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

NCT02326064 | Completed Results

• 1 other identifier: CHD064-14
• Study Type: observational
• Target: 221
• Locations: 1 country
• Sites: 4

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.

Conditions

Ovarian Tumor; Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• Tumor Marker CA125

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

  Baseline

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient hospitalized for surgery for presumed benign ovarian tumor

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (4)

Centre Hospitalier de Cholet

Cholet, 49300, France

Location

CHD Vendée

La Roche-sur-Yon, 85925, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CH de Saint Nazaire

Saint-Nazaire, 44606, France

Location

Related Publications (2)

• Dochez V, Caillon H, Vaucel E, Dimet J, Winer N, Ducarme G. Biomarkers and algorithms for diagnosis of ovarian cancer: CA125, HE4, RMI and ROMA, a review. J Ovarian Res. 2019 Mar 27;12(1):28. doi: 10.1186/s13048-019-0503-7.

  PMID: 30917847 BACKGROUND

• Dochez V, Randet M, Renaudeau C, Dimet J, Le Thuaut A, Winer N, Thubert T, Vaucel E, Caillon H, Ducarme G. Efficacy of HE4, CA125, Risk of Malignancy Index and Risk of Ovarian Malignancy Index to Detect Ovarian Cancer in Women with Presumed Benign Ovarian Tumours: A Prospective, Multicentre Trial. J Clin Med. 2019 Oct 25;8(11):1784. doi: 10.3390/jcm8111784.

  PMID: 31699959 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Dr. Guillaume DUCARME
• Organization: Centre Hospitalier Départemental Vendée

guillaume.ducarme@ght85.fr

0251446161

Study Officials

• Guillaume DUCARME, PH

  CHD Vendée

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: December 25, 2014
• Study Start: May 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 2, 2025
• Results First Posted: March 15, 2024

Record last verified: 2025-11

Locations

FR (4)