Corellation of Mutations, TILs and Age in Breast Cancer

• Sponsor: Hellenic Cooperative Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT04033965
• Collaborator: (none)
• Enrollment: 345
• Actual Duration (Months): 156.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Genetic: Corellation of Mutations, TILs and Age in Breast Cancer

Study Design

• Study Type: Observational
• Actual Enrollment: 345 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Tumor Mutational Patterns and Infiltrating Lymphocyte Density in Young and Old Patients With Breast Cancer
• Actual Study Start Date: Sep 3, 1997
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
women <35 with early breast cancer	Genetic: Corellation of Mutations, TILs and Age in Breast Cancer
women>65 years old with early breast cancer	Genetic: Corellation of Mutations, TILs and Age in Breast Cancer

Outcome Measures

Primary Outcome Measures

1. Assessment of the prevalence of gene mutations in women <=35 years old with early breast cancer. [Up to 13 years]

2. Assessment of the prevalence of gene mutations in women >65years old with early breast cancer. [Up to 13 years]

3. Evaluation of Tumor Infiltrating Lymphocytes (TILs) density using descriptive statistics in women <=35 years old with early breast cancer. [Up to 13 years]

4. Evaluation of Tumor Infiltrating Lymphocytes (TILs) density using descriptive statistics in women >65 years old with early breast cancer. [Up to 13 years]

5. 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]

6. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• NA

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hellenic Cooperative Oncology Group

Investigators

• Principal Investigator: Adamantia Nikolaidi, MD, Oncology Department, MITERA Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: Manto Nikolaidi, Medical Oncologist, Hellenic Cooperative Oncology Group
• ClinicalTrials.gov Identifier: NCT04033965
• Other Study ID Numbers: HE10/mut
• First Posted: Jul 26, 2019
• Last Update Posted: Jul 26, 2019
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jul 26, 2019