The main objective is to assess the feasibility of CTC organoid culture as a diagnostic and/or prognostic tool in patients with metastatic disease.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the number of patients from which viable Organoids
can be cultured from CTCs. On the basis of this number prognostic follow up
studies can be designed. With a success rate of 70% the study will be proven
feasible.
Secondary outcome
Not applicable
Background summary
Mortality from colorectal cancer (CRC) is frequently due to the development of
liver metastases. Clinicopathological features have limited power to identify
patients at risk of relapse. The presence of circulating tumour cells (CTCs)
may help to discriminate between patients with high and low risks of developing
distant metastases. For CTCs to be used as a prognostic biomarker however, the
sensitivity and specificity of detection need to be improved. Drawing blood
from the portal vein, instead of using peripheral blood, increases the
detection rate of CTCs. Assessment of regenerative potential of CTCs could
provide information on the ability of CTCs to form liver metastases. By
combining CTC purification from portal blood with organoid culture
technologies, we aim to optimize the performance of CTCs as a prognostic tool.
Study objective
The main objective is to assess the feasibility of CTC organoid culture as a
diagnostic and/or prognostic tool in patients with metastatic disease.
Study design
A multi-centre feasibility study
Study burden and risks
No additional hospital visits are needed for this trial: blood samples will be
collected during surgery. The risk of complications during portal venous blood
collection is small since the collection of the sample will take place at the
start of the procedure, the surgeon has a direct view of the portal vein during
the rest of the procedure. Control of the puncture spot on the portal vein will
be checked before the procedure is ended.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
1. Male or female aged *18 years;
2. Clinical diagnosis of colorectal carcinoma with synchronous liver metastases;
3. Scheduled resection of the primary tumour or resection of liver metastases
with a liver-first approach;
4. Written informed consent.
Exclusion criteria
-
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63625.041.17 |