T-FRAG

Collection and storage of tumour and blood samples from participants with lung cancer in the FRAGMATIC trial.

The T-FRAG study was a separately funded and REC approved study that ran in parallel to an associated clinical trial; FRAGMATIC: A randomised phase III clinical trial investigating the effect of FRAGmin added to standard therapy in patients with lung cancer. FRAGMATIC was the largest UK multi-centre trial of lung cancer patients with low molecular weight heparin.

T-FRAG was developed in collaboration with the National Cancer Research Institute (NCRI) Lung Clinical Studies Group, NCRI Translational Clinical Studies Group, and the Wales Cancer Trials Unit (WCTU) Translational Working Group.

T-FRAG aimed to collect a high quality set of samples from consenting FRAGMATIC participants for future use by research groups with specific interests in translational research and cancer:

1. Tissue samples in the form of paraffin blocks in the subgroup of patients who received surgery as their anticancer (expected to be approximately 15% - a total of 330 patients).
2. Blood samples at baseline and again at week 24 (at the end of FRAGMATIC protocol treatment) for all patients, i.e. 2 blood samples per patient giving an expected total of 4400 samples.

Results

Sample collection is complete and the study is closed. A total of 36 centres across the UK were opened to recruitment and actively collecting samples. The following samples were collected:

• 395 blood samples including pre- and post-treatment samples;
• 105 complete sets of blood samples were collected, i.e. pre- and post-treatment samples from the same patient therefore same genetic background;
• 16 paraffin embedded biopsy samples from patients who underwent surgery as part of their standard care.

All samples were of good quality for future DNA and protein analysis. However, the number of samples collected was significantly lower than expected. This was predominantly due to not all FRAGMATIC sites agreeing to run T-FRAG, a lower than anticipated sample return rate due to FRAGMATIC participants being able to opt out of participation in T-FRAG, and the extra resources required to run the study due to the study being funded and REC approved in isolation from the main  study, FRAGMATIC.

The samples have been stored at the Wales Cancer Bank (WCB) for release to researchers. The WCTU have utilised the blood samples collected and performed protein analysis which included looking at expression levels of various biomarkers of thrombosis, angionesis and metastasis. Data analysis is currently in progress.

Researchers with an interest in using the samples in future research should submit an initial request to the general enquiries contact for the study. Priority will be given to those investigating the response to heparin and research that relates directly to lung cancer. Researchers may investigate a host of prognostic and predictive hypotheses contained within separate proposals.