LORIS Trial: For Investigators

If there is a change of staff working on the trial please print off and complete the relevant registration form below. Please also ensure that the Signature and Delegation Log is updated. Return both documents to the LORIS Trial Office.

• Investigator Registration Form [.pdf]
• Site Staff Registration Form [.pdf]
• Lead Pathologist Registration Form [.pdf]
• Lead Radiologist Registration Form [.pdf]

Links to the current protocol, Patient Information Sheet, Informed Consent Form are provided below. If there has been a recent amendment to the trial please ensure you have R&D approval before using these documents.

Other documents (e.g. Amendments, Case Report Form, Serious Adverse Event Form, Guidelines, GP Letter, Release of Medical Information Form etc) can be found by clicking on the other menu items below. If you cannot find what you are looking for please contact the LORIS Trial Office.

• Protocol [.pdf]
• Patient Information Leaflet [.pdf]
• Patient Information Sheet A [.pdf]
• Patient Information Sheet B [.pdf]
• Patient Information Sheet C [.pdf]
• Informed Consent Form A [.pdf]
• Informed Consent Form B [.pdf]
• Informed Consent Form C [.pdf]
• GP Letter  [.pdf]

Version Control Lists

The version numbers and dates of all documents used for the trial are captured on a Document Version Control List. Links to the Document Version Control Lists used in this trial are below in reverse date order.

• Version Control Log - Investigator Site File [.pdf]
• Version Control Log - Pathology Manual [.pdf]

Amendments

Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.

• Amendment 1.0, November 2014 [opens new page]
• Amendment 2.0, July 2015 [opens new page]
• Amendment 3.0, March 2016 [opens new page]

Case Report Form

• Additional Treatment Form [.pdf]
• Annual Follow Up Form [.pdf]
• Baseline Form [.pdf]
• Central Histopathology Review Request Form (Study Eligibility) [.pdf]
• Central Histopathology Review Request Form (Grade Migration/New Disease) [.pdf]
• Death Form [.pdf]
• Deviation Form [.pdf]
• Eligibility Checklist [.pdf]
• Invasive Breast Cancer Form [.pdf]
• New Non Breast Cancer or Metastatic Form [.pdf]
• Radiology 2nd Opinion Review Request Form [.pdf]
• Randomisation Form [.pdf]
• Registration Form [.pdf]
• Surgery Form [.pdf]
• Translational Tissue Sample Collection Form [.pdf]
• Withdrawal of Consent Form [.pdf]

Guidelines

• CRF Completion Guidelines [.pdf]
• SAE Form Completion Guidelines [.pdf]

Other Trial Documents

• Pathology and Sample Collection Guidelines [.pdf]
•  

1)    Rea D, Francis A: Breast screening saves lives: now is the time to address overtreatment, J Comp Eff Res 2014, 3:111-113

2)    Fallowfield L, Matthews L, Francis A, Jenkins V, Rea D. Low grade Ductal Carcinoma in situ (DCIS): How best to describe it? Breast. 2014;23(5):693-6. Epub 2014/07/06.

3)    Francis A, Bartlett JMS, Billingham LJ, Bowden SJ, Brookes CL, Dodwell DJ, Evans AZ, Fallowfield LJ, Gaunt CH, Hanby AM, Jenkins VA, Pinder S, Reed MW, Roberts T, Thomas JS, Wallis MG, Wilcox MH, Rea DW.The LORIS trial: A multicentre, randomized phase III trial of standard surgery versus active monitoring in women with newly diagnosed low risk ductal carcinoma in situ, Cancer Res 2013;73(24 Suppl): Abstract nr OT2-3-01.

4)    Soumian S, Verghese ET, Booth M, Sharma N, Chaudhri S, Bradley S, et al. Concordance between vacuum assisted biopsy and postoperative histology: implications for the proposed Low Risk DCIS Trial (LORIS). European journal of surgical oncology: the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology. 2013;39(12):1337-40. Epub 2013/11/12.

5)    Fallowfield L, Francis A, Catt S, Mackenzie M, Jenkins V: Time for a low-risk DCIS trial: harnessing public and patient involvement, Lancet Oncol 2012, 13:1183-1185

Newsletters

• Newsletter - Sep 2016 [pdf.]
• Newsletter - July 2016 [.pdf]
• Newsletter - May 2016 [pdf.]
• Newsletter - March 2016 [pdf.]
• Newsletter - February 2016 [.pdf]
• Newsletter - December 2015 [.pdf]
• Newsletter - October 2015 [.pdf]
• Newsletter - February 2015 [.pdf]
• Newsletter - April 2014 [.pdf]

Chief Investigator

Dr Matthew Wallis, Cambridge Breast Unit, Addenbrooke’s Hospital, Cambridge, CB2 2QQ, UK

Tel: +44 (0)1223 586 578

LORIS Trial Office

Trial Coordinator:  Miss Jennie Young
Trial Monitor:         Miss Saika Kauser
Trial Management Team Leader:  Miss Claire Gaunt
Trial Statistician:    Miss Sarah Pirrie

Cancer Research UK Clinical Trials Unit (CRCTU)
School of Cancer Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT

Enquiries

Telephone: +44 (0)121 414 3017 
Fax: +44 (0)121 414 8392
Email: LORIS@trials.bham.ac.uk

Trial Entry

Telephone: 0121 4143017   (9.00 am till 5.00 pm Monday to Friday)

Serious Adverse Event Reporting

Fax: +44 (0)121 414 3017 

Sponsor

University of Birmingham

Quality of Life Coordinating Centre

QOL Trial Coordinator:  Miss Lucy Matthews

Sussex Health Outcomes, Research & Education in Cancer (SHORE-C), Brighton and Sussex Medical School, Brighton, BN1 9RX, UK

Telephone: +44 (0)1273 877919
Email:  L.Matthews@sussex.ac.uk