To enumerate and characterize CTC in patients with solid malignancies before and, if applicable, after initiation of systemic treatment in order to improve the insight in the pathogenesis of metastases, and in mechanisms conferring resistance…
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To enumarate and characterize CTC's.
Secondary outcome
nvt
Background summary
There is a growing need to characterize the prognostic and predictive factors
of cancer patients better. In various tumor types a number of these factors are
indentified in the primary tumor (for example through a genetic profile).
Metastatic lesions are the primary cause of death in cancer patients. It is to
be expected that the characteristics of CTC's, who eventually will be formed to
metastases, are better predictable for the outcome of the patient than
characteristics found in the primary tumor. In this study in patients with
various malignancies CTC's will be enumareted and isolated for possible
prognostic and predictive factors. Next to CTC enumeration comparing
characteristics of CTC and the primary tumor will improve the insight in the
pathogenesis of metastases and the insight in mechanisms conferring resistance
against systemic treatments.
Study objective
To enumerate and characterize CTC in patients with solid malignancies before
and, if applicable, after initiation of systemic treatment in order to improve
the insight in the pathogenesis of metastases, and in mechanisms conferring
resistance against systemic treatments and to establish prognostic and
predictive models for clinical outcome.
Study design
In participating patients, a 30 ml. blood sample will be drawn. In patients who
will be treated with systemic therapy another 20 ml. blood sample will be drawn
3-4 weeks after start of the therapy. CTC will be enumerated and isolated.
Characteristics of the CTC's will be compared to amd asessed tp the available
characteristics of the primary tumor and clinical outcome.
Study burden and risks
None, blood samples will be drawn during regular visits for a blood check up of
the patient during treatment of his/her disease. There will not be taken extra
blood samples.
Groene Hilledijk 301
3075 EA ROTTERDAM
Nederland
Groene Hilledijk 301
3075 EA ROTTERDAM
Nederland
Listed location countries
Age
Inclusion criteria
- Patients suffering from one of the below mentioned solid malignancies. For patients with metastatic disease, only those who will be treated with first line systemic treatment will be recruited.
o metastatic breast cancer (number 100-150)
o localized breast cancer (number 100-150)
o metastatic colorectal cancer (number 100-150)
o localized colorectal cancer (number 100-150)
o metastatic prostate cancer (number 100-150)
o metastatic other tumor types such as testicular cancer, soft tissue sarcoma, renal cell carcinoma, lung carcinoma (in total maximum number 100-150);- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.;- Before patient randomization, written informed consent must be given and documented to ICH/EU GCP, and national/local regulatory requirements and the local rules followed in the institution
Exclusion criteria
Geen
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 | NL12101.078.06 |