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

NCT ID: NCT04010487

Last Updated: 2019-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-16

Study Completion Date

2021-08-01

Brief Summary

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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).

Detailed Description

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Conditions

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Adenomyosis Endometrial Cancer Ectopic Endometrial Tissue Eutopic Endometrium Genomics Transcriptomics

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Endometrial carcinoma arising in adenomyosis

Patients pathologically conformed endometrial carcinoma arising in adenomyosis (EC-AIA)

whole exome sequencing and RNA-sequencing

Intervention Type GENETIC

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

Adenomyosis without malignancy

Patients pathologically diagnosed with adenomyosis

whole exome sequencing and RNA-sequencing

Intervention Type GENETIC

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

Interventions

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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

Intervention Type GENETIC

Eligibility Criteria

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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

* 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.)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lei Li

OTHER

Sponsor Role lead

Responsible Party

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Lei Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lei Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Lei Li

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Li, M.D.

Role: CONTACT

+8613911988831

Facility Contacts

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Lei Li, MD

Role: primary

008613911988831

Other Identifiers

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AM-OMICS2

Identifier Type: -

Identifier Source: org_study_id

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