Multi-omics Study on the Pathogenesis of Malignant Transformation of Adenomyosis

Overview

This study is to explore the driving genes and the molecular mechanism of malignant transformation of adenomyosis. This study acquired the formalin fixed paraffin-embedded (FFPE) tissue of patients pathologically conformed endometrial carcinoma arising in adenomyosis (EC-AIA) treated at Peking Union Medical College Hospital from July 15, 2017 to July 15, 2019. The formalin fixed paraffin-embedded tissues from patients pathologically diagnosed with adenomyosis during this time period were also included as control specimens. The eutopic endometrium, normal adenomyosis tissue, and EC-AIA tissue were harvested from the FFPE tissue from patients with EC-AIA. The normal eutopic endometrium and normal adenomyosis tissue were obtained by laser microdissection. The driving genes and potential molecular mechanism of EC-AIA will be found by the technology of whole exome sequencing and transcriptomics (RNA-sequencing).

Full Title of Study: “A Multi-omics Study on the Pathogenesis of Malignant Transformation of Adenomyosis”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 1, 2021

Interventions

  • Genetic: whole exome sequencing and RNA-sequencing
    • The specimens from adenomyosis, endometrial cancer, and eutopic endometrium will be tested by whole exome sequencing and RNA-sequencing

Arms, Groups and Cohorts

  • Endometrial carcinoma arising in adenomyosis
    • Patients pathologically conformed endometrial carcinoma arising in adenomyosis (EC-AIA)
  • Adenomyosis without malignancy
    • Patients pathologically diagnosed with adenomyosis

Clinical Trial Outcome Measures

Primary Measures

  • Frequencies of somatic driving mutations
    • Time Frame: One year
    • The differences of distributions and frequencies of somatic driving mutations will be compared between eutopic ectopic endometrium, and cancer tissues by whole exome sequencing
  • Frequencies of alteration of RNA expression
    • Time Frame: One year
    • The alteration of RNA expression, including mRNA, miRNA, and lncRNA will be compared between eutopic and ectopic endometrium, and cancer tissues by transcriptome sequencing

Participating in This Clinical Trial

Inclusion Criteria

  • Pathological confirmed diagnosis with atypical hyperplasia and malignant transformation of adenomyosis glandular epithelium (including endometrioid, serous and clear cell carcinoma), with or without concurrent endometrial carcinoma – Signed an approved informed consents Exclusion Criteria:

  • Not meeting all the inclusion criteria. – The formalin fixed paraffin-embedded (FFPE) tissue was not acquired at the required time period. – The patients enrolled had accompanied some other kinds of carcinoma (such as ovarian cancer, cervical cancer, primary peritoneal cancer). – Patients had cancer history of certain organ (such as colorectal cancer, gastric cancer, etc.)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lei Li
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Lei Li, Professor – Peking Union Medical College Hospital
  • Overall Official(s)
    • Lei Li, M.D., Principal Investigator, Peking Union Medical College Hospital
  • Overall Contact(s)
    • Lei Li, M.D., +8613911988831, lileigh@163.com

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