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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02326064
Other study ID # CHD064-14
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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