Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05650125 |
| Other study ID # |
174008 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
January 1, 2030 |
Study information
| Verified date |
June 2024 |
| Source |
University of Liverpool |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Generating bespoke biosampling protocols for individual tumour specific translational
projects is onerous, cumbersome and inefficient. This study aims to provide a broad platform
to maximise the unique access to biopsy and resected tumour specimens available from cancer
patients to provide a high-quality and efficient source of biosamples for specific
translational projects. Access to historical FFPE samples and clinical data, as well as
prospective fresh tissue samples, will allow interrogation of the underlying biology of these
cancers. Matched pseudoanonymised clinical and radiological data will allow the development
of rich high-yield datasets.
Description:
This is a platform tissue collection study to provide biosamples for specific research
projects. These sub-studies will be proposed by interested researchers and undergo internal
review by the PINCER steering committee. Following approval, each sub study will be delivered
on this platform in line with this protocol. This study will not be used to generate
biobanks, but to allow biosamples to be used for specific active sub studies.
1. Study Locations & Approval This platform will allow patients having surgery or biopsy
for any solid organ cancer to consent to take part in the study. Any site wishing to do
this will open as a site for the PINCER Study. Sub-studies using PINCER will require
their own local study lead and SOP written by the local team and this will require
approval by the PINCER steering committee. This will be to confirm alignment with the
overarching PINCER protocol, define sampling requirements and assess the scientific
validity of the study, as well as ensure regulatory oversight.
2. Fresh Tissue Collection Tissue will be obtained either through biopsy (an extra sample
of tissue will be taken using the same needle at the time of original biopsy) or after
surgical resection (where the tumour tissue would routinely be discarded after sampling
for pathological assessment). In the case of tissue retrieved after surgery, a
pathologist will ensure that excess tissue removed after resection will not compromise
pathological assessment of the resected specimen.
At the same time as biopsy or surgery, a small sample of blood (60ml) may be removed
from the venous catheter which the patient has inserted as part of the routine care
during their procedure. After the tissue has been retrieved, tissue and blood will be
transported to a HTA approved facility. This will be performed under a locally arranged
material transfer agreement (MTA) agreed by the local team between each individual site
and the relevant partner organization.
3. Collection of historical FFPE tumour tissue Patients who have undergone biopsy or
surgery for solid organ cancers will be identified from existing NHS clinical databases
which track surgical activity by relevant clinical teams. Their tumour tissue samples
will then be identified using local pathology systems, and their archived tissue blocks
retrieved. In the case of patients who have had metastatic disease resected, both
primary and metastatic tumour tissue will be accessed. A small amount of these tissue
blocks will be sampled, and the remnant tissue block returned to the pathology archive.
After the tissue has been retrieved, it will be transported to a HTA approved facility.
This will be performed under a locally arranged material transfer agreement (MTA)
between each individual site and the relevant partner organization.
4. Collection of post-treatment blood samples Up to 60mls of blood may be drawn from
patients up to 12 months following treatment. After the blood has been retrieved, it
will be transported to a HTA approved facility. This will be performed under a locally
arranged material transfer agreement (MTA) between each individual site and the relevant
partner organization.
5. Quality of Life Analysis Where appropriate, patients will be invited to complete EORTC
Quality of Life assessment questionnaires up to 12 months following treatment.
6. Pseudoanonymised data & radiology collection Linked clinicopathological and radiological
data will be retrieved where appropriate and stored on password protected computer
systems. Local pseudoanonymisation will be required before these data are shared with
other researchers not directly involved in the clinical care of patients.
7. Biosample analysis All analyses will be performed in HTA approved laboratories or
equivalent. Pseudoanonymised samples may be shared with academic and commercial partner
organisations within the UK and abroad, including the USA. All users of biosamples will
be expected to have completed MRC HTA training.
