Condition category
Cancer
Date applied
27/03/2013
Date assigned
29/04/2013
Last edited
06/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Mant

ORCID ID

Contact details

Oxford University Department of Primary Care Health Sciences
Oxford
OX2 6GG
United Kingdom
+44 1865 289300
david.mant@phc.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00560365

Protocol/serial number

HTA protocol numbers 99/10/99 and 11/136/81

Study information

Scientific title

What carcinoembryonic antigen (CEA) level should trigger further investigation during colorectal cancer follow-up? - an observational diagnostic data analysis

Acronym

FACS add-on study 2

Study hypothesis

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

NHS South-West Reserach Ethics Committee, 04/02/2002, ref: MREC/01/6/91

Study design

Observational diagnostic analysis of data collected for an ongoing randomised controlled trial

Primary study design

Observational

Secondary study design

Other

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colorectal cancer follow-up

Intervention

3-6 monthly blood CEA testing (already completed)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/04/2013

Overall trial end date

30/09/2013

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

The 600 participants have already beeen recruited and 6000 blood test results are available for analysis analysis

Participant exclusion criteria

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

Recruitment start date

01/04/2013

Recruitment end date

30/09/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford University Department of Primary Care Health Sciences
Oxford
OX2 6GG
United Kingdom

Sponsor information

Organisation

Oxford University (UK)

Sponsor details

Radcliffe Observatory Quarter
Oxford
OX2 6GG
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

UK NIHR HTA programme (protocol 99/10/99)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

06/09/2016: No publications found in PubMed, verifying study status with principal investigator.