- special attention for the development and harmonization of the pre-analysis of liquid biopsy, for blood as well as urine, and next to this for ctDNA as well as ctRNA- special attention for the detection of AR-V7 in blood and urine- special…
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- relation between de absence/presence of specific mutations in blood vs
primary tumor (with special attention to AR-V7 and BRCA 1/2)
- response on therapie
Secondary outcome
- relation between de absence/presence of specific mutations in urine vs
peripheral blood (with special attention to AR-V7 and BRCA 1/2)
- response on therapie
Background summary
- detection of specific mutations in circulating tumor DNA in blood or urine
- in use for a personalised medicine of the patient: tailor-made treatment of
the patient with the use of presence/absence of specific mutations as guidance
Study objective
- special attention for the development and harmonization of the pre-analysis
of liquid biopsy, for blood as well as urine, and next to this for ctDNA as
well as ctRNA
- special attention for the detection of AR-V7 in blood and urine
- special attention for the detection of BRCA1/2 in blood and urine
Simultaneously also the development of a protocol for its detection in tissue
Study design
Pre-analysis Isolation of cfDNA/RNA from blood and urine
- which type of matrix (blood, urine, saliva)
- which type of collection tube
- use of additiative
- transport conditions primary sample
- storage conditions primary sample
- possible time till isolation
- centrifugation protocol
- storage conditions isolated ctDNA/RNA
Development molecular panel
- special attention to AR-V7 splice variant (detection in tissue, blood and
urine)
- special attention to BRCA 1/2 (detection in tissue and blood)
Study burden and risks
not applicable
dr. H. van der Hoffplein 1, Sittard-Geleen 1
Sittard-Geleen 6162 BG
NL
dr. H. van der Hoffplein 1, Sittard-Geleen 1
Sittard-Geleen 6162 BG
NL
Listed location countries
Age
Inclusion criteria
- patients with metastasized castrate-resistant prostate carcinoma (mCRPC)
- patients with metastasized hormone-sensitive prostate carcinoma (mHSPC)
Exclusion criteria
- no other malignancies
- no biopt of the prmary tumor
- patients treated with radio-isotopes
- no informed consent
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 | NL68319.096.20 |