To identify molecular biomarker profiles that are associated with cervical tumorigenesis, and that can be used for development of an algorithm for detection of low grade CIN1, CIN2, CIN3 and cervical cancer. The algorithm should provide advice for a…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Reproductive neoplasms female benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
: The main study parameter is the difference in gene-expression profiles
between cervical smears from healthy women and women with CIN1, CIN2, CIN3 and
cancer lesions
Secondary outcome
The second objective is to evaluate how gene expression profiles in smears
relate to gene expression profiles in matching dysplastic or cancer tissue.
Background summary
Rationale: Cervical cancer is one of the main gynaecological malignancies
worldwide with worldwide yearly over 500,000 new cases and over 300,000 deaths.
Invasive cervical cancer is preceded by a state of cervical intraepithelial
neoplasia (CIN). The introduction of population-based cervical cancer screening
is known to decrease cancer incidence and mortality by early detection of
high-grade CIN lesions, followed by treatment before these progress into
cancer. Cervical screening starts with a sensitive test to detect high-risk
human papillomaviruses (hrHPVs) in a cervical smear or a self-sampled vaginal
swab. All HPV-positive smears are tested with cytology to identify potentially
aberrant cells (PAP test). All women with a positive test for HPV16 or HPV18
and an aberrant PAP-test (PAP2 and higher) are referred to a gynaecologist for
colposcopy. All women with a positive test for HPV[other] and an aberrant PAP
test (PAP3 and higher) are also referred.
Of all women referred for colposcopy many have no or only low-grade cervical
dysplasia that will spontaneously regress in 90% of cases, causing unnecessary
distress for these women and leading to unnecessary healthcare costs. To reduce
overdiagnosis and overtreatment, novel strategies are needed that more reliably
identify women who are at risk for high-grade dysplasia and invasive cervical
cancer and who require referral for colposcopy.
Study objective
To identify molecular biomarker profiles that are associated with cervical
tumorigenesis, and that can be used for development of an algorithm for
detection of low grade CIN1, CIN2, CIN3 and cervical cancer. The algorithm
should provide advice for a) colposcopy; b) repeat smear in 6 months; c) repeat
smear in 1 year; d) return to normal screening.
Study design
prospective observational study
Study burden and risks
From all women a cervical smear will be taken during colposcopy after VIA and
lugol application. A smear is a well-known and safe procedure that may cause
some discomfort for women. An extra biopsy of the abnormal tissue of women
treated with a biopsy or LEEP does not constitute an additional risk as the
biopsy will be taken from the specimen only after tissue removal. The
pathologist specialised in gynaecological pathology stated that collecting
these samples for research will not interfere with the histopathological
evaluation. In the group of women with cervical cancer an additional biopsy
will be performed when the patient is already anesthetized because of a planned
procedure. Biopsies are associated with a low additional risk (bleeding,
infection) low. Participating in this study will not benefit individual
participants.
Geert Groote Plein Zuid 19
Nijmegen 6525 GA
NL
Geert Groote Plein Zuid 19
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- Age>=18 years
- Signed informed consent
- Women did notno opt-out for making their smear available for research
- Women who undergo a colposcopy examination because of a positive HPV test and
an abnormal PAP-smear.
- Women in follow up after a radical vaginal trachelectomy
- Women diagnosed with cervical cancer
Exclusion criteria
- Women who are pregnant during the colposcopy or surgery
- Women who are not able to understand the study-information
- Women whom did not signed informed consent.
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 | NL83334.091.22 |