Protocol for the donation of samples by volunteers for laboratory research
| ISRCTN | ISRCTN13109642 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13109642 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 149078 |
| Protocol serial number | DS-10-01, IRAS 149078, 46616 |
| Sponsor | Medicines Evaluation Unit |
| Funder | Investigator initiated and funded |
- Submission date
- 02/02/2023
- Registration date
- 03/02/2023
- Last edited
- 18/04/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study aims to obtain blood and/or urine, stool, skin, sputum, saliva, mucosal or nasal samples from healthy volunteers and patient volunteers for laboratory research, relating to the causes and treatment of disease, in order to identify markers of disease and drug effect or development of new laboratory methods.
Who can participate?
Men and women 18 years old or over
What does the study involve?
This study will involve ad hoc visits to the Medicines Evaluation Unit. After written informed consent is obtained, participants will be assessed for their eligibility to donate the samples required according to the specific procedure to be undertaken. Participants have one or more of the following samples taken at a single visit: sputum, blood, urine, nasal, stool or skin.
What are the possible benefits and risks of participating?
All sampling procedures are considered safe. There is a small risk of side effects such as bruising, bleeding and infection. This is laboratory research so there is no direct benefit to the participant.
Where is the study run from?
Medicines Evaluation Unit (UK)
When is the study starting and how long is it expected to run for?
November 2009 to December 2030
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Clinical Research Leader
Contact information
Public
MEU
The Langley Building
Southmoor Road
Manchester
M23 9QZ
United Kingdom
| Phone | +44 (0)1619464065 |
|---|---|
| njackson@meu.org.uk |
Scientific
MEU
The Langley Building
Southmoor Road
Manchester
M23 9QZ
United Kingdom
| Phone | +44 (0)1619464065 |
|---|---|
| njackson@meu.org.uk |
Principal investigator
MEU
The Langley Building
Southmoor Road
Manchester
M23 9QZ
United Kingdom
| Phone | +44 (0)1619464073 |
|---|---|
| dsingh@meu.org.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cross sectional study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Protocol for the donation of blood, urine, stool, dermatological, sputum and nasal samples by healthy volunteers and patient volunteers for laboratory research |
| Study objectives | Identifying markers of disease and developing new assays |
| Ethics approval(s) | Approved 12/04/2010, North West Preston Research Ethics Committee (HRA Centre Manchester, Barlow House, 3rd Floor, 4 Minshull Street, Manchester M1 3DZ, UK; +44 (0)2071048290; preston.rec@hra.nhs.uk), ref: 10/H1016/25 |
| Health condition(s) or problem(s) studied | Healthy volunteers and patient volunteers of all conditions |
| Intervention | Participants have one or more of the following samples taken at a single visit: sputum, blood, urine, nasal, stool or skin. |
| Intervention type | Other |
| Primary outcome measure(s) |
Sputum eosinophil counts in stable state measured using cytology at a single timepoint |
| Key secondary outcome measure(s) |
Sputum supernatant cytokines including IL-8 and TNF-α in stable state measured using immunoassay at a single timepoint |
| Completion date | 31/12/2030 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 2000 |
| Key inclusion criteria | 1. Able to give written informed consent 2. Males and females aged over 18 years 3. Procedure specific criteria |
| Key exclusion criteria | 1. History of anaemia or identified by haemocue test at screening or other clinically significant haematological disorders for blood donation 2. Current acute illness 3. Pregnancy or breastfeeding 4. History of Hepatitis B/C or HIV infection or a positive test at screen if required by the specific project 5. Volunteers who have donated to the blood transfusion service in the past 4 months, if applicable (applicable for blood donation or if specified for other procedures as per project-specific exclusion criteria) 6. Suspected use of drugs of abuse or positive drug screen, if required 7. Any contraindications for nasal sampling e.g. history of epistaxis, nasal defects, as assessed by the physician 8. Procedure-specific criteria and contraindications for performing the specific procedure 9. Any reason that the physician deems the subject not suitable to undertake the procedure(s) |
| Date of first enrolment | 07/05/2010 |
| Date of final enrolment | 31/12/2029 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Southmoor Road
Wythenshawe
Manchester
M23 9QZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the exploratory nature of the research and assays. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/04/2024: A study contact confirmed the record required no changes at this time.
02/03/2023: IRAS number added.
03/02/2023: Trial's existence confirmed by the North West Preston Research Ethics Committee.
