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Surgery vs Active Monitoring for Low-Risk Ductal Carcinoma In Situ (COMET Trial)

N/A
Waitlist Available
Led By Shelley Hwang, MD, MPH
Research Sponsored by Alliance Foundation Trials, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of unilateral, bilateral, unifocal, multifocal, or multicentric DCIS without invasive breast cancer, atypia verging on DCIS, or DCIS + LCIS
Patient who has had a lumpectomy or partial mastectomy with margins positive for DCIS as part of their treatment for a current DCIS diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2, 5, and 7 year follow-up
Awards & highlights

COMET Trial 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.

Who is the study for?
This trial is for women aged 40 or older diagnosed with low-risk DCIS (a type of breast condition) who haven't had previous breast cancer in the same breast within 5 years. Participants should be able to undergo surgery if needed, have a good performance status, and agree to regular follow-ups. Pregnant women, those with certain serious conditions, or prior use of specific hormone treatments are excluded.Check my eligibility
What is being tested?
The COMET Trial is comparing active monitoring versus surgery for managing low-risk Ductal Carcinoma In Situ (DCIS). The study aims to determine whether active monitoring leads to similar cancer outcomes and quality of life as compared to surgical intervention.See study design
What are the potential side effects?
Potential side effects from the interventions in this trial could include typical risks associated with surgeries such as infection, bleeding, pain at the incision site, and possible complications from anesthesia. Active monitoring itself does not involve direct side effects but may carry risks related to delayed treatment.

COMET Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a type of non-invasive breast cancer.
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I had surgery for breast cancer with some cancer cells found at the edge of the removed tissue.
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I was 40 years or older when diagnosed with DCIS.
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I haven't had breast cancer or DCIS in the same breast within the last 5 years.
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I am medically cleared for surgery.
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I am fully active or can carry out light work.

COMET Trial 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

COMET 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 Location

Who is running the clinical trial?

Alliance Foundation Trials, LLC.Lead Sponsor
23 Previous Clinical Trials
24,035 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
548 Previous Clinical Trials
29,995,590 Total Patients Enrolled
Duke UniversityOTHER
2,351 Previous Clinical Trials
3,408,549 Total Patients Enrolled

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
~374 spots leftby Jul 2028