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Familial Adenomatous Polyposis (FAP) Research: Children/ Teens

What is the purpose of this study?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical study or trial, to test the effect and safety of the study drug celecoxib for the treatment of familial adenomatous polyposis (FAP) in children and teens. The study will help determine if the study drug can stablilize or reduce the size of adenomatous (glandular) polyps (growths) and maintain the size of polyps to a level that would delay or even prevent a colectomy (removal of part of the colon). Celecoxib has been approved for use in adults.

Who can participate?

Children and teenagers 10 to 17 years old who have the gene mutations for FAP may be eligible to participate.

Ages

From 10 To 17 years old

Conditions

Gastroenterology, Hepatology and Nutrition
Medications
Other

What is involved?

The study includes 8 to 10 visits over approximately 5 years and involves the following procedures:

Screening:
Your child will:

Have a complete physical exam including vital signs (height, weight, blood pressure, etc.)
Have blood test
Submit a urine sample
Have a electrocardiogram(ECG)to measure the electrical activity of the heart
Have a colonoscopy (an examination of the colon and the large bowel with a camera inserted with a probe) under the effect of anesthesia (used to put him/her to sleep)

Screening Eligibility:

Performing the colonoscopy will allow the study doctor to see the inside of the large bowel with the probe and count and measure the number of polyps to determine if your child is eligible for the study
If the study doctor cannot remove all of the polyps or counts 20 polyps or more, your child will not be able to participate in this study

Study Procedures:

Your child will:

Be randomized (assigned by chance) to either receive the study drug celecoxib or placebo (no active drug)
Instructed about when and how to take the study drug or placebo
Be asked to fill out a study diary to track doses and symptoms
Submit a blood sample
Be asked over the phone about he/she is doing, about any symptoms and any new medications
Come back in for visits at 6 months, 12 months, and then each year thereafter for 5 years with some of the procedures including:

Physical exam, including vital signs
Blood and urine samples
Colonoscopy
Will be asked questions about side effects and new medications

You will (as the parent):

Be asked to submit a blood sample to confirm a positive genetic mutation
Be contacted by a member of the research staff to check in on how your child is doing, about any symptoms he/she is experiencing and any new medications
Be asked to bring your child in for 8 to 10 visits at Cincinnati Children’s Hospital Medical Center

What are the benefits?

Your child may or may not receive a direct benefit from participating in this study. He/she may have a positive response to the study drug if randomized to receive it. Also, the information learned from this study may benefit other patients with FAP in the future.

Will I get all the facts about the study?

If you are interested in having your child participate, you will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until you have signed this form and, if of age, your child has given at minimum his/her verbal agreement.

Do participants receive pay, compensation or reimbursement?

Families will receive up to $700 (if all visits are completed) for study time and travel. If you travel more than 50 miles for visits, you will be reimbursed for out-of-pocket expenses such as mileage and meals up to a certain amount.