Tumor Immune Mechanism of Axillary Lymph Node Metastasis in Early Luminal Type A Breast Cancer

March 27, 2020 updated by: Peking University People's Hospital

The Different Transcriptional Characterization Of The Tumor Immune Microenvironment of Luminal A Breast Cancer With Different Lymph Node Metastasas Status

Luminal type A breast cancer is a type with good clinical prognosis, and the proportion of lymph node metastasis is low, but a small number of patients have more lymph node metastasis when the primary tumor is very small, and the survival is poor, suggesting that this part of Luminal A breast cancer has the different expression of some genes from that of general Luminal A breast cancer, which affects tumor invasion and participates in the occurrence of tumor metastasis. But the mechanism is not clear, especially in the current tumor microenvironment and immune related mechanisms.We want to investigated the relationship of the transcriptional tumor immune microenvironment with early lymph node metastasis among Luminal A type breast cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University People's Hospital

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

Probability Sample

Study Population

invasive breast cancer patients with Luminal A type. Stage T1N1/T1N2/T1N3 are in group 1; stage T2N0/T3N0 are in group 2

Description

Inclusion Criteria:

  • invasive breast cancer with Luminal A type;T1 with positive lymph node or T2/T3 with negative lymph node

Exclusion Criteria:

  • Missing specimen

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
T1N+
T1 tumor with positive lymph node,N1/N2/N3
Other: no intervention
no intervention
T2/T3N0
T2/T3 tumor with negative lymph node
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcriptional Characterization
Time Frame: 2020-12
the relationship of the transcriptional tumor immune microenvironment with lymph node metastases in Luminal A breast tumor;Differences in RNA copy numbers of different genes （using IO Panel） between the two groups of patients
2020-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 (Anticipated)

May 1, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

March 24, 2020

First Submitted That Met QC Criteria

March 24, 2020

First Posted (Actual)

March 26, 2020

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IO Panel

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Study Protocol

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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