Primary:To validate the latest version of DySIS in discriminating high grade (HG) from low grade (LG) lesions and non neoplastic tissue as well as in selecting the most atypical site for biopsy sampling, through digital documentation and…
ID
Source
Brief title
Condition
- Other condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Health condition
pre-maligne cervix afwijkingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Consensus in DySIS colposcopic and conventional colposcopic impression of a
lesion and histology (*golden standard*).
Secondary outcome
- Consensus in DySIS colposcopic and conventional colposcopic localization of
the optimal biopsy point and histology (*golden standard*).
- Consensus of DySIS colposcopic and conventional colposcopic impression of a
lesion and HPV GP5+/6+ PCR testing and hybrid capture.
- Higher HPV viral load by a larger, hrHPV positive, lesion.
- A relation between p16INK4a and the size of the lesion.
- A relation between viral load and hrHPV antibody titers.
Amendment:
- Relation between (percursors of) adenocarcinoma of the cervix and hrHPV
positivity in women with normal cytology.
- Relation between visible colposcopic lesions and the histological outcome of
the endocervical sample.
- Relation between hrHPV positivity for the type(s) 16, 18 and/ or 45 with
normal cytology and the outcome of an endocervix sample
- Number of endocervical samples which are unstatisfactory when using the
Kevorkian endocervix curette
- Difference in the detection of endocervical lesions between women who are
hrHPV positive with negative cytology aged younger than 35 years and women aged
35 years or older.
Background summary
DySIS*, developed by Forth-Photonics, is an abbreviation for Dynamic Spectral
Imaging System. With this system it is possible to digitally evaluate and save
colposcopic images.
Study objective
Primary:
To validate the latest version of DySIS in discriminating high grade (HG) from
low grade (LG) lesions and non neoplastic tissue as well as in selecting the
most atypical site for biopsy sampling, through digital documentation and
interpretation of colposcopic images and the correlation with visual
interpretation and histology (*golden standard*).
Secondary:
o Validation of the latest version of DySIS in reducing both inter- and intra-
observer disagreement
o To investigate (feasibility study) the ability of DySIS to identify
hrHPV-positive lesions
o To demonstrate the correlation between the size of a cervical lesion and
hrHPV viral load.
o Comparison of the performances of conventional colposcopy and DySIS in in
vivo identifying hrHPV-positive cervical lesions.
o Correlation of the size of a cervical lesion and p16INK4a expression.
o To demonstrate the relation between viral load and hrHPV antibodies.
Primary objective of the amendment:
To assess the added value of an endocervical sample as a screening tool for
(precursors of) adenocarcinoma of the cervix in women positive for hrHPV with
negative cytology compared to women negative for hrHPV with negative cytology.
Study design
The study is designed as an open, prospective, comparative clinical trial. The
results of colposcopy performed with DySIS will be compared with:
1. The grading of the referral Pap-test.
2. The evaluation of the lesion by the colposcopist using DySIS as a
conventional colposcope.
3. Histology.
4. HPV GP5+/6+-PCR testing.
The size of a possible lesion (determined after processing the DySIS images)
will be compared with:
5. HPV viral load measurements.
6. p16INK4a expression.
Furthermore,
7. HPV E6/E7 antibodies will be compared with viral load levels
8. Endocervical sample
The study group will also be compared with a control group with the aim to test
DySIS in a group of women which is not disease enriched. This control group
will have to meet the same inclusion and exclusion criteria as the study group,
but the women may not have an abnormal cytology test result. In this group, the
chances are substantial, that no (CIN) lesions will be seen during the
colposcopy.
The clinical trial will be divided in three phases:
1. Preliminary data collection
2. Main Study
3. Review of the collected data
Study burden and risks
Participation in this trial means that at least one, but possible two extra
cervical biopsies are taken. From the women in the control group, also an
endocervical sample will be taken. This has the disadvantage that subjects more
often than if they do not participate, are exposed to biopsy/sample taking. The
advantage is, since all the biopsies/samples are studied in the laboratory for
histological lesions, the chance increases that no lesions are missed.
It is not pleasant to have a biopsy or endocervical sample taken, but it is
part of the regular colposcopic examination. Although women often express some
minor pain, it is considered bearable and the blood loss is generally minimal.
A 10 mL bloodsample is also drawn. This sometimes leads to side-effects, but
generally they are not severe and do not last for long.
Despite of the aforementioned, the burden of this trial is, to our opinion,
minimal.
19-21Theofanous Street
GR 115 23, Athene
Griekenland
19-21Theofanous Street
GR 115 23, Athene
Griekenland
Listed location countries
Age
Inclusion criteria
- Female
- At least 18 years of age
- Intact cervix (no history of LEEP or surgical treatment involving damage to the transformation zone of the cervix).
- To be able to undergo a colposcopy.
- Study group only: An abnormal cytological test result and/or positive hrHPV test.
- Controle group: No abnormal cytology or positive hrHPV test.
Exclusion criteria
- History of surgery on the cervix
- Previous pelvic radiotherapy.
- Pregnancy or pregnant in the last 3 months.
- Breast-feeding, or breast-feeding in the last 3 months.
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 |
|---|---|
| ISRCTN | ISRCTN66112760 |
| CCMO | NL16292.029.07 |