Clinical trial NCT04033965: Corellation of Mutations, TILs and Age in Breast Cancer
Official title: Tumor Mutational Patterns and Infiltrating Lymphocyte Density in Young and Old Patients With Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 345
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women with early breast cancer \<35 years old or \>65 years old

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).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* NA

Primary outcomes:
measure: Assessment of the prevalence of gene mutations in women <=35 years old with early breast cancer.
timeFrame: Up to 13 years
measure: Assessment of the prevalence of gene mutations in women >65years old with early breast cancer.
timeFrame: Up to 13 years
measure: Evaluation of Tumor Infiltrating Lymphocytes (TILs) density using descriptive statistics in women <=35 years old with early breast cancer.
timeFrame: Up to 13 years
measure: Evaluation of Tumor Infiltrating Lymphocytes (TILs) density using descriptive statistics in women >65 years old with early breast cancer.
timeFrame: Up to 13 years
measure: 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
timeFrame: Up to 13 years
measure: 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.
timeFrame: Up to 13 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Oncology Department, MITERA Hospital
name: Adamantia Nikolaidi, MD
role: PRINCIPAL_INVESTIGATOR
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