NCT04322331

Brief Summary

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.

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 24, 2020

Last Update Submit

March 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Transcriptional Characterization

    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

Study Arms (2)

T1N+

T1 tumor with positive lymph node,N1/N2/N3

Other: no intervention

T2/T3N0

T2/T3 tumor with negative lymph node

Other: no intervention

Interventions

no intervention

T1N+T2/T3N0

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Missing specimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking university people's hospital

Beijing, China

Location

MeSH Terms

Conditions

Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 26, 2020

Study Start

May 1, 2020

Primary Completion

May 1, 2021

Study Completion

December 31, 2021

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations