The principal aim of this pilot study is to test whether ctDNA can be detected in peripheral blood of patients with an early CRC (i.e. pT1 CRC)
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The current proposal aims at defining whether ctDNA is detectable at sufficient
sensitivity in peripheral blood of pT1CRC patients.
Secondary outcome
not applicable
Background summary
As a consequence of the population-based screening programme for CRC in the
Netherlands, the incidence of early stage CRC (i.e. pT1CRC) has increased by
100%. Depending on the risk of lymph node metastases, some patients will need
an additional formal oncological surgical resection after local endoscopic
resection. At this moment, this risk assessment results in over-treatment of a
substantial proportion of pT1 CRC patients. It is generally accepted that
circulating free DNA (cfDNA) derived from tumor cells can be detected in
patients with mostly advanced disease. Mutation analysis of circulating free
tumor DNA (ctDNA) is currently used in daily clinical practice for monitoring
response to therapy in patients with advanced Non-Small Cell Lung Cancer.
However, little is known about the feasibility of monitoring early stage
disease behaviour by mutation analysis of ctDNA.
Study objective
The principal aim of this pilot study is to test whether ctDNA can be detected
in peripheral blood of patients with an early CRC (i.e. pT1 CRC)
Study design
Plasma from peripheral blood of patients undergoing endoscopic polypectomy of a
suspected malignant polyp will be collected at the moment of the endoscopic
examination. ctDNA will be isolated and Targeted NGS will be performed. The
removed malignant polyp will also be sequenced and the mutational patterns will
be compared.
This is a preclinical pilot study with a strong translational focus. Once we
have established the feasibility of this technique, it could be easily applied
in the follow up of these patients.
Study burden and risks
The burden of the procedure carried out in this study is very limited, as no
additional procedures are needed. Blood will be withdrawn during the endoscopic
procedure using an intravenous catheter that is required for the administration
of sedatives during the procedure. All studies will be performed on material
derived from regular endoscopic procedures.
albinusdreef 2
Leiden 2300RC
NL
albinusdreef 2
Leiden 2300RC
NL
Listed location countries
Age
Inclusion criteria
Patients with a colorectal lesion, endoscopically suspected malignant,
undergoing elective endoscopic resection.
Exclusion criteria
Severe anaemia (Hb < 6.0 mmol/L).
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL64827.058.18 |