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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010487
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Lei Li, Peking Union Medical College Hospital

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

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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

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




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.


Information from the National Library of Medicine

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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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010487


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
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Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04010487    
Other Study ID Numbers: AM-OMICS2
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Adenomyosis
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases