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Determination of the Prognostic and Predictive Value of the New Marker HE4 in Metastatic Ovarian Cancer Monitoring


N/A
18 Years
N/A
Open (Enrolling)
Female
Metastatic Ovarian Cancer

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Trial Information

Determination of the Prognostic and Predictive Value of the New Marker HE4 in Metastatic Ovarian Cancer Monitoring


Inclusion Criteria:



- Histologically proved epithelial ovarian cancer (serous, mucinous, clear cell,
endometrioid, undifferentiated type)

- Recurrence of anytime necessitating a new line of chemotherapy

- Patient having received adjuvant chemotherapy

- Informed consent signed prior any study specific procedures

Exclusion Criteria:

- More than 3 lines of chemotherapy

- Pregnancy or breastfeeding

- History of other cancers within the past 5 years (except curatively treated
non-melanoma skin cancer and in situ cervical cancer)

- Psychological, social, geographical disorders or any other condition that would
preclude study compliance (treatment modalities and study follow-up).

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To evaluate the predictive and prognostic value of HE4 marker

Outcome Time Frame:

18 months

Safety Issue:

No

Authority:

France: French National Ethics Committee

Study ID:

Meta-Four

NCT ID:

NCT01768156

Start Date:

January 2011

Completion Date:

September 2013

Related Keywords:

  • Metastatic Ovarian Cancer
  • ovarian cancer
  • biomarker
  • metastatic
  • Ovarian Neoplasms

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