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Sirolimus for Cowden Syndrome with Colon Polyposis
Study Summary
This trial is investigating the use of sirolimus to reduce the number of colon polyps in patients with Cowden syndrome over a 1 year period.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2008 Phase 4 trial • 293 Patients • NCT00118742Trial Design
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Who is running the clinical trial?
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- I have had colon cancer or a serious type of colon polyp.I have a confirmed PTEN gene mutation.I have Cowden syndrome or a related genetic condition.I have long-term kidney disease.You are pregnant, planning to become pregnant, or planning to father a child within 3 months after treatment.I am able to understand and agree to participate in the study.I am 18 years old or older.I have chronic kidney disease.I have had a colonoscopy showing more than 50 polyps.I have had surgery to remove part or all of my colon.
- Group 1: Treatment arm
- 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
How many participants has this clinical trial enrolled thus far?
"Yes, the records on clinicaltrials.gov indicate that this trial is presently recruiting patients. It was initially posted on September 16th 2019 and amended on November 12th 2021. The research requires 10 participants from a single medical centre."
Does this research encompass individuals aged 65 or greater?
"According to the qualifications for this trial, only patients aged between 18 and 80 can enroll. There are 746 clinical trials available for individuals under the age of majority, while there are 4024 studies open to those above 65 years old."
Are there opportunities to still join this experiment?
"As indicated by clinicaltrials.gov, this research initiative is actively looking for participants; the study was posted on September 16th 2019 and revised most recently on November 12th 2021."
Can you explain the common applications of Sirolimus?
"Sirolimus has a range of therapeutic applications, such as preventing organ transplant rejections and treating kidney diseases like renal angiomyolipomas."
Does this clinical trial have any specific qualifications for participants?
"Applicants for this clinical trial should have been diagnosed with pten hamartoma tumor syndrome and must be of age between 18-80 years. Approximately 10 people are being sought out to complete the study."
Has further research been conducted regarding the effects of Sirolimus?
"Presently, 13 Phase 3 clinical trials are investigating the effects of Sirolimus with a total of 125 active studies. The majority of these research efforts are based in Cincinnati, Ohio; however 1074 other locations have joined their investigation into this medication's efficacy."
Has Sirolimus been given the go-ahead by the Food and Drug Administration?
"Our analysts at Power have assigned sirolimus a score of 2 on their safety scale, since clinical data exists to support its security but efficacy is still unproven."
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