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

Ovarian Cancer Clinical Trial

— TORCH  

Official title:

Prospective Multicenter Study in Patients With a Tumor Benign Ovarian Presumed on the Use of Algorithms Such as Roma and RMI (Risk of Malignancy Index) and Tumor Markers Such as CA125 (Cancer Antigen 125) and HE4 (Human Epididymal Protein 4)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326064
• Other study ID #: CHD064-14
• Status: Completed
• Start date: May 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms
• Ovarian Tumor

Locations

Country	Name	City	State
France	Centre Hospitalier de Cholet	Cholet
France	CHD Vendée	La Roche sur Yon
France	CHU de Nantes	Nantes
France	CH de Saint Nazaire	Saint Nazaire

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Marker CA125	CA125 < 35U/mL. Abnormal score if CA125 > 35U/mL.	Baseline
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	Baseline