Condition category
Cancer
Date applied
22/06/2009
Date assigned
28/09/2009
Last edited
09/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Susan Harden

ORCID ID

Contact details

Oncology Centre
Box 193
Cambridge University Hospitals NHS Foundation Trust
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
-
susan.harden@addenbrookes.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CLUB01 version 1.0 May 2009

Study information

Scientific title

A non-randomised controlled single centre study to investigate the role of advanced brain magnetic resonance imaging techniques in small cell lung cancer

Acronym

CLUB01

Study hypothesis

We hypothesise that by developing ways to look for subtle changes in magnetic resonance imaging (MRI) images before the cancer deposits (metastases) themselves are big enough to be visualised by current methods, we may be able to predict which patients are most at risk for developing brain metastases.

Ethics approval

Cambridgeshire 1 Research Ethics Committee (REC), ref: 09/H0304/59, expected to be approved on 21/07/2009

Study design

Non-randomised controlled single-centre study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please contact CCTC at Addenbrooke's Hospital: +44 (0)1223 216083 to request a patient information sheet

Condition

Small cell lung cancer

Intervention

This is a single centre non-randomised observational imaging feasibility study. There will be a maximum of 4 MRI scans (interventions) over a 1 year period and the total duration recruitment will be 2 years, therefore a study duration of 3 years to complete the interventions with routine clinical follow-up to 5 years as standard.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Identification of the subset of SCLC patients at high risk for developing brain metastases, based on novel imaging at diagnosis, correlated retrospectively with clinical outcome.

Secondary outcome measures

Radiological disease progression:
1. Local incidence of asymptomatic brain metastases detected by conventional MRI at diagnosis
2. Local incidence of brain metastases detected after chemotherapy by conventional MRI

Overall trial start date

01/09/2009

Overall trial end date

09/11/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ability to give written informed consent
2. Aged greater than 18 years, either sex
3. Histologically or cytologically confirmed small cell lung cancer
4. No previous malignancy
5. No prior chemotherapy
6. Satisfactory renal function (ethylenediaminetetraacetic acid [EDTA] clearance greater than 60 ml/min)
7. Satisfactory World Health Organization (WHO) performance status 0, 1 or 2

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20 sequential patients

Participant exclusion criteria

1. Prior chemotherapy or radiotherapy to primary tumour
2. Central nervous system (CNS) disease
3. Previous or coexistent malignancies
4. Pregnancy or breastfeeding
5. Any other medical condition making participation in a clinical trial undesirable

Recruitment start date

01/09/2009

Recruitment end date

09/11/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cambridge University Hospitals NHS Foundation Trust
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Trust R&D Dept
Box 277
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

Government

Website

http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes