Collagenase Biobank Study

Официальное название

Collagenase Producing Bacteria as a Biomarker and Driver of Diet-induce Colorectal Cancer Recurrence and Metastasis Following Surgery

Обзор

The purpose of this study is to look at how bacteria present within the stool at the time of surgery and postoperatively may contribute to the development of cancer recurrence after surgery. By collecting stool and blood before and after surgery, the researchers hope to determine if certain types of bacteria, or products that the bacteria produce, promote the development of tumors after surgery. By collecting tumor tissue and growing cell lines, we hope this will help researchers better understand the behavior of these types of tumors.

Подробное описание

The purpose of this study is to collect stool, blood, and tissue samples both before and after patients undergo surgery for colon cancer. These samples will be analyzed for their bacterial composition and function, and assayed for bacterial-derived metabolites. Additionally, these samples will be tested in the laboratory for their ability to promote tumor formation in cancer cells and in animal models of surgery. Finally, patients will undergo nutritional surveys to document their current nutritional intake. Integration of the patient's nutritional intake with the data from the analyzed biospecimens will allow the researchers to determine if these bacteria and/or their metabolites are more prevalent in patients who eat certain diets. Taken together, results from this study will provide knowledge as to the mechanisms by which tumors form after surgery and potentially allow for future therapies to prevent it.

Первичные конечные точки

• Collagenase Activity [Срок оценки: From Enrollment to 12 months postoperative.]

Вторичные конечные точки (3)

• Stool Metagenomics [Срок оценки: From Enrollment to 12 months postoperative.]
• Stool metabolomics [Срок оценки: From Enrollment to 12 months postoperative.]
• Serum Metabolomics [Срок оценки: From Enrollment to 12 months postoperative]

Критерии участия

Критерии включения

• English speaking.
• All genders, races, and ethnicities.
• Aged greater or equal to 18 years of age.
• Ability to understand and the willingness to sign a written informed consent form.
• Diagnosed with a colon adenocarcinoma or presumed adenocarcinoma in which surgical resection is recommended.
• Have a planned surgical resection of the colon adenocarcinoma at the University of Chicago Comprehensive Cancer Center.
• Reside within 150 miles of the University of Chicago Comprehensive Cancer Center.

Критерии исключения

• Stage IV colon adenocarcinoma (known metastatic disease).
• Intravenous or oral antibiotic exposure within 30 days of surgery to treat an infection.
• Prebiotic exposure within 30 days of surgery.
• History of neoadjuvant chemotherapy/radiation to treat the primary colon adenocarcinoma.
• History of chemotherapy/radiation to treat a separate malignancy within the last 6 months.
• History or current ileostomy or colostomy.
• Allergy to perioperative medications (oral neomycin/metronidazole for preoperative bowel preparation, intraoperative prophylactic intravenous cefoxitin).
• Patients who are pregnant.
• Patients with a history of inflammatory bowel disease.
• Patients with a history of bariatric surgery.
• History of eating disorders.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• University of Chicago — Chicago

Идентификаторы

NCT: NCT07211230 · IRB25-0833

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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