NCT04137406

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

October 24, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

October 22, 2019

Last Update Submit

October 22, 2019

Conditions

Keywords

Luminal A breast cancerSirt 1lymph node metastasisEMT

Outcome Measures

Primary Outcomes (1)

  • Protein expression difference

    the different of sirt1 expression between T1N+ tumor and T2N0/T3M0 tumor

    2020-2

Secondary Outcomes (1)

  • survival

    2021-2

Study Arms (2)

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

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Invasive breast cancer Luminal A subtype T1 and lymph node positive or T2/T3 with negative lymph node

You may not qualify if:

  • Missing clinical pathology data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking university people's hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Paraffin section, immunohistochemical staining

MeSH Terms

Conditions

Breast NeoplasmsLymphatic Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • shu wang, Doctor

    Peking University People's Hospital

    STUDY DIRECTOR

Central Study Contacts

yuan peng, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 24, 2019

Study Start

January 1, 2019

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

October 24, 2019

Record last verified: 2019-10

Locations