To verify the feasibility of using the Pap-smear in diagnosing endometrial and ovarian cancer.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the correlation between mutations found in the
Pap-smear and the pipelle endometrial sampling and the primary tumor.
Secondary outcome
The main study parameter is the correlation between mutations found in the
vaginal swab and the pipelle endometrial sampling and the primary tumor.
To assess the correlation between the results of the mutation analysis and
tumour characteristics (histology, stage).
Background summary
In 2011, 1257 women in The Netherlands were diagnosed with ovarian cancer and
1913 with endometrial cancer, causing respectively 1043 and 484 deaths. Ovarian
cancer has few symptoms in an early stage and is usually diagnosed in an
advanced stage, leading to a bad prognosis. Endometrial cancer has a better
prognosis, but the incidence is still rising. Earlier detection or even
screening for these diseases would help improve survival. Recent developments
in DNA analysis might be used to diagnose ovarian and endometrial cancer with a
Pap-smear. The possible upcoming change from the traditional screening for
cervical cancer to HPV testing raises a second question whether DNA isolation
is possible from this test as well.
Study objective
To verify the feasibility of using the Pap-smear in diagnosing endometrial and
ovarian cancer.
Study design
Prospective multicentre cohort study.
Study burden and risks
All patients with postmenopausal bleeding are suspected of having endometrial
cancer and therefore undergo a Pap-smear and a pipelle endometrial sampling.
The vaginal swab is an extra test, but this can be performed during routine
gynaecologic examination, which means there will be no extra burden or risk.
Patients suspected of having ovarian cancer and patients undergoing a
hysterectomy for benign pathology normally do not undergo a Pap-smear, vaginal
swab and pipelle endometrial sampling. The Pap-smear and vaginal swab can be
done during routine gynaecologic examination and will not be an extra burden or
risk. The pipelle endometrial sampling is done preoperative, these patients are
sedated and won*t experience extra discomfort and there will be no extra risk.
These diagnostic tests are extensively used by gynaecologists and were proven
to be safe.
Geert Grooteplein 10
Nijmegen 6525GA
NL
Geert Grooteplein 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
Endometrial cancer: patient suspected of having endometrial cancer i.e. postmenopausal bleeding
Ovarian cancer: patient highly (99% certainty) suspected of having ovarian cancer. This will be based on RMI>200, CA125/CEA ratio, ascites, peritoneal depositions, omental cake or even laparoscopic evaluation.
Exclusion criteria
Previous pelvic radiotherapy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL45143.091.13 |
| OMON | NL-OMON22188 |