Long Term Follow-Up in Patients With Stage 0-IIIC Breast Cancer

Breast Cancer Clinical Trial

Official title:

Long Term Follow Up After Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04661982
• Other study ID #: 07100
• Secondary ID: NCI-2019-0348107
• Status: Active, not recruiting
• Start date: July 6, 2010
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This trial studies long term follow-up care in patients with stage 0-IIIC breast cancer. Collecting feedback from breast cancer patients may help researchers to define comprehensive long term follow-up care for breast cancer survivors, better understand health-related quality of life and long-term complications in breast cancer survivors, and to increase the knowledge of the mechanisms by which a patient's own immune system attempts to combat breast cancer, and what factors may make this response more successful.

Description:

PRIMARY OBJECTIVES: I. To provide comprehensive care to breast cancer survivors diagnosed with stage 0 to IIIC, who received at least part of their treatment at City of Hope. II. To use the information obtained from follow-up of breast cancer survivors to describe the magnitude of risk and associated risk factors. III. To use the information gained from follow-up of breast cancer survivors to describe health-related quality of life (HRQL) concerns in breast cancer survivors and identify those at highest risk. OUTLINE: Patients undergo long term follow-up and complete questionnaires.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of breast cancer, stage 0-IIIC
• Partial or entire treatment at City of Hope
• Must be registered before adjuvant therapy and ideally before definitive local therapy

Exclusion Criteria:

• Stage IV breast cancer
• Recurrent breast cancer
• Prior cancers, chemotherapy or radiation * (Note: Subjects who develop locoregional or systemic recurrence while enrolled on this protocol will be withdrawn, and will continue their care with their primary oncology providers only)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Long-term Follow-up
Undergo long term follow-up
• Questionnaire Administration
Ancillary studies
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (1)

Lead Sponsor	Collaborator
City of Hope Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rates of the study end-points	Will estimation of incidence rates of the study end-points that may be associated with original diagnosis or treatment received, and delineation of temporal changes in serial measurements and their relationship to time-invariant characteristics such as original diagnosis, race, and education and time varying characteristics such as age and body mass index (BMI). Incidence rates may be compared with national standards adjusted for key demographic variables and between patient subgroups. Time of entry onto the study in the analysis will be from the date of diagnosis of primary disease. Stepwise logistic regression analysis of endpoints of interest at certain follow-up time may be conducted, accounting for the joint effect of such factors as age, time since diagnosis and treatment, radiation dose, chemotherapy and tumor subtype.	Up to 12 years
Primary	FACT- Cog	Functional Assessment of Cancer Therapy Cognitive Function	Change from pre-treatment baseline over a 2-year period
Primary	Cancer induced immune dysfunction	Will analyze patients' tumor, lymph node, and blood samples	Up to 12 years