Primary objective:To identify common mutations or other genetic alterations and their potential as therapeutic targets in granulosa cell tumours, by studying human granulosa cell tumour specimens and establishing 3D organoid cell cultures derived…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of the proposed investigation is the identification of novel
therapeutic targets in granulosa cell tumours, by first identifying common
mutations or other genetic alterations and subsequently performing drug screens
in tumour organoid cell cultures to study the effect of targeting the observed
aberrations in human granulosa cell tumour samples.
Secondary outcome
The presence of circulating tumour DNA (ctDNA) in plasma of granulosa cell
tumour patients, and its value as a diagnostic marker for tumour load.
Background summary
Granulosa cell tumours are non-epithelial ovarian malignancies that account for
approximately 2% of ovarian cancers. Although they are often diagnosed at an
early stage and the prognosis is generally favorable, recurrences occur in one
third of patients and lead to higher morbidity and mortality rates. A better
insight in the molecular background of granulosa cell tumours may offer novel
treatment options.
Study objective
Primary objective:
To identify common mutations or other genetic alterations and their potential
as therapeutic targets in granulosa cell tumours, by studying human granulosa
cell tumour specimens and establishing 3D organoid cell cultures derived from
human granulosa cell tumours.
Secundary objective:
To investigate if certain nanoparticles found in the blood of granulosa cell
tumour patients, such as circulating tumour DNA (ctDNA) and exosome vesicles
(EVs), can be used as a biomarker in the diagnostic work-up and follow-up of
granulosa cell tumours.
Study design
National multi-center cohort study.
Study burden and risks
Participation in our study will be associated with very minor discomfort. There
are no risks of participation, as we will be using granulosa cell tumour tissue
that is either removed during routine surgery and not needed by the pathologist
for histologic analysis, or has been stored after a surgery in the past. The
only physical discomfort will be the collection of blood samples, if it cannot
be combined with regular blood draws required for diagnosis or follow-up. If we
combine the blood collection with regular blood tests, which we plan to do for
the majority of blood samples, the small amount of additional blood that will
be needed (two tubes) will likely not cause any discomfort. In addition, we do
not expect any site visits other than the regular medical visits, nor any
questionnaires or diaries to be filled in.
Heidelberglaan 100
Utrecht 3508GA
NL
Heidelberglaan 100
Utrecht 3508GA
NL
Listed location countries
Age
Inclusion criteria
Women (of any age)
o Diagnosed with a granulosa cell tumour (now or in the past) OR;
o Suspected of a GCT, scheduled for surgery
Exclusion criteria
If histopathological examination after surgery shows a diagnosis other than a
granulosa cell tumour, this patient will be excluded and will not be followed
during the study period.
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 | NL63786.041.17 |