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出境医 / 临床实验 / Multi-omics Study on the Pathogenesis of Malignant Transformation of Adenomyosis

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

Study Description
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).

Condition or disease Intervention/treatment
Adenomyosis Endometrial Cancer Ectopic Endometrial Tissue Eutopic Endometrium Genomics Transcriptomics Genetic: whole exome sequencing and RNA-sequencing

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: A Multi-omics Study on the Pathogenesis of Malignant Transformation of Adenomyosis
Actual Study Start Date : July 16, 2019
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
Endometrial carcinoma arising in adenomyosis
Patients pathologically conformed endometrial carcinoma arising in adenomyosis (EC-AIA)
 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
Adenomyosis without malignancy
Patients pathologically diagnosed with adenomyosis
 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
Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   Samples With DNA
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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study population includes two groups patients (about 22 cases in each group):

  • Patients pathologically conformed endometrial carcinoma arising in adenomyosis (EC-AIA)
  • Patients pathologically diagnosed with adenomyosis
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.)
Contacts and Locations

Contacts
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Contact: Lei Li, M.D. +8613911988831 lileigh@163.com

Locations
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China, Beijing
Lei Li Recruiting
Beijing, Beijing, China, 100730
Contact: Lei Li, MD    008613911988831    lileigh@163.com   
Sponsors and Collaborators
Lei Li
Investigators
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Principal Investigator: Lei Li, M.D. Peking Union Medical College Hospital
Tracking Information
First Submitted Date July 3, 2019
First Posted Date July 8, 2019
Last Update Posted Date July 18, 2019
Actual Study Start Date July 16, 2019
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 3, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
Sampling Method Non-Probability Sample
Study Population

Study population includes two groups patients (about 22 cases in each group):

  • Patients pathologically conformed endometrial carcinoma arising in adenomyosis (EC-AIA)
  • Patients pathologically diagnosed with adenomyosis
Condition
  • Adenomyosis
  • Endometrial Cancer
  • Ectopic Endometrial Tissue
  • 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
Study Groups/Cohorts
  • Endometrial carcinoma arising in adenomyosis
    Patients pathologically conformed endometrial carcinoma arising in adenomyosis (EC-AIA)
    Intervention: Genetic: whole exome sequencing and RNA-sequencing
  • Adenomyosis without malignancy
    Patients pathologically diagnosed with adenomyosis
    Intervention: Genetic: whole exome sequencing and RNA-sequencing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 3, 2019) 		40
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 1, 2021
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
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.)
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Lei Li, M.D. +8613911988831 lileigh@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04010487
Other Study ID Numbers AM-OMICS2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Lei Li, Peking Union Medical College Hospital
Study Sponsor Lei Li
Collaborators Not Provided
Investigators
Principal Investigator: Lei Li, M.D. Peking Union Medical College Hospital
PRS Account Peking Union Medical College Hospital
Verification Date July 2019

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