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

NCT04661982 | Active Not Recruiting DMC

• 2 other identifiers: 07100NCI-2019-03481
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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

• FACT- Cog

  Functional Assessment of Cancer Therapy Cognitive Function

  Change from pre-treatment baseline over a 2-year period

• Cancer induced immune dysfunction

  Will analyze patients' tumor, lymph node, and blood samples

  Up to 12 years

Study Arms (1)

Observational (long term follow-up)

Patients undergo long term follow-up and complete questionnaires.

Other: Long-term Follow-up; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Interventions

Long-term Follow-up OTHER

Undergo long term follow-up

Also known as: LONG-TERM FOLLOW-UP, Long-term Follow-up

Observational (long term follow-up)

Questionnaire Administration OTHER

Ancillary studies

Observational (long term follow-up)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Observational (long term follow-up)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stage 0-IIIC breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor, lymph node, blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joanne Mortimer, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: December 10, 2020
• Study Start: July 6, 2010
• Primary Completion (Estimated): November 24, 2026
• Study Completion (Estimated): November 24, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (1)