OnCoRe Plus Research Database

• Research type

  Research Database

• IRAS ID

  318679

• Research summary

  Rectal Cancer Oncological Complete Response Database (OnCoRe Plus)

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  22/WM/0206

• Date of REC Opinion

  24 Oct 2022

• REC opinion

  Favourable Opinion

• Data collection arrangements

  Some patients have a complete disappearance of their rectal cancer after chemoradiotherapy. Rather than receiving surgery, these patients are kept under close observation – known as “watch and wait”. Initially, this was not standard practice and there was uncertainty around whether these patients were at more risk than those who have standard surgical treatment.

  In 2017, we set up the OnCoRe Research Database to collect demographic, treatment, diagnosis and outcome data for these patients, along with a comparator group who received standard treatment. We would like to continue this data collection to further understand the long term outcomes of these patients in order for this treatment option to be offered as standard practice in the UK.

  Patients will be identified and approached by a member of their clinical team after they have been confirmed to have a complete response. They will be fully informed about the use of their data for research purposes and provide written consent if happy to proceed. The only identifiable data that will be stored is their NHS number, which will be kept separate from the clinical information within the database, in a password protected file on a secure server within The Christie NHS Foundation Trust.

• Research programme

  This database will continue to collect data on the safety of the ‘watch and wait’ policy (with surgery data only if the tumour relapsed), rather than proceeding directly to radical surgery in patients with an apparently complete response to radiotherapy. This database is the largest database of its kind for this group of patients in the UK and one of the largest in the world. This means it is an invaluable tool for future research on a crucial patient group who are undergoing a relatively new treatment pathway. Work done to date has resulted in numerous key publications that has provided some initial evidence that patients who have a complete response and chose to avoid surgery may not be at a disadvantage. There is still some uncertainty around this treatment and further work is needed for this to be safely incorporated standard practice. By continuing this work, we will ensure patients who have the choice between watch and wait and surgery are able to be fully informed when making this decision, meaning they receive the treatment that not only provides the best chance of living free from cancer, but also ensures they have the best possible quality of life.

• Research database title

  Rectal Cancer Oncological Complete Response Database (OnCoRe Plus)

• Establishment organisation

  The Christie NHS Foundation Trust

• Establishment organisation address

  Wilmslow Road

  Manchester

  M20 4BX