Improving isolation and characterization technologies for CTC.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The blood specimens will be used to isolate, enumerate, and characterize the
circulating cells. Fluorescently labeled antibodies for tumor specific and/or
tissue specific markers among others will be used to identify, count and
characterize the circulating cells. The blood samples and isolated cells may
also be used for the detection of altered, over-, or under-produced
cancer-related molecules, including gene expression studies of genes that may
be related to the response of cancer cells to therapeutics. Genetic studies
will be done to determine their importance in response to therapies, not to
test for genetic sequences for the purpose of identifying inherited genetic
disorders. Remaining blood samples and their components may be saved for
possible use in future investigations related to cancer research, including
detection of altered, over-, or under-produced cancer-related molecules.
Secondary outcome
Not applicable
Background summary
The presence of circulating tumor cells (CTCs) in patients with metastatic
breast, colorectal and prostate cancer is strongly associated with a short
progression free and overall survival. Failure to eliminate CTCs after the
first cycle(s) of therapy is indicative for a futile therapy. Various studies
are ongoing how to best use CTC in the management of the disease of patients
with metastatic carcinomas. At Twente University technology is being developed
to further improve the identification and characterization of Circulating Tumor
Cells and blood of cancer patients is needed for these studies.
Study objective
Improving isolation and characterization technologies for CTC.
Study design
This study will be an Institutional Review Board (IRB) approved single-site,
single blind case study. A maximum of 40mL (approximately 8 teaspoons) of
whole blood per draw will be used to determine the ability of various in-vitro
tests to isolate circulating cells and/or their components, to compare
circulating cell enumeration by fluorescent image analysis and/or flow
cytometric methods, to evaluate the stability of the circulating cells and
integrity of genetic material (i.e. RNA and DNA), and to characterize the
circulating cells and/or cellular components isolated from advanced cancer
patients using protein RNA and or DNA analyses.
Study burden and risks
Not applicable
Drienerlolaan 5
7522NB Enschede
NL
Drienerlolaan 5
7522NB Enschede
NL
Listed location countries
Age
Inclusion criteria
Minimal age 18 years
Diagnosis Stage IV solid carcinoma
Minimum of seven days since last therapie (exept daily administration therapies)
Signed informed consent form
Exclusion criteria
Under the age of 18 years
Early stage disease
Patients unwilling/unable to give 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 | NL30621.044.09 |