Trial Outcomes & Findings for Prospective Multicenter Study in Patients With a Tumor Benign Ovarian Presumed on the Use of Algorithms Such as Roma and RMI and Tumor Markers Such as CA125 and HE4 (NCT NCT02326064)

Results Overview

CA125 \< 35U/mL. Abnormal score if CA125 \> 35U/mL.

Recruitment status

COMPLETED

Target enrollment

221 participants

Primary outcome timeframe

Baseline

Results posted on

2025-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	Women with benign ovarian tumour	Women with borderline/ malign ovarian tumour
Overall Study STARTED	209	12
Overall Study COMPLETED	209	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prospective Multicenter Study in Patients With a Tumor Benign Ovarian Presumed on the Use of Algorithms Such as Roma and RMI and Tumor Markers Such as CA125 and HE4

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Women With Benign Ovarian Tumour n=209 Participants	Women With Borderline/ Malign Ovarian Tumour n=12 Participants	Total n=221 Participants Total of all reporting groups
Age, Continuous	46.2 years STANDARD_DEVIATION 15.1 • n=121 Participants	53.1 years STANDARD_DEVIATION 16.3 • n=122 Participants	46.5 years STANDARD_DEVIATION 15.2 • n=243 Participants
Sex: Female, Male Female	209 Participants n=121 Participants	12 Participants n=122 Participants	221 Participants n=243 Participants
Sex: Female, Male Male	0 Participants n=121 Participants	0 Participants n=122 Participants	0 Participants n=243 Participants

PRIMARY outcome

Timeframe: Baseline

CA125 \< 35U/mL. Abnormal score if CA125 \> 35U/mL.

Outcome measures

Outcome measures
Measure	Women with benign ovarian tumour n=209 Participants	Women with borderline/ malign ovarian tumour n=12 Participants
Tumor Marker CA125	189 U/mL Standard Deviation 90.4	4 U/mL Standard Deviation 33.3

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Women with benign ovarian tumour n=209 Participants	Women with borderline/ malign ovarian tumour n=12 Participants
Tumor Marker HE4	191 pmol/L Standard Deviation 91.4	6 pmol/L Standard Deviation 50

Adverse Events

Women with benign ovarian tumour

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Women with borderline/ malign ovarian tumour

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Guillaume DUCARME

Centre Hospitalier Départemental Vendée

Phone: 0251446161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER