What carcinoembryonic antigen (CEA) level should trigger further investigation during colorectal cancer follow-up?
| ISRCTN | ISRCTN93652154 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93652154 |
| ClinicalTrials.gov (NCT) | NCT00560365 |
| Protocol serial number | HTA 99/10/99 and HTA 11/136/81 |
| Sponsor | Oxford University (UK) |
| Funder | Health Technology Assessment Programme |
- Submission date
- 27/03/2013
- Registration date
- 29/04/2013
- Last edited
- 16/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof David Mant
Scientific
Scientific
Oxford University Department of Primary Care Health Sciences
Oxford
OX2 6GG
United Kingdom
| Phone | +44 1865 289300 |
|---|---|
| david.mant@phc.ox.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational diagnostic analysis of data collected for an ongoing randomised controlled trial |
| Secondary study design | Other |
| Study type | Participant information sheet |
| Scientific title | What carcinoembryonic antigen (CEA) level should trigger further investigation during colorectal cancer follow-up? - an observational diagnostic data analysis |
| Study acronym | FACS add-on study 2 |
| Study objectives | It is feasible to increase the sensitivity of blood CEA as an indicator of recurrent colorectal cancer while retaining an acceptable level of specificity by specifying a positive result in terms of the change in blood CEA level over time rather than the absolute level of a single measurement. Pilot study on http://www.isrctn.com/ISRCTN61091474 Main trial on http://www.isrctn.com/ISRCTN41458548 |
| Ethics approval(s) | NHS South-West Reserach Ethics Committee, 04/02/2002, ref: MREC/01/6/91 |
| Health condition(s) or problem(s) studied | Colorectal cancer follow-up |
| Intervention | 3-6 monthly blood CEA testing (already completed) |
| Intervention type | Other |
| Primary outcome measure(s) |
The main outcomes (cancer recurrence, treatment of recurrence with curative intent, and death) are monitored continuously. Blood CEA levels are measured 3 monthly for 2 years and 6 monthly for the next 3 years. |
| Key secondary outcome measure(s) |
This add-on analysis examining the diagnostic value of different methods of interpreting blood CEA to detect recurrence will include all outcomes at two time points - 3 years (interim analysis) and 5 years (final analysis) after trial entry. |
| Completion date | 30/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 600 |
| Key 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. |
| Key exclusion criteria | 1. Did not meet inclusion criteria 2. Unable to give written informed consent |
| Date of first enrolment | 01/04/2013 |
| Date of final enrolment | 30/09/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Oxford University Department of Primary Care Health Sciences
Oxford
OX2 6GG
United Kingdom
OX2 6GG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2017 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/06/2017: Publication reference added.
