- special attention for the development and harmonization of the pre-analysis of liquid biopsy, for blood as well as urine, andnext to this for ctDNA- special attention for the detection of PIK3CA mutations in blood and urineSimultaneously also the…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- relation between de absence/presence of specific PIK3CA mutations in blood vs
primary tumor
Secondary outcome
- relation between de absence/presence of specific PIK3CAmutations in urine vs
peripheral blood
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
- special attention for the detection of PIK3CA mutations in blood and urine
Simultaneously also the development of a protocol for its detection in tissue
Study design
Pre-analysis Isolation of cfDNA 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
Development molecular panel
- special attention to PIK3CA mutations (detection in tissue, blood and urine)
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 a metastasized mammacarcinoma
Exclusion criteria
- no other malignancies
- no biopt of the primary tumor
- patients younger than 16 years
- 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 | NL82677.096.22 |