Triple Negative Breast CancerNCT05730010
Discerning the Impact of ctDNA Detection on Patient Decision Making in Early Stage Breast Cancer: a Conjoint Analysis
An observational study of Triple Negative Breast Cancer, run by Indiana University at 1 site in United States.
Trial summary
This study will examine how ctDNA and additional prognostic genomic information in patients with early stage breast cancer might influences patient decision- making regarding systemic therapy options. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer
- How many people
- 289 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2023to 26 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 200 subjects will be recruited by Research Advocacy Network (RAN) and their partner organizations through email and social media solicitation.
Who may be able to join
- Self- reported history of non-metastatic breast cancer
- Self- reported history of receiving chemotherapy for breast cancer
- Self- reported history of chemotherapy completed at least 6 months ago but no more than 10 years ago
- Able to complete an online survey
- English speaking
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
About this study
This study will examine how ctDNA and additional prognostic genomic information in patients with early stage breast cancer might influences patient decision- making regarding systemic therapy options.
Read the detailed description
This study is an electronically delivered, one time cross sectional survey study. The investigators want to understand how patients with triple negative breast cancer at high risk for disease recurrence will prioritize additional benefit over toxicity when considering treatment options, and if their knowledge of ctDNA positivity versus negativity will further shift this balance toward benefit.
- Conditions
- Triple Negative Breast Cancer
- Keywords
- breast cancer, ctDNA
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine whether knowledge of ctDNA negativity influences patient decision-making
Ratings- based analysis will be used to examine whether knowledge of ctDNA negativity increases patient acceptability (and if so, by how much) of no therapy in the adjuvant setting, compared to standard of care capecitabine.
Measured: Once all surveys in the sample size are completed, 6 months anticipated
Secondary outcomes (1)
Estimate at what degree of benefit a given treatment would be acceptable to patients
When assuming risk of recurrence of ctDNA positivity, we will use ratings- based conjoint analysis to determine part-worth utilities of each attribute - potential toxicity and potential benefit. Comparison of part-worth utilities will be used to estimate at what degree of benefit a given treatment would be acceptable, which will inform future trials.
Measured: Once all surveys in the sample size are completed, 6 months anticipated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start16 Apr 2023
- Primary completion26 Jun 2023
- Study completion26 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Cross-sectional
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarah J Ballinger, MD, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730010
- Sponsor's protocol ID
- CTO-IUSCCC-0803
- Status last verified
- Aug 2023
- First submitted
- 31 Jan 2023
- Last updated
- 3 Aug 2023
- 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 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discerning the Impact of ctDNA Detection on Patient Decision Making in Early Stage Breast Cancer: a Conjoint Analysis
- ClinicalTrials.gov ID
- NCT05730010
- Acronym / sponsor ID
- CTO-IUSCCC-0803
- Conditions
- Triple Negative Breast Cancer
- Keywords
- breast cancer, ctDNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 16 Apr 2023 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 15 Feb 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 will examine how ctDNA and additional prognostic genomic information in patients with early stage breast cancer might influences patient decision- making regarding systemic therapy options.
Detailed description
This study is an electronically delivered, one time cross sectional survey study. The investigators want to understand how patients with triple negative breast cancer at high risk for disease recurrence will prioritize additional benefit over toxicity when considering treatment options, and if their knowledge of ctDNA positivity versus negativity will further shift this balance toward benefit.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 200 subjects will be recruited by Research Advocacy Network (RAN) and their partner organizations through email and social media solicitation.
Key inclusion criteria (5 listed)
- Self- reported history of non-metastatic breast cancer
- Self- reported history of receiving chemotherapy for breast cancer
- Self- reported history of chemotherapy completed at least 6 months ago but no more than 10 years ago
- Able to complete an online survey
- English speaking
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Examine whether knowledge of ctDNA negativity influences patient decision-making
Time frame: Once all surveys in the sample size are completed, 6 months anticipated
Ratings- based analysis will be used to examine whether knowledge of ctDNA negativity increases patient acceptability (and if so, by how much) of no therapy in the adjuvant setting, compared to standard of care capecitabine.
1 secondary outcome
Estimate at what degree of benefit a given treatment would be acceptable to patients
Time frame: Once all surveys in the sample size are completed, 6 months anticipated
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Triple Negative Breast Cancer, run by Indiana University 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 3 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examine whether knowledge of ctDNA negativity influences patient decision-making (time frame: Once all surveys in the sample size are completed, 6 months anticipated). 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 3 Aug 2023.