The primary objective is to gain more insight in molecular alterations in CSU by performing a broad set of molecular analysis on tissue and blood ofpatients with carcinosarcoma of the uterus and find (bio)markers which can be linked to the clinical…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Cervix disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
molecular characterization of the obtained tumor tissue, liquid biopsies and
papsmear.
Secondary outcome
Quality of life-questionnaires and registration of clinical outcomes of
included subjects.
Background summary
Carcinosarcoma of the uterus (CSU) is a rare and aggressive tumor with a poor
prognosis. (1) CSU has a high rate of relapse and a poor response on
adjuvant therapy. Due to this aggressive character, CSU is often excluded from
clinical studies on endometrial cancer and therefore little is known
about optimal treatment.
There are only few studies on common genomic alterations in CSU. Even less is
known about the relation between molecular alterations and clinical
outcomes.
At the Erasmus MC the *carcinosarcoma of the uterus-study* (CUS) started 6
years ago with the aim to describe clinical outcomes and report the
quality of life via questionnaire. In addition with this new study we hope to
combine knowledge of the molecular characteristics with the clinical
outcome to have better understanding about the CSU, to find markers for
targeted therapy and early diagnosis to eventually increase the prognosis.
Study objective
The primary objective is to gain more insight in molecular alterations in CSU
by performing a broad set of molecular analysis on tissue and blood of
patients with carcinosarcoma of the uterus and find (bio)markers which can be
linked to the clinical outcome or targets for adjuvant therapy.
Study design
This is an observational and exploratory study with molecular analysis on
tissue, liquid biopsies (blood) and papsmear; and describing the clinical
outcomes and quality of life questionnaires.
Study burden and risks
Blood will be drawn before treatment, after first chemotherapy (if applicable),
pre-operative, after surgery (if applicable), at the end of treatment and 1
year after end of treatment. Also in case of a relapse, we want to analyse the
blood. These timepoints are as much as possible combined with the
routine outpatient clinics after treatment, to reduce the burden. There is a
preference that this will be combined with blood drawn for clinical purposes.
We need 20 mL of blood per time point
Molecular analysis will be performed on residual tumor tissue which has been
obtained already for diagnosis and treatment. As this study will not
change treatment nor randomize patients, participation in this study will not
change patient outcome. The goal is to find targets for future therapies,
therefore participants will not benefit from the findings of this study
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Female patients older than 18 year who are diagnosed with a histologically
confirmed CSU. Patients will be asked to sign informed consent.
Patients are also able to choose if they want to participate in a part of the
study (molecular analysis, registration of clinical outcomes and/or
participation in quality of life questionnaires). Patients who are already
included for the CUS-study can for additionally join the CUS II study for the
molecular analysis.
Exclusion criteria
Patients who are not able to fill in the questionnaires due to language (Dutch)
or who are not mentally competent are excluded for the part of quality of life.
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 | NL82192.078.22 |