Validity and diagnostic performance of an optimized multi-target stool nucleic acid test combined with FIT (Mainz Biomed Colorectal Cancer Screening Test) for early detection of colorectal cancer and advanced precancerous lesions in colon - COLOFUTURE

Mainz Biomed Germany GmbH0 个研究点目标入组 1,000 人开始时间: 2022年4月27日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Women or men aged 40-85 years who gave their written informed consent and who shall undergo colonoscopy for the purpose of
•Screening colonoscopy for CRC through referral by medical institution, by insurance or by self-referral
•Diagnostic or theraputic colonoscopy through referral by medical institution, by insurance or by self-referral
•Treatment naïve patients who have already been diagnosed with CRC after an initial colonoscopy within the past 3 months and are about to receive their first treatment.

•Contraindications to colonoscopy
•Subject has had a positive DNA based stool test within the previous 2 years
•Subject has a history of CRC or advanced premalignant lesion in colon (Exception: diagnosis of CRC or advanced premalignant lesion by colonoscopy/PAD within the past 3 months which is so far untreated)
•Subject has a diagnosis of diverticulosis/diverticulitis coli
•Subject has a diagnosis or medical/family history of any of the following conditions, including:
•o Familial adenomatous polyposis (also referred to as FAP, including attenuated FAP and Gardner's syndrome)
•o Hereditary non-polyposis CRC syndrome (also referred to as HNPCC or Lynch Syndrome)
•o Other hereditary cancer syndromes including but are not limited to Peutz- Jegers Syndrome, MUTYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis
•Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease
•Subject has a diagnosis of Cronkhite-Canada Syndrome
•Subject has any condition that in the opinion of the investigator should preclude participation in the study
•Subject is unwilling to give informed consent

发起方