Research question and hypothesis Research questions1 Are there tumourmarkers available which can be measured intracellular by flowcytometry during neoadjuvant treatment of patients with breast cancer?2 Can we measure the effect of neoadjuvant…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This research will focus on women with a locally or advanced carcinoma of the
breast and who will receive neoadjuvant treatment in the Atrium Medisch Centrum
in Heerlen. The primary outcome will be the changes in concentration of
tumourmarker containing macrophages in relation to changes in tumour size as
measured by MRI and pathologic respons.
Secondary outcome
not applicable
Background summary
Around 13,000 women will be diagnosed with invasive breast cancer each year in
the Netherlands. Almost 1,300 women will be diagnosed with a ductal carcinoma
in situ. Women have a 12 to 13 percent chance to develop a malignancy of the
breast. Breast cancer is the most common type of cancer in the dutch female
population. There has been a substantial decline in breast cancer mortality,
and a major contributor is (neo)adjuvant medical therapy. Several arguments
apply for chemotherapy in a so-called neoadjuvant treatment setting, prior to
surgery. First, downstaging the tumour leads to less extensive resections and
breast conservation becomes increasingly feasible. Second, micrometastases that
may be present are thus treated at the earliest possible moment. A third
advantage of neoadjuvant chemotherapy is that it enables the monitoring of
treatment efficacy and makes it possible to identify markers of response to
chemotherapy.
Accurate modalities for assessing chemotherapy response are critical to the
evaluation and expansion of the use of neoadjuvant therapy for breast cancer.
Conventional methods including clinical examination, mammogram, and breast
ultrasound are incorrect in identifying pathologic complete response patients
in nearly half of the cases.
During the last decennia, several biomarkers have been identified which could
be used for monitoring neoadjuvant treatment in women with breast cancer. Until
now, none of these markers has had sufficient diagnostic accuracy to monitor
neoadjuvant treatment. In this study, we want to investigate if measuring
biomarkers inside activated macrophages by means of flowcytometric analysis can
monitor the effect of neoadjuvant therapy.
Study objective
Research question and hypothesis
Research questions
1 Are there tumourmarkers available which can be measured intracellular by
flowcytometry during neoadjuvant treatment of patients with breast cancer?
2 Can we measure the effect of neoadjuvant treatment of patients with breast
cancer by flowcytometrical analysis of M30, CA 15,3, CEA and Her2 inside
acrivated macrophages?
Hypothesis
1 Tumourmarkers as measured inside activated macrophages can ben measured by
flowcytometry during neoadjuvant treatment of patients with breast cancer.
2 The flowcytometric measurement of M30, CA15,3, CEA and Her2 inside activated
macrophages can monitor the effects of neoadjuvant therapy in patients witth
breast cancer.
3 The flowcytometric measurement of CA15,3 and CEA inside activated macrophages
can monitor the effects of neoadjuvant therapy in patients witth breast cancer
more accurate than the measurements of CA15,3 and CEA in serum.
Study design
Prospective pilot-study in which a new diagnostic test, the measurement of
tumourmarkers in activated macrophages, will be investigated.
Study burden and risks
The burden for the studygroup is very low. The course of the disease and
treatment will not be influenced by this study.
Henry Dunantstraat 5
6401PC Heerlen
Nederland
Henry Dunantstraat 5
6401PC Heerlen
Nederland
Listed location countries
Age
Inclusion criteria
Men and women diagnosed with primary or recurring breast cancer who will receive neoadjuvant systemic therapy.
Exclusion criteria
Not being able to agree with the informed consent procedure.
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 | NL30514.096.09 |