NHS Digital Data Release Register - reformatted

Cardiff University School Of Medicine projects

21 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).


MR1239 - SCOPE 1: Study of Chemotherapy in Oesophageal cancer Plus or minus Erbitux — DARS-NIC-147887-RJFZH

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable, Anonymised - ICO Code Compliant (, , Consent (Reasonable Expectation))

Legal basis: , Informed Patient consent to permit the receipt, processing and release of data by NHS Digital, Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Academic)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2011-07-11 — 2021-07-10

Access method: One-Off

Data-controller type: CARDIFF UNIVERSITY

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Flagging Current Status Report
  4. MRIS - Members and Postings Report
  5. MRIS - Personal Demographics Service

Objectives:

SCOPE 1 is a study in patients with cancer of the oesophagus for whom it has been decided the best form of treatment is chemo-radiation (treatment that involves giving radiotherapy together [or concurrently] with chemotherapy). The trial aims to identify whether the addition of the monoclonal antibody cetuximab (Erbitux™) to definitive chemo-radiation (CRT) shows evidence of enhanced overall survival, whether it is safe, and whether the treatment of patients with non-metastatic carcinoma of the oesophagus is feasible. If cetuximab is found to be active, safe and feasible then the trial will continue recruitment to accrue sufficient patients to establish whether the addition of cetuximab to the standard treatment improves overall survival.