ASTIClite EBMT follow-up
| ISRCTN | ISRCTN31981313 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31981313 |
| Secondary identifying numbers | 36336 |
- Submission date
- 03/01/2018
- Registration date
- 19/01/2018
- Last edited
- 11/08/2022
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Digestive System
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 May 2021
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Lizzie Swaby
Contact information
Scientific
University of Sheffield
Room 2.11, Innovation Centre
c/o Regent Court, 30 Regent Street
Sheffield
S1 4DA
United Kingdom
Study information
| Study design | Observational; Design type: Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Autologous Stem cell Transplantation In refractory Crohn’s disease – Low Intensity Therapy Evaluation (ASTIClite) – long-term follow up through the EBMT |
| 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(s) | North West - Greater Manchester East Research Ethics Committee, 04/12/2017, ref: 17/NW/0669 |
| Condition | Crohn's disease |
| 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 |
| Primary outcome measure | 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 study start date | 01/08/2017 |
| Overall study end date | 31/05/2021 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 99; UK Sample Size: 99 |
| 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 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 | 21/06/2020 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Mays Jawad
The Royal London Hospital
Whitechapel
London
E1 1BB
England
United Kingdom
"ROR" |
https://ror.org/00b31g692 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Current publication and dissemination plan as of 09/03/2021: As the ASTIClite EBMT follow-up study was closed prior to any patients from the ASTIClite RCT trial rolled onto the follow-up study, there will be no results to publish for this study and participant-level data will not be available. Previous 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 plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 31/05/2019 | 11/08/2022 | Yes | No | |
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
11/08/2022: Publication reference added.
09/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2021 to 21/06/2020.
2. The overall trial end date was changed from 31/03/2026 to 31/05/2021.
3. It is no longer viable to run the EBMT long term follow-up study due to the limited number of patients recruited to the ASTIClite trial, as a result of early trial closure for safety reasons.
4. The publication and dissemination plan, IPD sharing statement and contact details were updated.
15/05/2020: The public contact has been updated.
08/05/2020: The public contact has been added.
28/03/2019: The condition has been changed from "Specialty: Gastroenterology, Primary sub-specialty: Inflammatory Bowel Disease; UKCRC code/ Disease: Oral and Gastrointestinal/ Noninfective enteritis and colitis" to "Crohn's disease" following a request from the NIHR.
16/03/2018: Updated primary contact name from Elizabeth to Lizzie
