Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas

Prior treatment

• Cancer patients who have had any surgery, radiation, or chemotherapy for their current colorectal cancer prior to collecting the baseline samples
• Other active malignancy within 3 years of enrollment except any of the following:
  • Squamous cell carcinoma of the skin
  • Basal cell carcinoma of the skin
  • Carcinoma in situ of the cervix, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery only. (Excluded if had pelvic radiation)
  • Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery
• Patients on active chemotherapy or radiation treatment for any purpose

Other illness

• History of or clinically active Inflammatory Bowel Disease
• Known HIV or chronic active viral hepatitis

Other

• Known HNPCC or FAP
• Inability to provide informed consent.
• Women who are pregnant
• CT colonography (virtual colonoscopy) patients

• Willing to sign informed consent
• Able to physically tolerate removal of up to 60 ml of blood
• Adults at least 18 years old
• Willing to collect 1-2 stool samples and prepare a Fecal Immunochemical Test (FIT)
• Pregnant or nursing women who otherwise meet the eligibility criteria may participate
• Subjects with one of the following:
  • Colorectal adenocarcinoma-not treated and in colon at time of stool collection (CRC bin)
  • Adenoma-pathologically confirmed adenoma present in colon at time of stool collection (Adenoma Bin)
  • Higher Risk Non-neoplastic Bin
  • Subjects with a personal history of adenomas (confirmed by pathology) with none present on qualifying colonoscopy
  • Subjects with a personal history of CRC (longer than 3 years ago because of exclusion criteria of cancer within last 3 years) with none present at time of qualifying colonoscopy
  • Any family history of CRC (1st degree relative)
  • Current positive screening stool test for blood, for DNA or for both within 12 months with no follow-up intervention.
  • Average Risk, Non-neoplastic Bin
  • No history or current finding of any colorectal neoplasia including CRC, adenomas, sessile serrated adenomas and no family history of CRC.
  • Subjects who had CRC that was successfully treated at least three years ago may be considered eligible for the adenoma bin if their polyps are adenomas and there is no evidence of CRC, or for the higher risk non-neoplastic bin as noted above.
  • Subjects whose screening colonoscopy shows any of these types of polyps may be included in the non-neoplastic or the higher risk non-neoplastic bin if they meet the other criteria noted above.
  • Hyperplastic polyps
  • Benign mucosal polyps
  • Polypoid granulation tissue
  • Prolapsed mucosal polyps
  • Inflammatory polyp
  • Transitional mucosal polyp
  • Lipoma
  • Gangleoneuroma
  • Neuroma
  • Hamartomatous polyp