Health-Economic Evaluation of Early Diagnosis of Epithalial Ovarian Cancer Recurrence Using the ROMA Score: a Prospective Multicenter Randomized Trial

Epithelial Ovarian Cancer Clinical Trial

— ROMECO  

Official title:

Evaluation médico-économique du Diagnostic précoce Des récidives de Cancer épithélial Ovarien Par le Score ROMA : Essai Prospectif Multicentrique randomisé

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05991752
• Other study ID #: DR210313
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: November 2028

Study information

• Verified date: August 2023
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, we hypothesize that calculating the ROMA score (CA125 + HE4 blood marker assay) will enable faster, more targeted diagnosis and management of epithelial ovarian cancer recurrence than the CA125 marker assay alone. This early identification of recurrence would then improve patients' quality of life, since it would increase the chances of benefiting from less invasive and less morbid surgery. It would also reduce the cost of patient management following disease progression. If our hypothesis is confirmed, the results of this study will enable us to update the recommendations for post-treatment follow-up of patients in remission from epithelial ovarian cancer, as well as reimbursing the HE4 marker assay (and thus the calculation of the ROMA score).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: November 2028
• Est. primary completion date: November 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Women aged 18 or over and less than 85 years old

• With proven FIGO stage I to IV epithelial ovarian cancer (ovary/tumor/peritoneum)

• Women in remission after first-line chemotherapy, with a normal CA125 less than 4 months old at study entry (end of first-line chemotherapy).

• Woman having completed chemotherapy at least 6 months previously

• Written informed consent

• French social security

Exclusion Criteria:

• Any physical or psychiatric condition that may interfere with the patient's cooperation in data collection

• Patient with normal CA125 at initial diagnosis of epithelial ovarian cancer

• Patient under guardianship

• Patient deprived of liberty

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms

Intervention

Diagnostic Test:
• ROMA score evaluation
Every 4 months, for 3 years, patients in the experimental group will done a biological examination based on assessment of the ROMA score (CA125+HE4 assay).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental Cost-Utility Ratio (ICUR) expressed as the cost per QALY gained at 36 months of using the ROMA score compared to usual follow-up with the CA-125 test, from the collective perspective.	QALYs (Quality-Adjusted Life Years) will be estimated from patient responses to the EQ-5D-5L instrument (EuroQol group - 5 Dimensions - 5 levels). The cost evaluation will identify, measure and value all the resources consumed in the production of overall care: hospital and outpatient care, transport, informal care, and social aid services. All consumed resources will be estimated from the collective perspective. QALY and cost data will be used to estimate this within-trial ICUR.	36 months
Secondary	Incremental Cost-Effectiveness Ratio (ICER) expressed as the cost per life-year gained at 36 months of using the ROMA score compared to usual follow-up with the CA-125 test, from the collective perspective.	Cost and survival data will be used to estimate the within-trial ICER.	36 months
Secondary	Incremental Cost-Utility Ratio (ICUR) expressed as the cost per QAPFY gained at 36 months of using the ROMA score compared to usual follow-up with the CA-125 test, from the collective perspective.	QAPFY (Quality-Adjusted Progression-Free Years) will be estimated using the progression-free survival data and patient responses to the EQ-5D-5L instrument. Cost and QAPFY data will be used to estimate this within-trial ICUR.	36 months
Secondary	Financial impact per year and over a 5-year period of spreading the use of the ROMA score in the routine follow-up of patients for the diagnosis of the first recurrence of epithelial ovarian cancer.	The financial impact will be estimated from the French Health Insurance, using a budget impact model.	per year and over a 5-year period
Secondary	Characteristics of recurrence between the two groups (i.e. time to recurrence, location and operability)	Proportion of patients with a first operable recurrence, median interval between randomization and diagnosis of recurrence by imaging or biopsy	36 months
Secondary	Characteristics of treatments for first recurrence (including surgery)	Proportion of patients with complete surgery without macroscopic residue, without reoperation, proportion of other therapies: chemotherapy/hormone therapy/other therapies	36 months
Secondary	Quality of life of women	Quality of life assessed by the EORTC QLQ-C30 and EORTC QLQ-OV28 (European Organization for Research and Treatment in Cancer Quality Life Questionnaire) every 4 months for 3 years	36 months
Secondary	Evolution of CA125, HE4 and ROMA score after management of the first recurrence	Description of the evolution of CA125, HE4 and ROMA score after management of the first recurrence	36 months
Secondary	Estimation and validation of a mapping function from the specific EORTC QLQ-C30 and EORTC QLQ-OV28 questionnaires to the generic EQ-5D5L questionnaire.	Deriving the EQ5D-5L score from responses to the EORTC QLQ-C30 and QLQ-OV28 questionnaires in women undergoing post-treatment remission follow-up of epithelial ovarian cancer.	36 months