- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04137406
Role of SIRT1 in Regulation of Epithelial-to-mesenchymal Transition in Breast Cancer Lymph Nodes Metastasis
October 22, 2019 updated by: Peking University People's Hospital
Role of SIRT1 in Regulation of Epithelial-to-mesenchymal Transition in Breast Cancer Lymph Nodes Metastasis for Luminal A Subtype
Luminal A breast cancer is a kind of breast cancer with low rate lymph node metastasis and good survival.
But in clinical practice, Luminal A breast cancer can present with early, unexpected lymph node metastasis some time, indicates poor survival.
Silent information regulator 2 homolog 1 (SIRT1) plays a different role in breast cancer with different molecular typing.
Previous study supports a role of SIRT1 protein as tumor suppressor in Luminal A breast cancer, in association with apoptosis-related proteins.
The epithelial-to-mesenchymal transition(EMT) process results in loss of cell-cell adhesion, increased cell mobility, and is crucial for enabling the metastasis of cancer cells.
But no similar study in Luminal A breast cancer.
Hence, this study will 1) investigate the expression pattern of SIRT1 in primary tumor and lymph node metastasis; 2) investigate the different expression pattern of SIRT1 in T2/T3 , lymph node negative tumor and T1, lymph node positive tumor; 3) investigate potential role of SIRT1 enzyme in regulating cell migration and invasion in Luminal A breast cancer cells.
Study Overview
Status
Unknown
Conditions
Detailed Description
The study has three parts.
- In large specimens of human Luminal A breast cancer with T1 tumor and positive axillary lymph node, study the difference expression of SIRT1 and related p53, Bcl-2, autophagy-related protein caspase-3, apaf-1 between primary tumor and lymph node metastases. Collect 50 pairs of T1 primary tumors and corresponding metastatic lymph node specimens. Using immunohistochemistry, anti-SIRT1, p53, Bcl-2, caspase-3 and apaf-1 antibody staining to identify the expression of above proteins in the primary tumor and lymph node metastases.
- Eighty patients with Luminal type A breast cancer (T1N+) were enrolled in this study. At the same time,eighty patients were enrolled in the paraffin-embedded specimens of the patients with T2N+ and T3N+,too. And all patients were followed up. Immunohistochemical staining with anti-SIRT1, p53, Bcl-2, caspase-3, apaf-1, E-cadherin, N-cadherin, Vimentin antibodies to determine the relationship between above protein expression and routine clinicopathological and survival.
- Explore the involvement of SIRT1 in hormone receptor-positive human breast cancer cells at the cellular level. The molecular mechanism of EMT-related protein regulation, which affects the proliferation, invasion and metastasis of tumor cells.
Study Type
Observational
Enrollment (Anticipated)
160
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: yuan peng, Doctor
- Phone Number: +8613671287670
- Email: 13671287670@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100044
- Recruiting
- Peking University People's Hospital
-
Contact:
- yuan peng
- Phone Number: +8613671287670
- Email: 13671287670@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
all the patients have invasive breast cancer with luminal A subtype group 1: T1 and lymph node positve group 2: T2/T3 with negative lymph node
Description
Inclusion Criteria:
- Invasive breast cancer Luminal A subtype T1 and lymph node positive or T2/T3 with negative lymph node
Exclusion Criteria:
- Missing clinical pathology data
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
T1 tumor with lymph node metastasis
patients with T1 tumor and lymphnode positive
|
T2 or T3 tumor with lymph node negative
patients with T2 or T3,lymph node negative
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Protein expression difference
Time Frame: 2020-2
|
the different of sirt1 expression between T1N+ tumor and T2N0/T3M0 tumor
|
2020-2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
survival
Time Frame: 2021-2
|
the relationship of sirt1 expression level and survival
|
2021-2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: shu wang, Doctor, Peking University People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Anticipated)
December 30, 2020
Study Completion (Anticipated)
December 30, 2020
Study Registration Dates
First Submitted
October 22, 2019
First Submitted That Met QC Criteria
October 22, 2019
First Posted (Actual)
October 24, 2019
Study Record Updates
Last Update Posted (Actual)
October 24, 2019
Last Update Submitted That Met QC Criteria
October 22, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Luminal A sirt1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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