Brief Title
Multi-omics Study on the Pathogenesis of Malignant Transformation of Adenomyosis
Official Title
A Multi-omics Study on the Pathogenesis of Malignant Transformation of Adenomyosis
Brief 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).
Study Type
Observational
Primary Outcome
Frequencies of somatic driving mutations
Condition
Adenomyosis
Intervention
whole exome sequencing and RNA-sequencing
Study Arms / Comparison Groups
Endometrial carcinoma arising in adenomyosis
Description: Patients pathologically conformed endometrial carcinoma arising in adenomyosis (EC-AIA)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Genetic
Estimated Enrollment
40
Start Date
July 16, 2019
Completion Date
August 1, 2021
Primary Completion Date
August 1, 2021
Eligibility Criteria
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
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Lei Li, M.D., +8613911988831, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04010487
Organization ID
AM-OMICS2
Responsible Party
Sponsor-Investigator
Study Sponsor
Lei Li
Study Sponsor
Lei Li, M.D., Principal Investigator, Peking Union Medical College Hospital
Verification Date
July 2019