Ovarian Cancer, Ovarian Tumor
Conditions
Brief summary
Ovarian cancer is the fifth leading cause of cancer death in women worldwide. Most of these cancers are manifested in the form of an ovarian cyst. Practitioners are faced with two main difficulties. The first is to establish an early diagnosis. The second is to differentiate a benign tumor, a malignant tumor. To date, there is only one biological tumor marker routinely performed before an ovarian cyst, the CA-125 (cancer antigen 125). Unfortunately, many studies have been performed and show a sensitivity and specificity unsatisfactory in view of the severity of the disease. The principal investigator therefore propose to evaluate a new tumor marker, as well as its use in algorithms to help differentiate benign from malignant tumors, and allow earlier diagnosis in cases of ovarian cancer.
Interventions
None listed
Sponsors
Centre Hospitalier Departemental Vendee
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients to undergo surgery for an ovarian cyst * presumed benign ovarian tumor (according to the rules of the IOTA(International Ovarian Tumor Analysis Group) group) * agreement to participate in the study
Exclusion criteria
* pregnant patient * minor patient * Patient under guardianship, trusteeship, or deprived of liberty * Patient with ascites or metastases or malignant ovarian mass presumed under the rules of IOTA group. * Patient with an adnexal torsion is suspected * Patient unable to understand the proposed study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Marker CA125 | Baseline | CA125 \< 35U/mL. Abnormal score if CA125 \> 35U/mL. |
| Tumor Marker HE4 | Baseline | HE4 \< 70 pmol/L for premenopausal women or \< 140 pmol/L for postmenopausal women Abnormal score if HE4 \> 70 pmol/L for premenopausal women or \> 140 pmol/L for postmenopausal women |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Women With Benign Ovarian Tumour | 209 |
| Women With Borderline/ Malign Ovarian Tumour | 12 |
| Total | 221 |
Baseline characteristics
| Characteristic | Women With Benign Ovarian Tumour | Women With Borderline/ Malign Ovarian Tumour | Total |
|---|---|---|---|
| Age, Continuous | 46.2 years STANDARD_DEVIATION 15.1 | 53.1 years STANDARD_DEVIATION 16.3 | 46.5 years STANDARD_DEVIATION 15.2 |
| Sex: Female, Male Female | 209 Participants | 12 Participants | 221 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Tumor Marker CA125
CA125 \< 35U/mL. Abnormal score if CA125 \> 35U/mL.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women with benign ovarian tumour | Tumor Marker CA125 | 189 U/mL | Standard Deviation 90.4 |
| Women with borderline/ malign ovarian tumour | Tumor Marker CA125 | 4 U/mL | Standard Deviation 33.3 |
p-value: <0.001Mac-Nemar paired Chi-2 test
Primary
Tumor Marker HE4
HE4 \< 70 pmol/L for premenopausal women or \< 140 pmol/L for postmenopausal women Abnormal score if HE4 \> 70 pmol/L for premenopausal women or \> 140 pmol/L for postmenopausal women
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women with benign ovarian tumour | Tumor Marker HE4 | 191 pmol/L | Standard Deviation 91.4 |
| Women with borderline/ malign ovarian tumour | Tumor Marker HE4 | 6 pmol/L | Standard Deviation 50 |
p-value: <0.001Mac-Nemar paired Chi-2 test