Neoplasms

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alpha-Tocopherol

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tablets composed of 200 mcg selenium \[as l-selenomethionine\], 30 mg zinc, 2 mg vitamin A \[retinol\], 180 mg vitamin C \[ascorbic acid\] and 30 mg vitamin E \[D-α-tocopherol acetate\]

placebo had an identical appearance as intervention

antioxidants

placebo

Luigina A Bonelli, MD

The trial was aimed at evaluating the efficacy of a multiagent antioxidant compound (vitamin A, C, E, selenium and zinc) in reducing the incidence of metachronous adenomas of the large bowel after endoscopic polypectomy. This is a randomized study: a 50% reduction in the incidence of metachronous adenomas was expected in patients allocated to the "active" compound (intervention) arm as compared to those assigned to a placebo.

Adenomatous polyps (or adenoma) are benign lesions of the large bowel that are frequent in people aged 60 or more: about one in four of them has at least one adenoma. In time, adenoma could progress to cancer. Even though only a small rate of adenomas will develop into cancer almost 70-80% of colorectal cancer origin from an adenoma and colorectal cancer is one of the most frequent malignant tumors in the western world. Several epidemiological studies showed that subjects who had low intake and/or low blood levels of selenium were at increased risk of developing colorectal cancer.

Antioxidant Supplement and Reduction of Metachronous Adenomas of the Large Bowel: a Double Blind Randomized Trial

Evaluation of the Efficacy of a Combination of Micronutrients (Vitamin A, C, E, Selenium and Zinc) in Reducing the Incidence of Colorectal Metachronous Adenomas. A Double Blind, Phase III, Randomized, Placebo-controlled Trial

LILT (Italian league against cancer)

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

MD, responsible of the unit of secondary prevention and screening

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients who suffered metachronous adenoma after proximal colorectum cancer surgery.

Patients who do not suffere metachronous adenoma after proximal colorectum cancer surgery.

Patients who suffered metachronous adenoma after distal colorectum cancer surgery.

Patients who do not suffered metachronous adenoma after distal colorectum cancer surgery.

Yunwei Wei

Ye Jin

Patients with colorectal cancer are known to be at high risk of developing metachronous adenoma, however, participation in colonoscopy are low. Colonoscopy, the primary modality used all over the word, is costly and invasive, and its efficacy depends on the endoscopist's skill and the patient's bowel preparation. As life expectancy of patients with history of colon cancer is increasing, colonoscopy would increase the overall cost for patients and for the health care system. This study aim to construct a predictive model of postoperative colorectal neoplasm development using microbiota analysis.

Colorectal cancer(CRC) is one of the most common malignancies in China and in Western countries. Furthermore, those with a history of CRC are at a higher risk for developing metachronous adenomas or CRC recurrence during the followup period. It has been reported that 0.7% of patients develop metachronous CRC during the 3 years after surgical resection for the initial CRC.

Surveillance colonoscopy is highly recommended by major international scientific societies with the intent of either detecting anastomotic recurrence at an early, curable stage or identifying metachronous premalignant(ie, adenomas) and malignant lesions. As life expectancy of patients with history of colon cancer is increasing, the costly and invasive postoperative examination increased the overall cost and suffering for patients.

The human colon plays host to a diverse and metabolically complex community of microorganisms. While colonic microbiome development along the colorectal adenoma-carcinoma sequence. Investigators speculate that gut microbiota related to metachronous adenoma or CRC, after curative treatment.

This study aim to discover if any difference of gut microbiota exist in patients who suffer from metachronous adenomas compared with patients who do not. Further try to seek the divergence microbiota of metachronous adenomas between Proximal and Distal Colorectum. construct a predictive model of postoperative colorectal neoplasm development using microbiota analysis. Finally, using microbita construct a predictive model of postoperative colorectal neoplasm development.

Gut Microbiota Prediction of Metachronous Colorectal Neoplasms

Gut Microbiota Prediction of Metachronous Colorectal Neoplasms in Patients With Colorectal Cancer

The diversity, structure of microbiota and relative abundance of special bacterial taxa 16S rRNA gene sequencing will be performed.

Using microbita construct a predictive model of postoperative colorectal neoplasm development.

Validation the accuracy of the predictive model.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Antioxidant Supplement and Reduction of Metachronous Adenomas of the Large Bowel: a Double Blind Randomized Trial	NCT01437826	Colorectal Aden...	antioxidants placebo	25 Years - 75 Years	IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Gut Microbiota Prediction of Metachronous Colorectal Neoplasms	NCT03383159	Gut Microbiota Metachronous Ad...		35 Years - 75 Years	First Affiliated Hospital of Harbin Medical University

Spots Global Cancer Trial Database for metachronous adenoma