The purpose of this study is to evaluate the effect of local ablative treatment or embolisation or SIRT on circulating NET transcripts (PCR score or NETtest). In particular, the variation of circulating NET transcripts will be correlated to NET…
ID
Source
Brief title
Condition
- Endocrine neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effect of hepatic metastatic embolization (HAE/SIRT) on PCR score
Secondary outcome
1) Determine whether blood PCR score correlates with metastasis burden
2) Determine whether ablation efficacy and PCR score correlate with assessment
of tumor anatomical burden post-ablative imaging
3) Determine whether embolization/SIRT efficacy and PCR score correlate with
tumor assessment anatomical burden post embolisation
4) Correlate residual tumor burden using functional tumor imaging with PCR
score.
5) Evaluate stability/progression of tumor post ablation using PCR score vs.
patient parameters and imaging.
6) Comparison of plasma CgA measurements with the PCR score, for the same.
Background summary
Biomarker-based tools that can accurately predict gastroenteropancreatic
neuroendocrine tumor (GEP-NET) treatment response and tumor recurrence are
currently not available. Circulating biomarkers that are associated with
GEP-NETs are limited to measurements of plasma chromogranin A (CgA). Modlin et
al. have developed a PCR-based tool to quantitate (score) the circulating
GEP-NET molecular signature (*liquid* biopsy) with high sensitivity and
specificity21. This signature can identify all types of GEP-NETs including
small, non-metastatic tumors, is significantly reduced after tumor debulking
and is absent following surgical *cure*. Their observations indicate the score
is elevated before tumor recurrence is detected by RECIST criteria. Current NET
treatment protocols are associated with tumor recurrence (progression free
survival) ranging from 5 to 18 months. The majority of patients will experience
a relapse within 18 months irrespective of the treatment approach and most of
these patients develop liver metastasis only, who eventually will undergo a
local ablative therapy like Radiofrequency Ablation (RFA), Microwave Ablation
(MWA), or a (bland) liver embolization (TAE or SIRT). We hypothesize that a PCR
measurement of circulating NET mRNA can accurately predict tumor response after
local minimal invasive image guided treatment (RFA or MWA), or
liverembolisation . This biomarker protocol seeks to test this hypothesis and
evaluate this with the golden standard: CT scan.
Study objective
The purpose of this study is to evaluate the effect of local ablative treatment
or embolisation or SIRT on circulating NET transcripts (PCR score or NETtest).
In particular, the variation of circulating NET transcripts will be correlated
to NET recurrence to test whether this analysis may constitute an early
predictive marker of disease relapse.
Study design
Blood sampling schedule in 30 patients
• Whole blood will be collected at baseline (defined as prior to
SIRT/embolisation/ablative moment); three base-line bloods.
• Blood samples before and 15 mins after each embolic or ablative event during
the course of the procedure and day 5.
• Whole blood collected at each patient visit for the duration of study
(defined as time when cancer progression is detected on imaging).
• Serum for CgA analysis will be taken at the same time points as the
biomarker.
Intervention
Blood sampling schedule
• Whole blood will be collected at baseline (defined as prior to
SIRT/embolisation/ablative moment); three base-line bloods.
• Blood samples before and 15 mins after each embolic or ablative event during
the course of the procedure and day 5.
• Whole blood collected at each patient visit for the duration of study
(defined as time when cancer progression is detected on imaging).
• Serum for CgA analysis will be taken at the same time points as the
biomarker.
Study burden and risks
no risks associated with participation, no benefits associated with the study.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
• >= 18 years old with metastatic well differentiated neuroendocrine tumor of gastro-enteropancreatic origin who will undergo a local ablative treatment or HAE/SIRT .
• Patients have measurable disease
• WHO performance status 0-2
• Life expectancy more than 3 months
• Use of the standard embolization/RFA NET-NKI protocol
Exclusion criteria
1. Known history of HIV seropositivity.
2. contraindication for liverembolisation, RFA/MWA or SIRT
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 | NL52942.031.15 |