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Clinical Trials/NCT04033965
NCT04033965CompletedNot Applicable

Tumor Mutational Patterns and Infiltrating Lymphocyte Density in Young and Old Patients With Breast Cancer

Hellenic Cooperative Oncology Group0 sites345 target enrollmentStarted: September 3, 1997Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
345
Primary Endpoint
Assessment of the prevalence of gene mutations in women <=35 years old with early breast cancer.

Study Overview

Brief Summary

Age may pertain to different tumor genotype characteristics which may interfere with treatment efficacy and prognosis. The investigators investigated the distribution and prognostic effect of mutations (mut) and tumor infiltrating lymphocyte (TILs) in young and elderly early breast cancer patients (pts).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • women with early breast cancer <35 years old or >65 years old

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Assessment of the prevalence of gene mutations in women <=35 years old with early breast cancer.

Time Frame: Up to 13 years

Assessment of the prevalence of gene mutations in women >65years old with early breast cancer.

Time Frame: Up to 13 years

Evaluation of Tumor Infiltrating Lymphocytes (TILs) density using descriptive statistics in women <=35 years old with early breast cancer.

Time Frame: Up to 13 years

Evaluation of Tumor Infiltrating Lymphocytes (TILs) density using descriptive statistics in women >65 years old with early breast cancer.

Time Frame: Up to 13 years

Evaluation of the prognostic effect of gene mutations and Tumor Infiltrating Lymphocytes with respect to Overall Survival in women <=35 years old with early breast cancer

Time Frame: Up to 13 years

Evaluation of the prognostic effect of gene mutations and Tumor Infiltrating Lymphocytes with respect to Overall Survival in women >65 years old with early breast cancer.

Time Frame: Up to 13 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hellenic Cooperative Oncology Group
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Manto Nikolaidi

Medical Oncologist

Hellenic Cooperative Oncology Group

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