All > Montana > Greensboro

Active Monitoring for Ductal Carcinoma

Aurora Health Care, Aurora Cancer Care, Oshkosh, WI
Targeting 2 different conditionsActive Monitoring +1 moreN/AWaitlist AvailableLed by Shelley Hwang, MD, MPHResearch Sponsored by Alliance Foundation Trials, LLC.

Study Summary

This trial looks at whether active monitoring or surgery is better for low-risk DCIS. The hypothesis is that active monitoring does not lead to worse outcomes.

Eligible Conditions
  • Ductal Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2, 5, and 7 year follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2, 5, and 7 year follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Upper arm
Secondary outcome measures
Breast cancer specific survival rate
Breast conservation rate
Contralateral invasive cancer rate
+10 more
Other outcome measures
Adherence to hormonal therapy
Body image
Breast MRI utilization rate
+14 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Active MonitoringExperimental Treatment1 Intervention
DCIS - Choice for endocrine therapy (MMG q 6 months x 5 years GCC for invasive progression)
Group II: SurgeryActive Control1 Intervention
DCIS - Surgery +/- radiation choice for endocrine therapy (MMG q 12 months x 5 years usual care for recurrent disease)

Find a site

Who is running the clinical trial?

Alliance Foundation Trials, LLC.Lead Sponsor
23 Previous Clinical Trials
24,119 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
521 Previous Clinical Trials
29,915,888 Total Patients Enrolled
Duke UniversityOTHER
2,275 Previous Clinical Trials
3,091,293 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,040 Previous Clinical Trials
762,762 Total Patients Enrolled
M.D. Anderson Cancer CenterOTHER
2,872 Previous Clinical Trials
1,780,049 Total Patients Enrolled
New York UniversityOTHER
214 Previous Clinical Trials
311,310 Total Patients Enrolled
Washington University School of MedicineOTHER
1,874 Previous Clinical Trials
2,275,586 Total Patients Enrolled
Shelley Hwang, MD, MPHPrincipal Investigator
Duke University
1 Previous Clinical Trials
108 Total Patients Enrolled
Ann Partridge, MD, MPHStudy Chair
Dana-Farber Cancer Institute
Alastair Thompson, MDStudy Chair
Baylor College of Medicine

Media Library

Active Monitoring Clinical Trial Eligibility Overview. Trial Name: NCT02926911 — N/A
Ductal Carcinoma Research Study Groups: Surgery, Active Monitoring
Ductal Carcinoma Clinical Trial 2023: Active Monitoring Highlights & Side Effects. Trial Name: NCT02926911 — N/A
Active Monitoring 2023 Treatment Timeline for Medical Study. Trial Name: NCT02926911 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be met for someone to qualify for participation in this experiment?

"Aspiring participants of this trial should have ductal carcinoma and be within the ages of 40-99. The protocol is accepting a maximum enrollment count of 1200 people."

Answered by AI

To what extent is the participant roster of this study being populated?

"This clinical trial necessitates 1200 eligible patients. Allowing for multiple locations, individuals may join the study from New York-Presbyterian Weill Cornell Medical Center in NYC and Community Medical Center in Missoula, MT."

Answered by AI

Are seniors being asked to be part of this experiment?

"This clinical study is in search of subjects aged between 40 and 99 years old."

Answered by AI

Is this clinical investigation actively seeking new participants?

"Affirmative. Clinicaltrials.gov exhibits that this medical investigation is actively seeking volunteers, since it was established on February 22nd 2017 and last updated September 19th 2022. The trial necessitates 1200 individuals to be accepted at 100 individual centres."

Answered by AI

How many facilities are currently hosting this experiment?

"This clinical trial is running out of New York-Presbyterian Weill Cornell Medical Center in Manhattan, Community Medical Center in Missoula, Montana, Saint Joseph Hospital- Cancer Centers of Colorado in Lafayette, Colorado and a hundred other medical sites."

Answered by AI

Who else is applying?

What state do they live in?
New Hampshire
New Jersey
How old are they?
18 - 65
What site did they apply to?
New Hampshire Oncology Hematology PA
Jersey Shore University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
Breast Cancer Research and TreatmentJournal
Characterizing the Impact of 25 Years of DCIS Treatment
Ozanne, Elissa M., Yiwey Shieh, James Barnes, Colleen Bouzan, E. Shelley Hwang, and Laura J. Esserman. 2011. “Characterizing the Impact of 25 Years of DCIS Treatment”. Breast Cancer Research and Treatment. Springer Science and Business Media LLC. doi:10.1007/s10549-011-1430-5.
The LancetJournal
Breast Cancer Screening with Mammography: Overview of Swedish Randomised Trials
Nyström, L., S. Wall, L.E. Rutqvist, A. Lindgren, M. Lindqvist, S. Rydén, J. Andersson, et al.. 1993. “Breast Cancer Screening with Mammography: Overview of Swedish Randomised Trials”. The Lancet. Elsevier BV. doi:10.1016/0140-6736(93)91067-v.
CancerSpectrum Knowledge EnvironmentJournal
Detection of Ductal Carcinoma in Situ in Women Undergoing Screening Mammography
Ernster, V. L.. 2002. “Detection of Ductal Carcinoma in Situ in Women Undergoing Screening Mammography”. Cancerspectrum Knowledge Environment. Oxford University Press (OUP). doi:10.1093/jnci/94.20.1546.
BMJ OpenJournal
The COMET (comparison of Operative Versus Monitoring and Endocrine Therapy) Trial: A Phase III Randomised Controlled Clinical Trial for Low-risk Ductal Carcinoma in Situ (DCIS)
Hwang, E Shelley, Terry Hyslop, Thomas Lynch, Elizabeth Frank, Donna Pinto, Desiree Basila, Deborah Collyar, et al.. 2019. “The COMET (comparison of Operative Versus Monitoring and Endocrine Therapy) Trial: A Phase III Randomised Controlled Clinical Trial for Low-risk Ductal Carcinoma in Situ (DCIS)”. BMJ Open. BMJ. doi:10.1136/bmjopen-2018-026797.
~418 spots leftby Jul 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top