What carcinoembryonic antigen (CEA) level should trigger further investigation during colorectal cancer follow-up?

Not Applicable

Completed

• Conditions: Colorectal cancer follow-up; Cancer; Colorectal

• Registration Number: ISRCTN93652154
• Lead Sponsor: Oxford University (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-29
• Last Update Posted: 24 July 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Diagnosis of primary colorectal cancer. Stage I-III disease
2. Have undergone curative resection (i.e., no residual disease [R0]). Microscopically clear margins
3. Complete normal colonic imaging pre-operatively (or post-operatively if unable to view complete colon pre-operatively) by colonoscopy, barium enema, CT pneumocolon, or virtual colonoscopy
4. Post-operative blood CEA = 10 ng/mL (if the normal range is = 5 ng/mL) OR < 2 times upper limit of normal (if normal range is > 5 ng/mL). For patients undergoing adjuvant therapy, CEA should be measured after completion of chemotherapy
5. Has completed primary curative treatment, as deemed by hospital clinician. Patients awaiting stoma closure allowed
6. No evidence of metastatic disease on pre- or post-operative liver CT scan (or ultrasound) and chest CT scan (or chest x-ray)
7. No diagnosis of familial adenomatous polyposis (FAP) or dominantly inherited colon cancer
8. No concurrent serious illness
9. History of other carcinoma allowed provided primary treatment has been completed, there is no evidence of recurrent disease, and there is no follow-up that conflicts with study follow-up
10. Pre-operative radiotherapy or chemoradiotherapy for rectal cancer allowed provided curative resection has been achieved
11. No concurrent participation in a primary treatment clinical trial with conflicting follow-up requirements
12. Participation in the FACS trial in one of the two arms being followed-up with regular scheduled blood CEA tests.

Exclusion Criteria

1. Did not meet inclusion criteria
2. Unable to give written informed consent

Study & Design

• Study Type: Observational
• Study Design: Not specified