Pancreas Transplant RejectionPhase 1/2NCT03183258
Vascularised Sentinel Skin Flaps to Detect Rejection in Pancreas Transplantation
A Phase 1/2 study testing Sentinel skin flap in people with Pancreas Transplant Rejection, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This pilot study aims to validate the use of vascularised donor-derived sentinel skin flaps for diagnosing rejection in pancreas transplantation. The aim of the study is to investigate the use of sentinel skin flaps in clinical practice and assess whether rejection occurs concordantly or discordantly between the skin… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Transplant Rejection
- What is being tested?
- Sentinel skin flap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 May 2016to 1 Oct 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipient of a pancreas transplant (SPK or PTA)
- Participant is willing and able to give informed consent for participation in the study
- Male or Female, aged 18 years or above
Who cannot join
- Patient does not have a patent ulna artery in either forearm
- Recipient of an enterically drained PTA
- Patient has received any investigational medical drug within 30 days of transplantation
- Patient is not willing to return to Oxford for all clinical follow-up for 12 months
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the trial, or the participant's ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE
James CH Barnes, +447717707384, James.Barnes@nds.ox.ac.uk
About this study
This pilot study aims to validate the use of vascularised donor-derived sentinel skin flaps for diagnosing rejection in pancreas transplantation. The aim of the study is to investigate the use of sentinel skin flaps in clinical practice and assess whether rejection occurs concordantly or discordantly between the skin flap and the transplanted abdominal organs. If successful, sentinel skin may allow improved immune surveillance and thereby facilitate earlier treatment of rejection with subsequent improvements in allograft survival and patient morbidity.
- Conditions
- Pancreas Transplant Rejection
- Being tested
- Sentinel skin flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel skin flapOther
Donor-derived vascularised composite allograft (sentinel skin flap)
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Skin Flap | Experimental | Not described Receives: Other: Sentinel skin flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordant allograft rejection
If there is any clinical suspicion of rejection then both the sentinel skin flap and visceral allograft will be biopsied. Concordant rejection will be recorded where rejection is confirmed in both the sentinel skin flap and the visceral allograft.
Measured: 12 months
Secondary outcomes (5)
Discordant rejection of the sentinel skin
If there is any clinical suspicion of rejection then both the sentinel skin flap and visceral allograft will be biopsied. Discordant rejection will be recorded where there is rejection of the sentinel skin without rejection of the visceral allograft.
Measured: 12 months
Discordant rejection of the visceral allograft
If there is any clinical suspicion of rejection then both the sentinel skin flap and visceral allograft will be biopsied. Discordant rejection will be recorded where there is rejection of the visceral allograft without rejection of the sentinel skin.
Measured: 12 months
Donor specific antibodies
Development of de novo donor specific antibodies
Measured: 12 months
Immunosuppression
Total dose immunosuppression
Measured: 12 months
Graft survival
Pancreas allograft survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start19 May 2016
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas Transplant RejectionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter J Friend, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183258
- Sponsor's protocol ID
- 15/SW/0333
- Status last verified
- Apr 2019
- First submitted
- 5 Jun 2017
- Last updated
- 17 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascularised Sentinel Skin Flaps to Detect Rejection in Pancreas Transplantation
- ClinicalTrials.gov ID
- NCT03183258
- Acronym / sponsor ID
- 15/SW/0333
- Conditions
- Pancreas Transplant Rejection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 19 May 2016 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 12 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study aims to validate the use of vascularised donor-derived sentinel skin flaps for diagnosing rejection in pancreas transplantation. The aim of the study is to investigate the use of sentinel skin flaps in clinical practice and assess whether rejection occurs concordantly or discordantly between the skin flap and the transplanted abdominal organs. If successful, sentinel skin may allow improved immune surveillance and thereby facilitate earlier treatment of rejection with subsequent improvements in allograft survival and patient morbidity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sentinel Skin Flap | Experimental | Other: Sentinel skin flap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recipient of a pancreas transplant (SPK or PTA)
- Participant is willing and able to give informed consent for participation in the study
- Male or Female, aged 18 years or above
Key exclusion criteria (5 listed)
- Patient does not have a patent ulna artery in either forearm
- Recipient of an enterically drained PTA
- Patient has received any investigational medical drug within 30 days of transplantation
- Patient is not willing to return to Oxford for all clinical follow-up for 12 months
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the trial, or the participant's ability to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel skin flapDonor-derived vascularised composite allograft (sentinel skin flap) | Other | Sentinel Skin Flap |
Primary outcome
Concordant allograft rejection
Time frame: 12 months
If there is any clinical suspicion of rejection then both the sentinel skin flap and visceral allograft will be biopsied. Concordant rejection will be recorded where rejection is confirmed in both the sentinel skin flap and the visceral allograft.
5 secondary outcomes
Discordant rejection of the sentinel skin
Time frame: 12 months
Discordant rejection of the visceral allograft
Time frame: 12 months
Donor specific antibodies
Time frame: 12 months
Immunosuppression
Time frame: 12 months
Graft survival
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
Related trials for Pancreas Transplant Rejection
Not yet recruitingObservational study
Global Utilization And Registry Database for Improved preservAtion of doNor Pancreata (GUARDIAN-PANCREAS)
Pancreas (Including SPK) Transplantation, Pancreas Diseases
RecruitingPhase 3
A Multicenter Randomized Controlled Trial to Treat Acute T Cell Mediated Rejection in Kidney and Kidney-Pancreas Transplant Recipients
Rejection; Transplant, Kidney, Rejection; Transplant, Pancreas
RecruitingPhase 3
A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients
BK Viremia, Kidney Transplant Infection
Enrolling by invitationObservational study
The Norwegian Pancreas Transplantation (PTx) Study
Diabetes Mellitus, Pancreas Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J Friend principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sentinel skin flap in people with Pancreas Transplant Rejection, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James CH Barnes (+447717707384, James.Barnes@nds.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordant allograft rejection (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.