Anatomic Stage I Breast Cancer AJCC v8NCT05786664
Breast Cancer Survivorship Biorepository
An observational study of Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Southern California at 1 site in United States.
Trial summary
This study collects blood samples as well as clinical and self-report data from stage I-III breast cancer survivors to create a biorepository for future use. The creation of this biorepository will allow for future research into links between individual, molecular, and genomic signatures and cancer outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Electronic Health Record Review and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- How many people
- 1,300 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2022to 11 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult women diagnosed with invasive breast cancer (stages I-III) who have completed active treatment.
Who may be able to join
- Women of all racial and ethnic groups 18 years of age or older
- Women with a diagnosis of invasive breast cancer (stages I-III) within the past 7 years
- Women who have completed active treatment for breast cancer (surgery, chemotherapy, HER2-directed therapy and radiation)
- Prior participation on clinical trials is allowed
Who cannot join
- Current receipt of interventional clinical trial participation
- Stage IV (metastatic) cancer
- Prior history of recurrence (except recurrence following ductal carcinoma in situ)
- Inability to give informed consent
- Unable to speak English, Spanish, Chinese, or Korean
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Audrey Saghian, MPH, 323-865-6086, Amsaghia@usc.edu
Bodour Salhia, PhD
About this study
Official title: A Comprehensive Breast Cancer Survivorship Biorepository
This study collects blood samples as well as clinical and self-report data from stage I-III breast cancer survivors to create a biorepository for future use. The creation of this biorepository will allow for future research into links between individual, molecular, and genomic signatures and cancer outcomes.
Read the detailed description
PRIMARY OBJECTIVE:
- To create an annotated biorepository with prospectively collected blood samples from breast cancer survivors.
SECONDARY OBJECTIVES:
- To collect comprehensive data on social determinants of health (e.g., race/ethnicity, acculturation, socioeconomic status, and access to care), environmental exposures (based on zip codes/geocoding), lifestyle (e.g., diet, tobacco use), clinicopathologic characteristics, treatment history, follow-up and current disease status, survivorship-related issues.
II. To establish an efficient process for researchers to utilize the biorepository for breast cancer and survivorship-related studies.
OUTLINE:
Patients complete surveys, undergo collection of blood samples, and review of medical records on study.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Invasive Breast Carcinoma
- Being tested
- Biospecimen Collection, Electronic Health Record Review, Quality-of-Life Assessment, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood samples
Electronic Health Record ReviewOther
Review of records
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete quality-of-life questionnaires
Survey AdministrationOther
Complete surveys
| Study group | Role | What they receive |
|---|---|---|
| Observational (survey, biospecimen collection, record review) | Patients complete surveys, undergo collection of blood samples, and review of medical records on study. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Quality-of-Life Assessment; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biorepository
Number of biological samples collected and stored (blood)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start11 Apr 2022
- Primary completion11 Apr 2027 (estimated)
- Study completion11 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bodour Salhia, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786664
- Sponsor's protocol ID
- 1B-21-6
- Other IDs
- NCI-2021-13442, 1B-21-6, P30CA014089
- Status last verified
- May 2026
- First submitted
- 15 Mar 2023
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Breast Cancer Survivorship Biorepository
- ClinicalTrials.gov ID
- NCT05786664
- Acronym / sponsor ID
- 1B-21-6
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Invasive Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 11 Apr 2027 (estimated)
- Study completion
- 11 Apr 2028 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study collects blood samples as well as clinical and self-report data from stage I-III breast cancer survivors to create a biorepository for future use. The creation of this biorepository will allow for future research into links between individual, molecular, and genomic signatures and cancer outcomes.
Detailed description
PRIMARY OBJECTIVE:
- To create an annotated biorepository with prospectively collected blood samples from breast cancer survivors.
SECONDARY OBJECTIVES:
- To collect comprehensive data on social determinants of health (e.g., race/ethnicity, acculturation, socioeconomic status, and access to care), environmental exposures (based on zip codes/geocoding), lifestyle (e.g., diet, tobacco use), clinicopathologic characteristics, treatment history, follow-up and current disease status, survivorship-related issues.
II. To establish an efficient process for researchers to utilize the biorepository for breast cancer and survivorship-related studies.
OUTLINE:
Patients complete surveys, undergo collection of blood samples, and review of medical records on study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (survey, biospecimen collection, record review) | – | Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Other: Quality-of-Life Assessment, Other: Survey AdministrationPatients complete surveys, undergo collection of blood samples, and review of medical records on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women diagnosed with invasive breast cancer (stages I-III) who have completed active treatment.
Key inclusion criteria (4 listed)
- Women of all racial and ethnic groups 18 years of age or older
- Women with a diagnosis of invasive breast cancer (stages I-III) within the past 7 years
- Women who have completed active treatment for breast cancer (surgery, chemotherapy, HER2-directed therapy and radiation)
- Prior participation on clinical trials is allowed
Key exclusion criteria (5 listed)
- Current receipt of interventional clinical trial participation
- Stage IV (metastatic) cancer
- Prior history of recurrence (except recurrence following ductal carcinoma in situ)
- Inability to give informed consent
- Unable to speak English, Spanish, Chinese, or Korean
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood samples | Procedure or surgery | Observational (survey, biospecimen collection, record review) |
| Electronic Health Record ReviewReview of records | Other | Observational (survey, biospecimen collection, record review) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete quality-of-life questionnaires | Other | Observational (survey, biospecimen collection, record review) |
| Survey AdministrationComplete surveys | Other | Observational (survey, biospecimen collection, record review) |
Primary outcome
Biorepository
Time frame: 5 years
Number of biological samples collected and stored (blood)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bodour Salhia, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Audrey Saghian, MPH (323-865-6086, amsaghia@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biorepository (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.