Corellation of Mutations, TILs and Age in Breast Cancer

Completed

• Conditions: Breast Cancer
• Interventions: Genetic: Corellation of Mutations, TILs and Age in Breast Cancer

• Registration Number: NCT04033965
• Lead Sponsor: Hellenic Cooperative Oncology Group

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).

Detailed Description

Not available

Study Timeline

• Study Start: 1997-09-03
• Primary Completion: 2010-10-01
• Study Completion: 2010-10-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-25
• Last Update Submitted: 2019-07-25
• Study First Posted: 2019-07-26
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 345

Inclusion Criteria

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

Exclusion Criteria

• NA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
women <35 with early breast cancer	Corellation of Mutations, TILs and Age in Breast Cancer	-
women>65 years old with early breast cancer	Corellation of Mutations, TILs and Age in Breast Cancer	-

Primary Outcome Measures

Name	Time	Method
Assessment of the prevalence of gene mutations in women <=35 years old with early breast cancer.	Up to 13 years
Assessment of the prevalence of gene mutations in women >65years old with early breast cancer.	Up to 13 years
Evaluation of Tumor Infiltrating Lymphocytes (TILs) density using descriptive statistics in women <=35 years old with early breast cancer.	Up to 13 years
Evaluation of Tumor Infiltrating Lymphocytes (TILs) density using descriptive statistics in women >65 years old with early breast cancer.	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	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.	Up to 13 years