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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04010487
• Other study ID #: AM-OMICS2
• Status: Recruiting
• Start date: July 16, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: July 2019
• Source: Peking Union Medical College Hospital
• Contact: Lei Li, M.D.
• Phone: +8613911988831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Adenomyosis
• Ectopic Endometrial Tissue
• Endometrial Cancer
• Endometrial Neoplasms
• Eutopic Endometrium
• Genomics
• Transcriptomics

Intervention

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

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequencies of somatic driving mutations	The differences of distributions and frequencies of somatic driving mutations will be compared between eutopic ectopic endometrium, and cancer tissues by whole exome sequencing	One year
Primary	Frequencies of alteration of RNA expression	The alteration of RNA expression, including mRNA, miRNA, and lncRNA will be compared between eutopic and ectopic endometrium, and cancer tissues by transcriptome sequencing	One year