Breast NeoplasmsNCT02171078
Post-Treatment Surveillance in Breast Cancer: Bringing CER to the Alliance
An observational study of Breast Neoplasms, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Nearly three million living women have survived breast cancer. Physicians rely on clinical practice guidelines to make decisions on follow-up care. Among other things, the goal is to monitor for recurrence or side effects of treatment among survivors. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- How many people
- 34,359 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2017
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Research Aim 1: Patients who have participated in 1 of 15 closed clinical trials; Research Aim 2: National Cancer Database (NCDB); Research Aim 3: Purposive sample of breast cancer survivor, breast cancer treatment provider, and cancer health services researcher stakeholders
Who may be able to join
- Women (all Aims)
- Diagnosis of breast cancer (Aims 1 \& 2)
- American Joint Committee on Cancer (AJCC) stages I-III (Aim 1) AJCC stages II-III (Aim 2)
- Patient, health care provider, and researcher stakeholders (Aim 3)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
Official title: Post-Treatment Surveillance in Breast Cancer: Bringing Cost Effectiveness Research (CER) to the Alliance
Nearly three million living women have survived breast cancer. Physicians rely on clinical practice guidelines to make decisions on follow-up care. Among other things, the goal is to monitor for recurrence or side effects of treatment among survivors. It is unclear whether these guidelines represent the best approach for any given patient as they do not account for differences in disease or patient preferences and may not consider recent advances in imaging and treatment options. We seek to develop a new approach to surveillance following breast cancer treatment which will be more patient-centered and effective than the existing one-size-fits-all approach and will consider individual risk factors.
Read the detailed description
Our project involves three primary goals:
- Use existing data from clinical trials sponsored by one of the leading cancer cooperative groups to evaluate how risk of recurrence and side effects of treatment vary based on patient and cancer characteristics.
- Use existing data to evaluate the effectiveness of the latest imaging technology for improving survival in patients previously treated for breast cancer.
- Engage cancer survivors, providers, and health outcomes researchers in the development of an improved patient-centered approach to guide post-treatment care, as well as identification of the highest priority strategies for prospective randomized trials.
Methods Our methods have been developed based on input from patients and other stakeholders who identified the need for a large-scale observational study. The goal is to produce timely results, and guide the development of an improved approach to surveillance that recognizes individual patient risk factors and allows for design of future prospective studies. This study analyzes recurrence data and treatment side effects on over 22,000 patients involved in past clinical trials on breast cancer care. The project also involves the analysis of existing data (n=15,000 patients) from a national cancer registry (National Cancer Database) to evaluate whether new imaging technology, beyond mammography, are able to detect recurrence earlier and improve survival. Finally, we will engage cancer survivors, health care providers, and researchers to develop new guidance for the care and monitoring of breast cancer survivors, and to guide and prioritize future prospective trials.
- Conditions
- Breast Neoplasms
- Keywords
- Breast Cancer, Breast Neoplasms, Health Services Research, Surveillance, Diagnostic Imaging, Magnetic Resonance Imaging, Mammography, Toxicity, Adverse Effects, Side Effects, Recurrence
- Medical subject headings
- Breast Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alliance for Clinical Trials Database | Use existing data from clinical trials sponsored by one of the leading cancer cooperative groups to evaluate how risk of recurrence and side effects of treatment vary based on patient and cancer characteristics. | |
| National Cancer Database | Use existing data to evaluate the effectiveness of the latest imaging technology for detecting recurrence and improving survival in patients previously treated for breast cancer. | |
| Stakeholder Engagement | Engage cancer survivors, providers, and health outcomes researchers in the development of an improved patient-centered approach to guide post-treatment care, as well as identification of the highest priority strategies for prospective randomized trials. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Recurrence
Data elements include the date and site of recurrence, type of recurrence (e.g., local/regional or distant recurrence), and progression.
Measured: 5 Years from Diagnosis
Time to Toxicity/Side Effects of Treatment
Legacy clinical trials contain detailed data on treatment toxicity and complications. Most trials include 2-year follow-up to determine the prevalence and time to presentation for each of the following toxicities: lymphedema, cardiotoxicity, and pneumonitis
Safety Issue?:
No
Measured: Within relevant timeframe of legacy clinical trial. Most trials include 2-year follow-up
Secondary outcomes (1)
Time to Death
Measured: Within 5 years from time of diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Other
- Time perspective
- Other
- Enrolment
- 34,359 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, American College of Surgeons, Alliance for Clinical Trials in Oncology, Harvard University, Dana-Farber Cancer Institute, M.D. Anderson Cancer Center, University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Caprice C Greenberg, MD MPH, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171078
- Sponsor's protocol ID
- 2014-0742
- Other IDs
- CE-1304-6543, UW14041, A539713, SMPH/SURGERY/SURG ONC
- Status last verified
- Dec 2022
- First submitted
- 19 Jun 2014
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Schumacher JR, Neuman HB, Yu M, Vanness DJ, Si Y, Burnside ES, Ruddy KJ, Partridge AH, Schrag D, Edge SB, Zhang Y, Jacobs EA, Havlena J, Francescatti AB, Winchester DP, McKellar DP, Spears PA, Kozower BD, Chang GJ, Greenberg CC; Alliance ACS-CRP CCDR Breast Cancer Surveillance Working Group. Surveillance Imaging vs Symptomatic Recurrence Detection and Survival in Stage II-III Breast Cancer (AFT-01). J Natl Cancer Inst. 2022 Oct 6;114(10):1371-1379. doi: 10.1093/jnci/djac131.
PubMed 35913454Schumacher JR, Wiener AA, Greenberg CC, Hanlon B, Edge SB, Ruddy KJ, Partridge AH, Le-Rademacher JG, Yu M, Vanness DJ, Yang DY, Havlena J, Strand C, Neuman HB. Local/Regional Recurrence Rates After Breast-Conserving Therapy in Patients Enrolled in Legacy Trials of the Alliance for Clinical Trials in Oncology (AFT-01). Ann Surg. 2023 May 1;277(5):841-845. doi: 10.1097/SLA.0000000000005776. Epub 2022 Dec 14.
PubMed 36521077Dudley CM, Wiener AA, Stankowski-Drengler TJ, Schumacher JR, Francescatti AB, Poore SO, Greenberg CC, Neuman HB. Rates of Ipsilateral Local-regional Recurrence in High-risk Patients Undergoing Immediate Post-mastectomy Reconstruction (AFT-01). Clin Breast Cancer. 2021 Oct;21(5):433-439. doi: 10.1016/j.clbc.2021.03.009. Epub 2021 Mar 27.
PubMed 34103255Adesoye T, Schumacher J, Greenberg CC. ASO Author Reflections: Use of Breast Imaging After Treatment for Locoregional Breast Cancer (AFT-01). Ann Surg Oncol. 2019 Dec;26(Suppl 3):553-554. doi: 10.1245/s10434-018-7070-9. Epub 2018 Dec 18. No abstract available.
PubMed 30565039Wong ML, McMurry TL, Schumacher JR, Hu CY, Stukenborg GJ, Francescatti AB, Greenberg CC, Chang GJ, McKellar DP, Walter LC, Kozower BD. Comorbidity Assessment in the National Cancer Database for Patients With Surgically Resected Breast, Colorectal, or Lung Cancer (AFT-01, -02, -03). J Oncol Pract. 2018 Oct;14(10):e631-e643. doi: 10.1200/JOP.18.00175. Epub 2018 Sep 12.
PubMed 30207852Krecko LK, Neuman HB, Greenberg CC, Wilke LG, Hanlon BM, Edge SB, Ruddy KJ, Partridge AH, Le-Rademacher J, Yang DY, Havlena J, R Schumacher J. Validation of the AJCC 8th Edition Breast Cancer Prognostic Staging System in Legacy Alliance Trials (AFT-01). Ann Surg Oncol. 2024 Sep;31(9):5880-5887. doi: 10.1245/s10434-024-15477-5. Epub 2024 Jun 2.
PubMed 38825628Neuman HB, Schumacher JR, Edge SB, Ruddy KJ, Partridge AH, Yu M, Vanness DJ, Hanlon BM, Le-Rademacher JG, Yang DY, Havlena J, Strand CA, Greenberg CC. The influence of anatomic stage and receptor status on first recurrence for breast cancer within 5 years (AFT-01). Cancer. 2023 May 1;129(9):1351-1360. doi: 10.1002/cncr.34656. Epub 2023 Mar 6.
PubMed 36872873Stankowski-Drengler TJ, Schumacher JR, Hanlon B, Livingston-Rosanoff D, Van de Walle K, Greenberg CC, Wilke LG, Neuman HB. Outcomes for Patients with Residual Stage II/III Breast Cancer Following Neoadjuvant Chemotherapy (AFT-01). Ann Surg Oncol. 2020 Mar;27(3):637-644. doi: 10.1245/s10434-019-07846-2. Epub 2020 Jan 3.
PubMed 31900808Schumacher JR, Neuman HB, Chang GJ, Kozower BD, Edge SB, Yu M, Vanness DJ, Si Y, Jacobs EA, Francescatti AB, Spears PA, Havlena J, Adesoye T, McKellar D, Winchester D, Burnside ES, Greenberg CC; Alliance ACS-CRP CCDR Breast Cancer Surveillance Working Group. A National Study of the Use of Asymptomatic Systemic Imaging for Surveillance Following Breast Cancer Treatment (AFT-01). Ann Surg Oncol. 2018 Sep;25(9):2587-2595. doi: 10.1245/s10434-018-6496-4. Epub 2018 May 17.
PubMed 29777402Adesoye T, Schumacher JR, Neuman HB, Edge S, McKellar D, Winchester DP, Francescatti AB, Greenberg CC; Alliance ACS-CRP CCDR Breast Cancer Surveillance Working Group. Use of Breast Imaging After Treatment for Locoregional Breast Cancer (AFT-01). Ann Surg Oncol. 2018 Jun;25(6):1502-1511. doi: 10.1245/s10434-018-6359-z. Epub 2018 Feb 15.
PubMed 29450753Neuman HB, Schumacher JR, Francescatti AB, Adesoye T, Edge SB, Vanness DJ, Yu M, McKellar D, Winchester DP, Greenberg CC; Alliance/American College of Surgeons Clinical Research Program Cancer Care Delivery Research Breast Cancer Surveillance Working Group. Risk of Synchronous Distant Recurrence at Time of Locoregional Recurrence in Patients With Stage II and III Breast Cancer (AFT-01). J Clin Oncol. 2018 Apr 1;36(10):975-980. doi: 10.1200/JCO.2017.75.5389. Epub 2018 Jan 31.
PubMed 29384721
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Treatment Surveillance in Breast Cancer: Bringing Cost Effectiveness Research (CER) to the Alliance
- ClinicalTrials.gov ID
- NCT02171078
- Acronym / sponsor ID
- 2014-0742
- Conditions
- Breast Neoplasms
- Keywords
- Breast Cancer, Breast Neoplasms, Health Services Research, Surveillance, Diagnostic Imaging, Magnetic Resonance Imaging, Mammography, Toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34,359 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, American College of Surgeons, Alliance for Clinical Trials in Oncology, Harvard University, Dana-Farber Cancer Institute, M.D. Anderson Cancer Center, University of North Carolina, Chapel Hill
- Study start
- Jun 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 23 Jun 2014 (estimated)
- 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.
Nearly three million living women have survived breast cancer. Physicians rely on clinical practice guidelines to make decisions on follow-up care. Among other things, the goal is to monitor for recurrence or side effects of treatment among survivors. It is unclear whether these guidelines represent the best approach for any given patient as they do not account for differences in disease or patient preferences and may not consider recent advances in imaging and treatment options. We seek to develop a new approach to surveillance following breast cancer treatment which will be more patient-centered and effective than the existing one-size-fits-all approach and will consider individual risk factors.
Detailed description
Our project involves three primary goals:
- Use existing data from clinical trials sponsored by one of the leading cancer cooperative groups to evaluate how risk of recurrence and side effects of treatment vary based on patient and cancer characteristics.
- Use existing data to evaluate the effectiveness of the latest imaging technology for improving survival in patients previously treated for breast cancer.
- Engage cancer survivors, providers, and health outcomes researchers in the development of an improved patient-centered approach to guide post-treatment care, as well as identification of the highest priority strategies for prospective randomized trials.
Methods Our methods have been developed based on input from patients and other stakeholders who identified the need for a large-scale observational study. The goal is to produce timely results, and guide the development of an improved approach to surveillance that recognizes individual patient risk factors and allows for design of future prospective studies. This study analyzes recurrence data and treatment side effects on over 22,000 patients involved in past clinical trials on breast cancer care. The project also involves the analysis of existing data (n=15,000 patients) from a national cancer registry (National Cancer Database) to evaluate whether new imaging technology, beyond mammography, are able to detect recurrence earlier and improve survival. Finally, we will engage cancer survivors, health care providers, and researchers to develop new guidance for the care and monitoring of breast cancer survivors, and to guide and prioritize future prospective trials.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alliance for Clinical Trials Database | – | –Use existing data from clinical trials sponsored by one of the leading cancer cooperative groups to evaluate how risk of recurrence and side effects of treatment vary based on patient and cancer characteristics. |
| National Cancer Database | – | –Use existing data to evaluate the effectiveness of the latest imaging technology for detecting recurrence and improving survival in patients previously treated for breast cancer. |
| Stakeholder Engagement | – | –Engage cancer survivors, providers, and health outcomes researchers in the development of an improved patient-centered approach to guide post-treatment care, as well as identification of the highest priority strategies for prospective randomized trials. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Research Aim 1: Patients who have participated in 1 of 15 closed clinical trials; Research Aim 2: National Cancer Database (NCDB); Research Aim 3: Purposive sample of breast cancer survivor, breast cancer treatment provider, and cancer health services researcher stakeholders
Key inclusion criteria (4 listed)
- Women (all Aims)
- Diagnosis of breast cancer (Aims 1 \& 2)
- American Joint Committee on Cancer (AJCC) stages I-III (Aim 1) AJCC stages II-III (Aim 2)
- Patient, health care provider, and researcher stakeholders (Aim 3)
Key exclusion criteria (1 listed)
- None
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
Time to Recurrence
Time frame: 5 Years from Diagnosis
Data elements include the date and site of recurrence, type of recurrence (e.g., local/regional or distant recurrence), and progression.
Time to Toxicity/Side Effects of Treatment
Time frame: Within relevant timeframe of legacy clinical trial. Most trials include 2-year follow-up
Legacy clinical trials contain detailed data on treatment toxicity and complications. Most trials include 2-year follow-up to determine the prevalence and time to presentation for each of the following toxicities: lymphedema, cardiotoxicity, and pneumonitis Safety Issue?: No
1 secondary outcome
Time to Death
Time frame: Within 5 years from time of diagnosis
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 27 Dec 2022.
- Results publication: PubMed 35913454Schumacher JR, Neuman HB, Yu M, Vanness DJ, Si Y, Burnside ES, Ruddy KJ, Partridge AH, Schrag D, Edge SB, Zhang Y, Jacobs EA, Havlena J, Francescatti AB, Winchester DP, McKellar DP, Spears PA, Kozower BD, Chang GJ, Greenberg CC; Alliance ACS-CRP CCDR Breast Cancer Surveillance Working Group. Surveillance Imaging vs Symptomatic Recurrence Detection and Survival in Stage II-III Breast Cancer (AFT-01). J Natl Cancer Inst. 2022 Oct 6;114(10):1371-1379. doi: 10.1093/jnci/djac131.
- Results publication: PubMed 36521077Schumacher JR, Wiener AA, Greenberg CC, Hanlon B, Edge SB, Ruddy KJ, Partridge AH, Le-Rademacher JG, Yu M, Vanness DJ, Yang DY, Havlena J, Strand C, Neuman HB. Local/Regional Recurrence Rates After Breast-Conserving Therapy in Patients Enrolled in Legacy Trials of the Alliance for Clinical Trials in Oncology (AFT-01). Ann Surg. 2023 May 1;277(5):841-845. doi: 10.1097/SLA.0000000000005776. Epub 2022 Dec 14.
- Results publication: PubMed 34103255Dudley CM, Wiener AA, Stankowski-Drengler TJ, Schumacher JR, Francescatti AB, Poore SO, Greenberg CC, Neuman HB. Rates of Ipsilateral Local-regional Recurrence in High-risk Patients Undergoing Immediate Post-mastectomy Reconstruction (AFT-01). Clin Breast Cancer. 2021 Oct;21(5):433-439. doi: 10.1016/j.clbc.2021.03.009. Epub 2021 Mar 27.
- Results publication: PubMed 30565039Adesoye T, Schumacher J, Greenberg CC. ASO Author Reflections: Use of Breast Imaging After Treatment for Locoregional Breast Cancer (AFT-01). Ann Surg Oncol. 2019 Dec;26(Suppl 3):553-554. doi: 10.1245/s10434-018-7070-9. Epub 2018 Dec 18. No abstract available.
- Results publication: PubMed 30207852Wong ML, McMurry TL, Schumacher JR, Hu CY, Stukenborg GJ, Francescatti AB, Greenberg CC, Chang GJ, McKellar DP, Walter LC, Kozower BD. Comorbidity Assessment in the National Cancer Database for Patients With Surgically Resected Breast, Colorectal, or Lung Cancer (AFT-01, -02, -03). J Oncol Pract. 2018 Oct;14(10):e631-e643. doi: 10.1200/JOP.18.00175. Epub 2018 Sep 12.
- Derived from this study: PubMed 38825628Krecko LK, Neuman HB, Greenberg CC, Wilke LG, Hanlon BM, Edge SB, Ruddy KJ, Partridge AH, Le-Rademacher J, Yang DY, Havlena J, R Schumacher J. Validation of the AJCC 8th Edition Breast Cancer Prognostic Staging System in Legacy Alliance Trials (AFT-01). Ann Surg Oncol. 2024 Sep;31(9):5880-5887. doi: 10.1245/s10434-024-15477-5. Epub 2024 Jun 2.
- Derived from this study: PubMed 36872873Neuman HB, Schumacher JR, Edge SB, Ruddy KJ, Partridge AH, Yu M, Vanness DJ, Hanlon BM, Le-Rademacher JG, Yang DY, Havlena J, Strand CA, Greenberg CC. The influence of anatomic stage and receptor status on first recurrence for breast cancer within 5 years (AFT-01). Cancer. 2023 May 1;129(9):1351-1360. doi: 10.1002/cncr.34656. Epub 2023 Mar 6.
- Derived from this study: PubMed 31900808Stankowski-Drengler TJ, Schumacher JR, Hanlon B, Livingston-Rosanoff D, Van de Walle K, Greenberg CC, Wilke LG, Neuman HB. Outcomes for Patients with Residual Stage II/III Breast Cancer Following Neoadjuvant Chemotherapy (AFT-01). Ann Surg Oncol. 2020 Mar;27(3):637-644. doi: 10.1245/s10434-019-07846-2. Epub 2020 Jan 3.
- Derived from this study: PubMed 29777402Schumacher JR, Neuman HB, Chang GJ, Kozower BD, Edge SB, Yu M, Vanness DJ, Si Y, Jacobs EA, Francescatti AB, Spears PA, Havlena J, Adesoye T, McKellar D, Winchester D, Burnside ES, Greenberg CC; Alliance ACS-CRP CCDR Breast Cancer Surveillance Working Group. A National Study of the Use of Asymptomatic Systemic Imaging for Surveillance Following Breast Cancer Treatment (AFT-01). Ann Surg Oncol. 2018 Sep;25(9):2587-2595. doi: 10.1245/s10434-018-6496-4. Epub 2018 May 17.
- Derived from this study: PubMed 29450753Adesoye T, Schumacher JR, Neuman HB, Edge S, McKellar D, Winchester DP, Francescatti AB, Greenberg CC; Alliance ACS-CRP CCDR Breast Cancer Surveillance Working Group. Use of Breast Imaging After Treatment for Locoregional Breast Cancer (AFT-01). Ann Surg Oncol. 2018 Jun;25(6):1502-1511. doi: 10.1245/s10434-018-6359-z. Epub 2018 Feb 15.
- Derived from this study: PubMed 29384721Neuman HB, Schumacher JR, Francescatti AB, Adesoye T, Edge SB, Vanness DJ, Yu M, McKellar D, Winchester DP, Greenberg CC; Alliance/American College of Surgeons Clinical Research Program Cancer Care Delivery Research Breast Cancer Surveillance Working Group. Risk of Synchronous Distant Recurrence at Time of Locoregional Recurrence in Patients With Stage II and III Breast Cancer (AFT-01). J Clin Oncol. 2018 Apr 1;36(10):975-980. doi: 10.1200/JCO.2017.75.5389. Epub 2018 Jan 31.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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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.
Caprice C Greenberg, MD MPH principal investigator
University of Wisconsin, Madison
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 Breast Neoplasms, run by University of Wisconsin, Madison 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 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 27 Dec 2022. 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?
Time to Recurrence (time frame: 5 Years from Diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02171078, which also lists 11 linked publications.
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 27 Dec 2022.