 |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05730010 |
|
Recruitment Status : **RECRUITING NOW**
First Posted : February 15, 2023 Last Update Posted : February 15, 2023 |
Sponsor:
Information provided by (Responsible Party):
Tarah J Ballinger, MD, Indiana University
Brief 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.
| Triple Negative Breast Cancer |
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 Type : | Observational |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Cross-Sectional |
| Official Title: | Discerning the Impact of ctDNA Detection on Patient Decision Making in Early Stage Breast Cancer: a Conjoint Analysis |
| Actual Study Start Date : | January 18, 2023 |
| Estimated Primary Completion Date : | July 31, 2023 |
| Estimated Study Completion Date : | July 31, 2023 |
- 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.
- 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 ]
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study:  | 18 Years and older  (Adult, Older Adult) |
| Sexes Eligible for Study: Â | All |
| Accepts Healthy Volunteers: Â | No |
| Sampling Method: Â | Probability Sample |
Approximately 200 subjects will be recruited by Research Advocacy Network (RAN) and their partner organizations through email and social media solicitation.
Inclusion Criteria:
- 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
Exclusion Criteria:
N/A
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05730010
| Contact: Tarah Ballinger, MD | (317) 944-3553 | tarahb@iu.edu |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: Tarah Ballinger, MD Â Â Â Â Â Â | |
Indiana University
| Responsible Party: | Tarah J Ballinger, MD, Assistant Professor of Clinical Medicine, Indiana University |
| ClinicalTrials.gov Identifier: | NCT05730010 Â Â |
| Other Study ID Numbers: | CTO-IUSCCC-0803 |
| First Posted: | February 15, 2023 Â Â Key Record Dates |
| Last Update Posted: | February 15, 2023 |
| Last Verified: | February 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Tarah J Ballinger, MD, Indiana University:
| breast cancer, ctDNA |
Additional relevant MeSH terms:
| Breast Neoplasms Triple Negative Breast Neoplasms Neoplasms by Site |
Neoplasms Breast Diseases Skin Diseases |
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
