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

NCT ID: NCT04661982

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-06

Study Completion Date

2026-11-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (long term follow-up)

Patients undergo long term follow-up and complete questionnaires.

Long-term Follow-up

Intervention Type OTHER

Undergo long term follow-up

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Long-term Follow-up

Undergo long term follow-up

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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LONG-TERM FOLLOW-UP, Long-term Follow-up Quality of Life Assessment

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanne Mortimer, MD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2019-03481

Identifier Type: OTHER

Identifier Source: secondary_id

07100

Identifier Type: OTHER

Identifier Source: secondary_id

07100

Identifier Type: -

Identifier Source: org_study_id

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