You are invited to take part in a research project. You do not have to take part in this study if you do not want to. If you do decide to take part you may withdraw at any time without having to give any reason. Your decision wtiether to take part or not will not affect your care and management in any way. A ll proposals for research using human subjects are reviewed by an ethics committee before they can proceed. This proposal was reviewed by the joint UCL/UCLH Committees on Ethics o f Human Research.
1. This study aims to establish if PET scans are better than conventional methods, such as computerised tomography (CT^ scans and measurement o f carcinoembryonic antigen (CEA) in the blood, at detecting recurrence o f cancer o f the large bowel. CEA is a substance found in the blood and which may be elevated when bowel cancer is present.
2. After operative treatment for large bowel cancer some patients develop recurrent cancer. If this is detected early further surgery, chemotherapy or radiotherapy may result in an improved chance o f cure. It is routine practice to perform CT scans (every 6 months) and blood tests for CEA (every 3 months) following operative treatment o f bowel cancer in order to detect and treat these patients Wio may develop a recurrence. If an abnormality is detected in a CT scan or the CEA is elevated then patients are offered a series o f tests in order to confirm the diagnosis and start appropriate treatment. These tests may involve further scans or a biopsy if there is any doubt.
3. PET scanners detect radioactive substances. A small amount o f radioactive glucose, which is so small as to be safe for the purpose o f diagnostic testing, is injected into one o f your veins. If recurrent cancer is present the glucose injected is concentrated here. The PET scanner will therefore detect recurrent cancer by detecting areas o f high concentration o f radioactive glucose. In this study you will have a PET scan every 6 months for 2 years. If an abnormality is detected you may require further scans or possibly a biopsy i f there is any doubt.
Description of Research Study
Patients who have been treated for cancer o f the large bowel will be followed up in the surgical outpatient department in the normal way. This will involve CT scans every six months and blood tests for CEA every three months ( abnormal results will trigger investigation for recurrent cancer). Those patients taking part in the research study will also have a PET scan as an outpatient every six months for a two year period. If abnormalities are found on PET scans then investigation for recurrence will be initiated as routinely with the other two tests. In some cases biopsies are necessary to confirm or refute the diagnosis o f recurrence. If biopsies are taken they w ill be analysed (as is routine practice) for recurrence. In addition a fi-agment o f tissue will be examined for receptors to cancer growth factors. At the end o f the study PET and CT w ill be compared to see if PET is better, the same as or worse than CT for detecting recurrence and whether this diagnosis can be made with more certainty. These results w ill be then compared to the pathological findings and endothelin receptor status in those patients who undergo a biopsy. The ultimate aim is to devise a way o f detecting recurrence early and possibly developing a marker in the tissue which indicates the risk o f recurrence from a particular individual cancer. This information w ill allow appropriate and early treatment o f recurrence with better information on eventual outcome.
CONFIDENTIAL
CONSENT FORM
STUDY TITLE: The role of Positron Emission Tomography (PET) in the follow up of patients with a history o f colorectal cancer
PATIENT NAME: HOSPITAL NUMBER: WARD/ ADDRESS:
By signing this form I agree that:
6. I have read the patients information sheet and the procedure has been fully explained to me. 7. I have had the opportunity to ask questions and I did receive satisfactory answers.
8. I have been given a copy o f the information sheet and the consent form to keep.
9. I understand that I am participating in a research study and I understand the risks and benefits involved. 1 freely give my consent to participate in the research study outlined in the patient information sheet.
10. I understand that 1 may withdraw from this research study at any time without giving a reason for withdrawing and such a decision would not affect the standard o f care that 1 receive in any way.
Signature o f participant... Date.
Name o f participant (Block Capitals). Investigator Statement
I have carefully explained to the above named patient the nature o f the research protocol. I hereby certify that to the best o f my knowledge the subject signing this form understands the nature, demands, risks and benefits involved in participating in this study.
Signature o f investigator. Capitals)... Date. Signature o f witness. Capitals)... Date.
Name o f investigator (Block
... Name o f witness (Block
Principal Investigator: Professor I. Taylor (tel: 0207-504-9312)