-MMR subtype; Then the POLE gene mutation detection was performed, and the mutation Changes were classified as POLE mutation; Finally, p53 was detected by immunohistochemistry, and p53 mutant (p53 abn) and p53 wild-type (p53wt) were distinguished.

P53abn

The expression of p53 was detected by immunohistochemistry. The abnormality of p53 protein expression (completely negative or diffusely strong positive in the nucleus) or expression location (cytoplasmic expression) was judged as p53abn, otherwise it was p53wt.

next generation sequencing AND Immunohistochemical examination

Intervention Type: DIAGNOSTIC_TEST

First, the mismatch repair (MMR) proteins were detected by immunohistochemistry, and the deletion of one or more proteins was classified as d-MMR subtype; Then the POLE gene mutation detection was performed, and the mutation Changes were classified as POLE mutation; Finally, p53 was detected by immunohistochemistry, and p53 mutant (p53 abn) and p53 wild-type (p53wt) were distinguished.

P53wt

The expression of p53 was detected by immunohistochemistry. The abnormality of p53 protein expression (completely negative or diffusely strong positive in the nucleus) or expression location (cytoplasmic expression) was judged as p53abn, otherwise it was p53wt.

next generation sequencing AND Immunohistochemical examination

Intervention Type: DIAGNOSTIC_TEST

First, the mismatch repair (MMR) proteins were detected by immunohistochemistry, and the deletion of one or more proteins was classified as d-MMR subtype; Then the POLE gene mutation detection was performed, and the mutation Changes were classified as POLE mutation; Finally, p53 was detected by immunohistochemistry, and p53 mutant (p53 abn) and p53 wild-type (p53wt) were distinguished.

Interventions

next generation sequencing AND Immunohistochemical examination

First, the mismatch repair (MMR) proteins were detected by immunohistochemistry, and the deletion of one or more proteins was classified as d-MMR subtype; Then the POLE gene mutation detection was performed, and the mutation Changes were classified as POLE mutation; Finally, p53 was detected by immunohistochemistry, and p53 mutant (p53 abn) and p53 wild-type (p53wt) were distinguished.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Magnetic resonance examination

Eligibility Criteria

Inclusion Criteria

• •Pathologically confirmed as endometrial malignant tumor with complete pathological H＆E stained sections;

• Age ≥ 18 years and ≤ 80 years;
• No other malignant cancers was found;
• The complete immunohistochemical and second-generation sequencing results can be used for the molecular typing of ProMisE;
• Magnetic resonance examination was performed within 2 weeks before treatment, and there was at least one measurable lesion according to RECIST 1.1 Criteria.

Exclusion Criteria

• • The image quality is poor or the tumor is too small due to serious graphic artifact and degeneration, and the ROI cannot be accurately delineated;

• Patients who received any antitumor therapy before surgery;
• Diagnostic endometrial biopsy before MRI

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fujian Provincial Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role: collaborator

Gutian Hospital

UNKNOWN

Sponsor Role: collaborator

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital

Fuzhou, Fujian, China

Countries

China

Central Contacts

Jian Chen, Master

Role: CONTACT

marsz3@126.com

15806030009

Facility Contacts

Jian Chen, Master

Role: primary

marsz3@126.com

15806030009

References

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Reference Type: RESULT

PMID: 36656410 (View on PubMed)

Jamieson A, McAlpine JN. Molecular Profiling of Endometrial Cancer From TCGA to Clinical Practice. J Natl Compr Canc Netw. 2023 Feb;21(2):210-216. doi: 10.6004/jnccn.2022.7096.

Reference Type: RESULT

PMID: 36791751 (View on PubMed)

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Reference Type: RESULT

PMID: 32974143 (View on PubMed)

Lefebvre TL, Ueno Y, Dohan A, Chatterjee A, Vallieres M, Winter-Reinhold E, Saif S, Levesque IR, Zeng XZ, Forghani R, Seuntjens J, Soyer P, Savadjiev P, Reinhold C. Development and Validation of Multiparametric MRI-based Radiomics Models for Preoperative Risk Stratification of Endometrial Cancer. Radiology. 2022 Nov;305(2):375-386. doi: 10.1148/radiol.212873. Epub 2022 Jul 12.

Reference Type: RESULT

PMID: 35819326 (View on PubMed)

Crosbie EJ, Kitson SJ, McAlpine JN, Mukhopadhyay A, Powell ME, Singh N. Endometrial cancer. Lancet. 2022 Apr 9;399(10333):1412-1428. doi: 10.1016/S0140-6736(22)00323-3.

Reference Type: RESULT

PMID: 35397864 (View on PubMed)

Other Identifiers

CHENJIAN1

Identifier Type: -

Identifier Source: org_study_id