Colorectal Surgical Procedure OutcomesCPOPNCT02531789
Procedure Outcome Predictor (POP) Using the Complement Cascade
An observational study of Colorectal Surgical Procedure Outcomes, run by University of Exeter.
Trial summary
Current post-operative monitoring of patient recovery consists measuring two blood markers C-reactive protein (CRP) and White Blood Cell Count (WBC). However, these are slow to respond to the onset of infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgical Procedure Outcomes
- What is being tested?
- Observation
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 45 patients receiving elective colorectal surgery
Who may be able to join
- Elective surgery list of pelvic oncology surgeons
Who cannot join
- Unable/unwilling to provide informed consent
- Pregnant women
- Under 18 years of age
- Pre-existing active infection
- Diabetic
- Inflammatory bowel disorders
Show all 10Show fewer
- Immunosuppressed
- Immunosuppression or steroid treatment within the last 12 months
- Learning disability or mental health problems
- Non-English speakers
About this study
Current post-operative monitoring of patient recovery consists measuring two blood markers C-reactive protein (CRP) and White Blood Cell Count (WBC). However, these are slow to respond to the onset of infection. However, monitoring the absolute levels of the proteins in the three pathways of the complement cascade should provide a faster and better predictor of patient recovery. The investigators propose a pilot trial to measure concentrations of Complement Cascade (CC) activation biomarkers in the blood over a time course around operations of major abdomino-pelvic surgery involving a bowel resection. Further, analysis of the differential CC pathway activation should identify the onset of recovery complications before clinical symptoms present and potentially identify the causes allowing the clinicians to target therapies.
Read the detailed description
The proposed study is a pilot study on a cohort of participants recruited from routine elective colorectal surgery at RD\&E. The pilot trial will collect blood over a time course for a patient to record blood plasma levels of Complement proteins peri-operatively from admission to discharge. The assay schedule is detailed in Table 1 below. The trial will perform additional CC activation tests on routine blood samples taken during the patient's stay in hospital. In addition 4 trial samples will be taken at time intervals that will capture the impulse response of the patient's CC. Sample analysis will be performed in parallel in the clinical chemistry laboratory for laboratory for assays of CRP and the complement proteins C3 and C4. The additional trial assays will be performed on the MSD platform on loan for the period of the trial.
Table 1Blood Sample Assay Schedule Time Point Time of Test Routine Test Additional Trial Test Trial Assays Day Timings 0 t = -1 Pre-admission clinic CONSENT ROUTINE CRP, LFTs, FBC, Amylase, Coag, G\&S C4, C5, IgG C3dg, C4d, Bb, TCC, t =-1 day 2 Pre-operatively t = 0 Under anaesthesia Trial Sample NO.1 C4, C5, IgG C3dg, C4d, Bb, TCC, CRP t = 0 9:30 hrs 3 t =1 hr Under anaesthesia Knife-to-skin plus 30 mins Trial Sample NO.2 C4, C5, IgG C3dg, C4d, Bb, TCC, CRP 10.30 hrs 4 t = 2 - 4 hrs immediately post surgery ROUTINE C4, C5, IgG C3dg, C4d, Bb, TCC, CRP 1330hrs (equivalent to t +4hrs) 5 t = 8 hrs Trial Sample NO. 3 C4, C5, IgG C3dg, C4d, Bb, TCC, CRP 17:30 hrs 6 t = 12 hrs Trial sample NO. 4 C4, C5, IgG C3dg, C4d, Bb, TCC, CRP 21:30 hrs 7 t = 24 hrs ROUTINE C4, C5, IgG C3dg, C4d, Bb, TCC, CRP 09:30 hrs 8 t = 36 hrs ROUTINE C4, C5, IgG C3dg, C4d, Bb, TCC, CRP 21:30 hrs 9 t = 48 hrs
Some Patients Discharged
Complications Develop ROUTINE C4, C5, IgG C3dg, C4d, Bb, TCC, CRP t = x1 Routine Tests as these occur C4, C5, IgG C3dg, C4d, Bb, TCC, CRP t = x2 Routine tests as these occur C4, C5, IgG C3dg, C4d, Bb, TCC, CRP 10 Discharge
The assays deployed for the pilot trial the current biomarkers of C activation panel are C3dg, C4d, Bb, TCC and the acute phase marker, CRP. The TCC assay has been designed in Cardiff (by Prof Morgan a collaborator of Prof Shaw) and the investigators have extensive experience in the design of C protein assays. For the target biomarkers antibodies to neo-antigens that are revealed post enzymatic cleavage or complex formation will be used as capture antibodies on the surface of the MSD platform. The C proteins are then detected with polyclonal antibodies provided by Prof Morgan in Cardiff and labelled with a ruthenium tagged antibody. Whole EDTA-stabilised plasma is then incubated in the 96-well format; all 5 assays, including calibration curves, are run simultaneously. Electroluminescence from the ruthenium complex is collected and quantified automatically. Absolute measurements of C proteins will be performed using standardised fully activated serum which contains a constant amount of activation products from all complement pathways. The serum is available through Prof Morgan's collaboration with the 'Complement Standardization Group'. C activation relative to this standard can then be determined. This work will lead to an array of C activation markers that will be tested against the patient cohort. This array including some of the other pathway markers may ultimately become the basis of a routine clinical test.
- Conditions
- Colorectal Surgical Procedure Outcomes
- Being tested
- Observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
C3, C4, CRP, and the dilution marker total IgG, together with C3dg, TCC and Bb will be measured over a high-sampling frequency time course t=-1 (admission), 0 (induction), 2,4,8,16, 24, 36 and 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Observation | 45 patients receiving elective colorectal surgery Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the Complement Activation with descriptive statistics to establish the size of an effect for a larger prospective cohort study
The study will determine Complement Cascade activation for a cohort of 45 patients receiving elective colorectal surgery. C3, C4, CRP, and the dilution marker total IgG, together with C3dg, TCC and Bb will be measured over a high-sampling frequency time course t=-1 (admission), 0 (induction), 2,4,8,16, 24, 36 and 48 hours.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2015 (estimated)
- Study startNov 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Surgical Procedure OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Devon and Exeter NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Andrew M Shaw, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531789
- Sponsor's protocol ID
- 1011/115491
- Acronym
- CPOP
- Status last verified
- Aug 2015
- First submitted
- 5 Aug 2015
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedure Outcome Predictor (POP) Using the Complement Cascade
- ClinicalTrials.gov ID
- NCT02531789
- Acronym / sponsor ID
- CPOP / 1011/115491
- Conditions
- Colorectal Surgical Procedure Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Royal Devon and Exeter NHS Foundation Trust
- Study start
- Nov 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 24 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current post-operative monitoring of patient recovery consists measuring two blood markers C-reactive protein (CRP) and White Blood Cell Count (WBC). However, these are slow to respond to the onset of infection. However, monitoring the absolute levels of the proteins in the three pathways of the complement cascade should provide a faster and better predictor of patient recovery. The investigators propose a pilot trial to measure concentrations of Complement Cascade (CC) activation biomarkers in the blood over a time course around operations of major abdomino-pelvic surgery involving a bowel resection. Further, analysis of the differential CC pathway activation should identify the onset of recovery complications before clinical symptoms present and potentially identify the causes allowing the clinicians to target therapies.
Detailed description
The proposed study is a pilot study on a cohort of participants recruited from routine elective colorectal surgery at RD\&E. The pilot trial will collect blood over a time course for a patient to record blood plasma levels of Complement proteins peri-operatively from admission to discharge. The assay schedule is detailed in Table 1 below. The trial will perform additional CC activation tests on routine blood samples taken during the patient's stay in hospital. In addition 4 trial samples will be taken at time intervals that will capture the impulse response of the patient's CC. Sample analysis will be performed in parallel in the clinical chemistry laboratory for laboratory for assays of CRP and the complement proteins C3 and C4. The additional trial assays will be performed on the MSD platform on loan for the period of the trial.
Table 1Blood Sample Assay Schedule Time Point Time of Test Routine Test Additional Trial Test Trial Assays Day Timings 0 t = -1 Pre-admission clinic CONSENT ROUTINE CRP, LFTs, FBC, Amylase, Coag, G\&S C4, C5, IgG C3dg, C4d, Bb, TCC, t =-1 day 2 Pre-operatively t = 0 Under anaesthesia Trial Sample NO.1 C4, C5, IgG C3dg, C4d, Bb, TCC, CRP t = 0 9:30 hrs 3 t =1 hr Under anaesthesia Knife-to-skin plus 30 mins Trial Sample NO.2 C4, C5, IgG C3dg, C4d, Bb, TCC, CRP 10.30 hrs 4 t = 2 - 4 hrs immediately post surgery ROUTINE C4, C5, IgG C3dg, C4d, Bb, TCC, CRP 1330hrs (equivalent to t +4hrs) 5 t = 8 hrs Trial Sample NO. 3 C4, C5, IgG C3dg, C4d, Bb, TCC, CRP 17:30 hrs 6 t = 12 hrs Trial sample NO. 4 C4, C5, IgG C3dg, C4d, Bb, TCC, CRP 21:30 hrs 7 t = 24 hrs ROUTINE C4, C5, IgG C3dg, C4d, Bb, TCC, CRP 09:30 hrs 8 t = 36 hrs ROUTINE C4, C5, IgG C3dg, C4d, Bb, TCC, CRP 21:30 hrs 9 t = 48 hrs
Some Patients Discharged
Complications Develop ROUTINE C4, C5, IgG C3dg, C4d, Bb, TCC, CRP t = x1 Routine Tests as these occur C4, C5, IgG C3dg, C4d, Bb, TCC, CRP t = x2 Routine tests as these occur C4, C5, IgG C3dg, C4d, Bb, TCC, CRP 10 Discharge
The assays deployed for the pilot trial the current biomarkers of C activation panel are C3dg, C4d, Bb, TCC and the acute phase marker, CRP. The TCC assay has been designed in Cardiff (by Prof Morgan a collaborator of Prof Shaw) and the investigators have extensive experience in the design of C protein assays. For the target biomarkers antibodies to neo-antigens that are revealed post enzymatic cleavage or complex formation will be used as capture antibodies on the surface of the MSD platform. The C proteins are then detected with polyclonal antibodies provided by Prof Morgan in Cardiff and labelled with a ruthenium tagged antibody. Whole EDTA-stabilised plasma is then incubated in the 96-well format; all 5 assays, including calibration curves, are run simultaneously. Electroluminescence from the ruthenium complex is collected and quantified automatically. Absolute measurements of C proteins will be performed using standardised fully activated serum which contains a constant amount of activation products from all complement pathways. The serum is available through Prof Morgan's collaboration with the 'Complement Standardization Group'. C activation relative to this standard can then be determined. This work will lead to an array of C activation markers that will be tested against the patient cohort. This array including some of the other pathway markers may ultimately become the basis of a routine clinical test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Other: Observation45 patients receiving elective colorectal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 45 patients receiving elective colorectal surgery
Key inclusion criteria (1 listed)
- Elective surgery list of pelvic oncology surgeons
Key exclusion criteria (10 listed)
- Unable/unwilling to provide informed consent
- Pregnant women
- Under 18 years of age
- Pre-existing active infection
- Diabetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationC3, C4, CRP, and the dilution marker total IgG, together with C3dg, TCC and Bb will be measured over a high-sampling frequency time course t=-1 (admission), 0 (induction), 2,4,8,16, 24, 36 and 48 hours. | Other | Observation |
Primary outcome
Assessment of the Complement Activation with descriptive statistics to establish the size of an effect for a larger prospective cohort study
Time frame: 5 days
The study will determine Complement Cascade activation for a cohort of 45 patients receiving elective colorectal surgery. C3, C4, CRP, and the dilution marker total IgG, together with C3dg, TCC and Bb will be measured over a high-sampling frequency time course t=-1 (admission), 0 (induction), 2,4,8,16, 24, 36 and 48 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew M Shaw, PhD principal investigator
University of Exeter
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Surgical Procedure Outcomes, run by University of Exeter.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the Complement Activation with descriptive statistics to establish the size of an effect for a larger prospective cohort study (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2015.