Rationale: The purpose of this project is to investigate the presence and course of natural WT1-specific and PRAME-specific immunity in EOC patients, with the intent to exploit the obtained knowledge of WT1-specific and PRAME-specific immunity for…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quantification and qualitative analysis of WT1-specific and PRAME-specific
cellular and humoral immunity in patients with EOC during standard therapy.
Secondary outcome
NA
Background summary
Evidence of involvement of the immune system in epithelial ovarian cancer (EOC)
is widely available. In an attempt to exploit the immune system to improve
prognosis of this disease, immunotherapy is under development. To this end, it
is pivotal to understand what targets the immune system uses for its anti-tumor
responses. Two possible targets are WT1 and PRAME.
Study objective
Rationale: The purpose of this project is to investigate the presence and
course of natural WT1-specific and PRAME-specific immunity in EOC patients,
with the intent to exploit the obtained knowledge of WT1-specific and
PRAME-specific immunity for the development of WT1-specific and/or
PRAME-specific immunotherapy for this disease entity.
Specific objectives:
1. detection of WT1-specific and PRAME-specific immunity in patients with EOC
2. determination of the effect of standard therapy on WT1-specific and
PRAME-specific immunity
3. determination of the optimal timing of leukapheresis for further development
of WT1-specific and/or PRAME-specific adoptive T-cell transfer therapy.
Study design
prospective observational study
Study burden and risks
Participants will be asked to give three blood samples during their normal
diagnostic and therapeutic work-up. The first sample will be obtained prior to
start of therapy (220 ml), the second sample will be obtained after the third
course of chemotherapy (60 ml), the last sample will be obtained 4 weeks after
completion of therapy (220 ml). Patients who are referred to the University
Medical Center Groningen for cytoreductive surgery who have already received
three cycles of neoadjuvant chemotherapy will also be included. Therefore the
first sample (220ml) will be skipped, the second and last samples will be
obtained according to the protocol, respectively after the third cycle of
chemotherapy (60 ml), and 4 weeks after completion of therapy (220 ml). Blood
collections will be combined with regular hospital visits and when possible
with routine venapunction for diagnostic purposes. Risk of participation is
considered minimal as ordinary venapunction will be performed. Patients will
not benefit from participation in the study. The ultimate goal of this study is
to aid the development of immunotherapy for ovarian cancer. To this end it is
necessary to gain further insight into natural immune responses to tumour
antigens in patients with epithelial ovarian cancer.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
- women newly diagnosed with epithelial ovarian cancer; prior to treatment or after neoadjuvant chemotherapy prior to cytoreductive surgery
- adequate venous access for blood collection
- 18 years of age or older
- informed consent
Exclusion criteria
- previous or concurrent malignancies, other than basal or planocellular cancer of the skin
- concurrent immunosuppressive therapy, other than chemotherapy for ovarian cancer
- recurrent epithelial ovarian cancer
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 | NL42448.042.12 |