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Surgery vs Active Monitoring for Low-Risk Ductal Carcinoma In Situ (COMET Trial)
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.
COMET Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOMET Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.COMET Trial Design
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Who is running the clinical trial?
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- I am medically cleared for surgery.I have been diagnosed with a type of non-invasive breast cancer.I have been diagnosed with a type of non-invasive breast cancer or precancerous condition.I haven't had breast cancer or similar conditions in the same breast within the last 5 years.I am fully active or can carry out light work.I was 40 years or older when diagnosed with DCIS.I had surgery for breast cancer with some cancer cells found at the edge of the removed tissue.I have colored or bloody discharge from the nipple on one side.I haven't had breast cancer or DCIS in the same breast within the last 5 years.I have taken tamoxifen, an aromatase inhibitor, or raloxifene in the last 6 months.I had a lump found by exam or imaging before being diagnosed with DCIS.I am medically cleared for surgery.I am fully active or can carry out light work.I can read and speak either Spanish or English.I am currently taking hormone medications.I am a male diagnosed with DCIS (a type of breast cancer).My condition is Grade III DCIS.My recent mammogram showed a suspicious area in my breast not yet checked by a biopsy.I have been diagnosed with invasive or microinvasive breast cancer.
- Group 1: Surgery
- Group 2: Active Monitoring
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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