Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2025-12-24 @ 10:18 PM
NCT ID:
NCT00503035
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of familial adenomatous polyposis (patients should have colorectal remnant that can be biopsied. Patients who have had total colorectal surgical resection are not eligible).
2. Adequate bone marrow function (ANC \> 1500 ml, platelet count \> 100,000/ml). Serum creatinine, total bilirubin, and ALT \< 1.5 upper limit normal.
3. Over 16 years of age.
4. Patient is able to give an informed consent.
5. Women of childbearing potential (women are considered to be of childbearing potential unless they are at 2 or more years post-menopausal/or surgically sterile), must:
* Not be pregnant or lactating.
* use adequate contraceptive measures (abstinence, IUD, birth control pills, or diaphragm or condom with spermicidal gel) starting with last menses and throughout the study duration.
* Have a negative serum pregnancy test within 14 days of starting celecoxib.
Exclusion Criteria:
1. Inflammatory bowel disease.
2. Intake of anti-inflammatory medications (e.g., non-steroidal, aspirin, and sulfasalazine) that cannot be discontinued starting 3 days prior to the enrollment.
3. Chemotherapy or radiation therapy in less than three months from the time of enrollment.
4. Individuals who are taking Coumadin that can not be discontinued starting 7 days prior to the enrollment.
5. Individuals who have received an investigational chemopreventive agent during the month prior to the biopsies.
6. History of bleeding diathesis.
7. History of sulfonamides (sulfa) allergies.
8. History of cardiovascular diseases that might include the following: myocardial infarction, angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery.
9. Uncontrolled hypertension (\> 135/\> 85 mm Hg on three repeated measurements during the 6 weeks prior to enrollment on the study).
10. Diagnosis of diabetes.
11. Smoking history during the 6 months prior to enrollment on the study.
12. Uncontrolled hypercholesteremia (low-density lipoprotein cholesterol (LDL-C) \> 130). Hypercholesteremia needs to be controlled following the updated the National Cholesterol Education Program Adult Treatment Panel III Guidelines for at least 3 months prior to enrollment on the study. Hypercholesteremia treatment needs to be continued during the enrollment on the protocol.
13. Family history of premature coronary disease (i.e., onset \< 55 years of age).
14. Metabolic syndrome diagnosis in patients who are 30 years or older. (The diagnosis of metabolic syndrome is made when three or more of these risk factors are present):
* Waist circumference: Men \> 102 cm (\> 40 in); Women \> 88 cm (\> 35 in). \*Triglycerides = 150 mg/dl (= 1.69 mmol/L).
* High-density lipoprotein cholesterol (HDL-C): \[Men \< 40 mg/dl (\< 1.03 mmol/L), Women \<50 mg/dl (\< 1.29 mmol/L)\].
* Blood pressure = 130/= 85 mm Hg.
* Fasting glucose = 110 mg/dl (= 6.1 mmol/L).
15. History of deep venous thrombosis, pulmonary embolism, systemic lupus erythematous, family history of protein S or C deficiencies or prior heparin-induced thrombocytopenia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00503035
Study Brief:
Protocol Section:
NCT00503035