Condition category
Cancer
Date applied
14/09/2005
Date assigned
25/10/2005
Last edited
10/09/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Peter Sasieni

ORCID ID

Contact details

Wolfson Institute
Queen Mary College
Charterhouse Square
London
EC1M 6BQ
United Kingdom
+44 (0)207 014 0260
peter.sasieni@cancer.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00462813

Protocol/serial number

N/A

Study information

Scientific title

Acronym

CRISP-1

Study hypothesis

DIM® will prevent progression and accelerate regression of cervical intra-epithelial neoplasia.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cervical neoplasia.

Intervention

Double-blind, placebo-controlled trial. Randomisation is in the ratio 2 DIM®: 1 placebo.
Diindolylmethane (BioResponse DIM® - 75 mg capsules) - two capsules daily for 6 months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Reduction in cervical intra-epithelial neoplasia grade 2 (CIN2) or worse.

Secondary outcome measures

Cytology, lesion size, human papillomavirus (HPV) status (all at 6 months).

Overall trial start date

25/10/2005

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Women with a first mildly dyskaryotic smear or a second borderline smear taken within the Cervical Screening Wales (CSW) programme will be invited to participate in the trial.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

3000

Participant exclusion criteria

N/A

Recruitment start date

25/10/2005

Recruitment end date

31/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolfson Institute
London
EC1M 6BQ
United Kingdom

Sponsor information

Organisation

Queen Mary and Westfield College, University of London (UK)

Sponsor details

Joint R and D Office
3rd Floor Rutland House
42-46 New Road
London
E1 2AX
United Kingdom
+44 (0)207 882 7272
Helen.Cadiou@bartsandthelondon.nhs.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (C8162/A4609).

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22075942

Publication citations

  1. Results

    Castañon A, Tristram A, Mesher D, Powell N, Beer H, Ashman S, Rieck G, Fielder H, Fiander A, Sasieni P, Effect of diindolylmethane supplementation on low-grade cervical cytological abnormalities: double-blind, randomised, controlled trial., Br. J. Cancer, 2012, 106, 1, 45-52, doi: 10.1038/bjc.2011.496.

Additional files

Editorial Notes