Condition category
Digestive System
Date applied
03/01/2018
Date assigned
19/01/2018
Last edited
16/03/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Crohn's disease is a long-term condition that causes inflammation of the lining of the digestive system. There is no cure at the moment, and current treatments only reduce symptoms, and often have intolerable side effects. In some patients, current treatments only provide temporary benefit, or they fail to respond at all. An alternative therapy is haematopoetic stem cell transplantation (HSCT). This treatment is being assessed in the ASTIClite study, and this study aims to assess the long-term safety and effectiveness of this procedure.

Who can participate?
Patients with Crohn's disease taking part in the ASTIClite study

What does the study involve?
Data collected from the point of stem cell transplant (or equivalent day 0 in the control group) are entered into a database, along with annual follow-up data for at least four years after the end of the study. This data collection takes place in standard care for all patients undergoing transplantation, but this study collects the data for all participants, regardless of whether they have had a transplant or continued on usual care.

What are the possible benefits and risks of participating?
It is not known whether HSCT offers long term benefits for patients with Crohn's disease, and this is the reason for carrying out this study. If the treatment is found to be more effective than the usual care patients receive, this will inform the treatment of future patients with Crohn's disease. By taking part in the study, participants are directly helping to do this. Participants are contacted for an annual visit with the study nurse, and are provided with their contact details so they have someone to contact with any questions or concerns. Taking part in this study may mean an additional burden of appointments at the recruiting NHS Trust, but it is likely that for most participants this burden is in line with their usual care had they not been part of a study. It is not currently known what the long term effects of HSCT are, and there is therefore the possibility of late side effects of the treatment. Participants are provided with the contact details of their local research team, their GP is informed of their participation in the study, and participants are advised to contact the study team with any questions or concerns.

Where is the study run from?
University of Sheffield (UK)

When is the study starting and how long is it expected to run for?
August 2017 to March 2026

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Lizzie Swaby

Trial website

Contact information

Type

Scientific

Primary contact

Miss Lizzie Swaby

ORCID ID

Contact details

University of Sheffield
Room 2.11
Innovation Centre
c/o Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

36336

Study information

Scientific title

Autologous Stem cell Transplantation In refractory Crohn’s disease – Low Intensity Therapy Evaluation (ASTIClite) – long-term follow up through the EBMT

Acronym

Study hypothesis

Crohn's disease is a long term condition that causes inflammation of the lining of the digestive system. There is no cure at the moment, and current treatments only reduce symptoms, and often have intolerable side effects. In some patients, current treatments only provide temporary benefit, or fail to respond at all. An alternative therapy is haematopoetic stem cell transplantation (HSCT). This treatment is being assessed in the ASTIClite randomised controlled trial, and this study aims to assess the long term safety and efficacy of this procedure.

Ethics approval

North West - Greater Manchester East Research Ethics Committee, 04/12/2017, ref: 17/NW/0669

Study design

Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Specialty: Gastroenterology, Primary sub-specialty: Inflammatory Bowel Disease; UKCRC code/ Disease: Oral and Gastrointestinal/ Noninfective enteritis and colitis

Intervention

Participants recruited to the ASTIClite RCT will be invited to take part in the EBMT follow-up study, and will sign a separate consent form. Data collected from the point of stem cell transplant (or equivalent day 0 in the control group) will be entered into the EBMT database, along with annual follow up data for at least four years after the end of the RCT. This data collection takes place in standard care for all patients undergoing transplantation, but this research will collect the data for all participants, regardless of whether they have had a transplant, or continued on usual care.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Documentation of adverse events; Timepoint(s): At each annual follow up visit (four to seven years)

Secondary outcome measures

Participants are followed up annually for between 4 - 7 years, depending on when they are recruited to the ASTIClite RCT. Secondary outcome measures for the follow up study are as follows:
1. Long-term efficacy (for those patients receiving HSCT), measured using documentation of the need for further treatment at each annual follow up visit
2. Documentation of disease activity at each annual follow up visit
3. Requirement for further medical or surgical intervention at each annual follow up visit
4. Disease-specific quality of life measured using the IBD-Q questionnaire at each annual follow up visit
5. Disease-specific quality of life measured using the IBD Control questionnaire at each annual follow up visit
6. Quality of life measured using the EQ-5D-5L questionnaire at each annual follow up visit
7. Health care resource utilisation measured using the healthcare resource use questionnaire at each annual follow up visit

Overall trial start date

01/08/2017

Overall trial end date

31/03/2026

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants must have consented to take part in the ASTIClite randomised controlled trial (see http://www.isrctn.com/ISRCTN17160440)
2. Participants must be willing and able to provide full informed consent, including sharing their data with the EBMT

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 99; UK Sample Size: 99

Participant exclusion criteria

Significant language barriers, which are likely to affect the participant’s understanding of the study, or ability to complete outcome questionnaires

Recruitment start date

01/04/2018

Recruitment end date

31/03/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Sheffield
-
United Kingdom

Sponsor information

Organisation

Barts Health NHS Trust

Sponsor details

c/o Mays Jawad
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 15/178/09

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The protocol will be made available on the website of the trial funder (NIHR EME) at https://www.journalslibrary.nihr.ac.uk/programmes/eme/1517809/#/. Planned publication of the results in a high-impact peer reviewed journal in late 2026/early 2027.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2026

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/03/2018: Updated primary contact name from Elizabeth to Lizzie